Novel therapeutic to aging are creating a market with staying
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A coming of age
Pharmacologic approaches to treating aging are edging closer to maturity
Karen Langhauser Chief Content Director
For the pharma industry, the aging global population is both a testament to its success and a test of its limitations.
Over the past century, pharmaceuticals have played a massive role in increasing life expectancy.
Some estimates suggest that the introduction of antibiotics in the 1920s led to an increase in average life expectancy in the developed world by as much as 20 years. According to a recent WHO report, vaccination has prevented 154 million deaths globally, including 101 million among infants since 1974. In the U.S., innovations in medicine are responsible for more than one third of the improvement in life expectancy from 1990 to 2015, according to a study published in Health Affairs.
But solving one problem invariably creates another. Aging is the dominant risk factor for many of the world’s most common chronic diseases — everything from heart failure to Alzheimer’s to cancer. And multimorbidity is widespread. It’s estimated that 80% of U.S. adults aged 60 and older have two or more chronic diseases.
When the hourglass was invented in the Middle Ages, it had a specific utility: to track time. But the instrument ultimately became a symbolic reminder that the passage of time is unrelenting, and as such, how we spend those hours matters. And I think it’s safe to assume that everyone wants to live out their lives in the healthiest state possible.
When it comes to aging, pharmacologic interventions have mostly been limited to treating the symptoms of one chronic disease at a time. But as you will read in this month’s cover story, many young biotechs have stepped up to the forefront of innovation, offering technology platforms that have produced compelling preclinical research that has the potential to slow the sands of time. Science is edging closer to a single combination gene therapy that can treat multiple age-related diseases in humans. The partial reprogramming of cells’ epigenetic state that could return cells and tissues to a more youthful condition, without altering the cell’s identity, is also within reach.
The result is a longevity market on the brink of coming into its own. Time is a valuable commodity and so too will be anything that can delay or reverse its negative effects.
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Even more valuable than the market longevity therapeutics will create is the promise of transforming the narrative of aging from one of progressive decline to one of sustained vitality.
Reporting on this transformative power of pharmaceuticals has been one of the great privileges of my tenure on Pharma Manufacturing. But sometimes, in both industry and life, in order to embrace progress, you have to flip the hourglass and reset. To that end, after 11+ years of serving the audience of Pharma Manufacturing, I am stepping down from my position as chief content director.
I am confident that the brand will continue to thrive and evolve, much like the industry it covers. To my loyal readers, thank you for your years of trust, support and shared passion for this incredible industry — and welcome to the next era of Pharma Manufacturing.
Karen Langhauser Chief Content Director
Notable 2024 FDA decisions
A look at consequential drug approvals and rejections
When it comes to innovative new treatments, 2023 was a tough act to follow. Novel drug approvals reached an all-time high last year, with the FDA greenlighting 55 new drugs. 2023 was also a breakthrough year for cell and gene therapy, with the FDA approving seven new treatments. We are now more than halfway through 2024 and the FDA has approved 28 new molecular entities, plus three gene therapies and one T-cell therapy. The industry has also seen its fair share of FDA rejections, including some high-profile hopefuls. Here are a few standout regulatory decisions from 2024.
FDA approvals
Alpha Cognition’s Alzheimer’s prodrug
Alpha Cognition’s Zunveyl, an oral treatment for mild-to-moderate Alzheimer’s disease, won approval in late July.
Zunveyl is a prodrug of the well-established Alzheimer’s treatment, galantamine. It was designed to eliminate drug absorption in the GI tract, potentially addressing tolerability issues.
Lilly’s Alzheimer’s anti-amyloid
On July 2, the FDA approved donanemab, after rejecting Lilly’s earlier bid for accelerated approval.
Branded Kisunla, the once-monthly anti-amyloid therapy for early symptomatic Alzheimer’s disease will go head-to-head against Eisai and Biogen’s Leqembi. The Kisunla IV infusion, however, is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which Lilly says can result in lower treatment costs and fewer infusions.
Verona’s inhaled COPD therapy
On June 26, the FDA approved Verona Pharma’s inhaled nonsteroidal nebulizer therapy for the maintenance of COPD, marking the first inhaled product with a novel mechanism of action for COPD maintenance in 20+ years. Ensifentrine, branded Ohtuvayre, is a selective dual inhibitor that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The twice-daily treatment is delivered directly to the lungs through a standard jet nebulizer.
Pfizer’s hemophilia B gene therapy
In late April, Pfizer won approval for Beqvez, a one-time gene therapy for adults with moderate to severe hemophilia B. The treatment is approved for patients who are on routine factor IX (FIX) prophylaxis, those with a history of severe hemorrhage, or those experiencing repeated spontaneous bleeds.
Hemophilia B leads to inadequate blood clotting due to a deficiency in clotting factor IX, resulting in more frequent and severe bleeding episodes. Beqvez is engineered to reduce dependence on frequent FIX infusions, which can be required multiple times per week under the current standard of care.
ImmunityBio’s IL-15 superagonist for bladder cancer
On April 22, the FDA approved ImmunityBio’s Anktiva, an IL-15 receptor agonist immunotherapy for patients with Bacillus CalmetteGuérin (BCG) unresponsive nonmuscle invasive bladder cancer (NMIBC). Patients with unresponsive NMIBC face a higher risk of disease progression to muscle-invasive stages and often require more aggressive treatment approaches.
This was ImmunityBio’s second effort to gain FDA signoff for Anktiva after the agency initially rejected the company’s application in May 2023, citing deficiencies found during an inspection of the company’s CDMO.
Merck’s biologic for PAH
On March 26, the FDA approved Merck’s sotatercept, branded Winrevair, as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH).
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PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. While other drugs on the market treat symptoms of the condition or slow progression, Winrevair has the potential to stop it by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation.
Merck snatched up the drug in its whopping $11.5 billion acquisition of Massachusetts-based Acceleron Pharma back in 2021.
FDA rejections
Lykos’ MDMA PTSD drug
In August, the FDA handed Lykos Therapeutics a CRL for its midomafetamine capsules used in combination with psychological intervention for PTSD.
The issues expressed in the CRL echo those raised during the FDA AdComm meeting back in June, where the Psychopharmacologic Drugs Advisory Committee voted against treatment’s approval on the grounds of both efficacy and risk benefit. The treatment would have been the first psychedelic-assisted therapy approved for PTSD and the first new treatment for PTSD in more than two decades.
Lykos says it plans to request a meeting with the FDA to ask for reconsideration of the decision.
Rocket’s rare disease gene therapy
On June 28, after extending the review period, the FDA issued a CRL for Rocket’s Kresladi, a lentiviral vector-based gene therapy to treat
severe leukocyte adhesion deficiency-I (LAD-I).
Kresladi contains autologous hematopoietic stem cells that have been genetically modified with a lentiviral vector to deliver a functional copy of the ITGB2 gene, which encodes for the beta-2 integrin component CD18.
The NJ-based biotech was hopeful that the therapy could change the treatment paradigm for patients living with severe LAD-I — one of the most aggressive and highly fatal immunodeficiencies ever characterized.
Daiichi Sankyo, Merck’s lung cancer ADC
On June 26, Daiichi Sankyo and Merck & Co. revealed that the FDA issued a CRL for the partners’ jointly developed ADC, patritumab deruxtecan, citing inspection findings at a third-party manufacturing facility.
The partners sought accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have been previously treated with two or more systemic therapies.
AbbVie’s Parkinson’s
combo
On June 25, AbbVie revealed that it received a second CRL for its blockbuster-hopeful treatment for motor fluctuations in advanced Parkinson’s disease, foscarbidopa/foslevodopa, related to inspection issues at a thirdparty manufacturing facility.
ABBV-951 is a solution of carbidopa and levodopa prodrugs for subcutaneous delivery, administered continuously under the skin using a pump.
Saint-Gobain Life Sciences
Emily Alkandry Manager, Analytical Services and Quality Control
Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy.
Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures.
To better understand these challenges, Pharma Manufacturing spoke with Emily Alkandry, analytical services and quality control manager and Gabrielle Wilson, sterility assurance program manager at Saint-Gobain Life Sciences about the importance of comprehensive contamination control strategies for ensuring product quality and regulatory compliance.
What types of contamination can be present in a pharma manufacturing facility, and what risks does this pose?
Emily Alkandry: Contamination in a pharma manufacturing process using single-use technology falls into three categories: particulate, microbiological and chemical contamination. The risk level is tied to contamination characterization and detection ability. Inability to prevent and detect contamination early can jeopardize product quality, patient safety and regulatory compliance.
Particulate contamination is defined as any unintentionally present loose or embedded matter on a
Gabrielle Wilson Sterility Assurance Program Manager
Optimizing contamination control
By minimizing the risks posed by contaminants, pharma manufacturers can prevent costly delays, product recalls and potential harm to patients
single-use component or assembly that may end up in the process fluid. Loose extrinsic particulate poses the highest risk and is the most difficult to characterize, while intrinsic particulate is comparatively lower risk.
Microbiological contamination includes bioburden and endotoxin contamination. High or uncontrolled bioburden levels can threaten the ability to sterilize single-use samples under appropriate conditions, and endotoxin contamination can lead to discarded products.
Chemical contamination requires consideration of material construction and its contribution to the extractables profile of the single-use system. Material selection is crucial, as trace amounts of extracted compounds can alter a drug’s efficacy or be unsuitable for the application.
What is a contamination control strategy and why has it become increasingly important in pharma manufacturing environments?
Gabrielle Wilson: A contamination control strategy (CCS) is a collection of procedures, measures and risk assessments designed to identify, control, monitor and minimize the risk of contamination at a pharma manufacturing site. This includes microbial contamination, endotoxins and particulates.
A CCS calls out critical points in the manufacturing process and details what measures are in place to mitigate contamination risks. It is usually
developed by a cross-functional team with detailed technical and process knowledge and is continuously reviewed and updated.
The importance of CCS has risen due to new guidelines in Annex 1 of the EU GMP guideline, which emphasizes a holistic, risk-based approach to contamination control and requires a CCS at each pharma manufacturing facility. Even small levels of contamination can pose significant risks to patients, making a robust CCS essential for patient health and treatment efficacy. Noncompliance can lead to costly delays, product recalls and damage to a company’s reputation.
What are some of the key elements to be considered within a CCS?
GW: At Saint-Gobain Life Sciences, we recognize the criticality of a strong CCS. Our expertise extends beyond providing high-quality, low-contamination materials and assemblies. We collaborate with our partners to develop tailored strategies for their specific products and processes.
Key elements of a CCS include:
• Facility design: How the facility, equipment, processes and utilities are designed with contamination in mind, supported by validation documentation
• Raw materials handling: How the site handles raw materials and the approval process for key components and single-use system suppliers
• Personnel training: Training and qualification of personnel in gowning, aseptic techniques and cleanroom best behaviors
• Monitoring systems: Environmental monitoring, product testing and all the different monitoring systems at the site
• Risk management: Risk management processes, quality system elements like Corrective and Preventive Actions (CAPAs), trend analysis and investigations
manufacture custom single-use solutions that meet their specific process needs and risk profiles. Customers can leverage our product knowledge and risk assessments for assemblies with representative product sub-visible particulate or bacterial endotoxin claims or use our ISO 17025 accredited test laboratory for lot release testing.
Quality control: Our manufacturing processes adhere to strict quality control standards, including robust cleaning and sterilization procedures,
Even small levels of contamination can pose significant risks to patients, making a robust contamination control strategy essential for patient health and treatment efficacy.
— Gabrielle Wilson
How is Saint-Gobain Life Sciences supporting their pharma partners in compliance with the new Annex 1 guidelines?
EA: Saint-Gobain Life Sciences is committed to helping our pharma partners navigate these new requirements through several initiatives:
Product design and facilities: Our facilities are designed with Annex 1 in mind. We offer single-use components and assemblies made from materials with low-risk extractables profiles, minimizing contamination risks. Our material science knowledge and chemical compatibility guidance help customers make informed decisions about material selection.
Pre-sterilized assemblies: We offer pre-sterilized assemblies to reduce the need for in-house sterilization, a critical control point for microbial contamination.
Custom solutions: We work closely with customers to design and
advanced barrier packaging for stability during storage and transportation, and rigorous quality checks at every stage.
GW: We don’t just react to industry changes; we anticipate them. We’re constantly evaluating and improving our product materials, designs, manufacturing processes and services to align with the most stringent standards, including the updated Annex 1 guidelines.
Saint-Gobain manufactures several materials designed to minimize contamination. For example:
• C-Flex tubing: Engineered for low particulate shedding, maintaining cleanliness in the pharma manufacturing environment
• Sani-Tech platinum-cured silicone tubing: Minimizes the risk of extractables, protecting the fluid inside
• PureFlo filtration products: Incorporate membranes that are absolute rated for efficient reduction of bioburden and particulates; These
high-throughput filters maximize process efficiency and mitigate contamination risk from underperforming filters
• Sterilizing grade filters: Rated for bacterial retention, these filters remove contaminants from both liquids and gases in the single-use process
Our pre-sterilized single-use custom assemblies use secure leak-free connections, such as our patented overmolding technology or BarbLock technology for a 360° compression fit. Our deep understanding of contamination risks and regulatory requirements allows us to guide customers in custom single-use design, selecting appropriate materials and technology for their applications.
What approach has Saint-Gobain Life Sciences developed for cleanroom environmental control?
EA: Saint-Gobain Life Sciences has developed a comprehensive approach to cleanroom environmental control based on controlling individual influential systems to microbial endotoxin and particulate levels. Procedures are in place globally and harmonized at each manufacturing location to reduce and control contamination.
Our contamination control strategy focuses on having all contamination controls, validation and monitoring documented in one governance document. This program explains how all individual elements work together to form a holistic contamination control approach.
Having a documented contamination control strategy allows us to share something tangible with our pharma customers as part of their vendor approval process requirements as laid out in Annex 1.
Karen Langhauser Chief Content Director
N ovel therapeutic approaches to aging a re creating a healthspan marke t w ith staying powe r
From ancient tales of an elixir of life with the power to confer immortality, to stories of a mythical fountain of youth recounted around the world for thousands of years, to modern-day billionaires biohacking their bodies in an attempt to stave off death, humans have always had an obsession with longevity.
For the pharma industry, the quest to live forever or stay eternally young has largely been viewed as an impractical allocation of R&D resources. However, the need to increase humans’ overall healthy, productive lifespan has growing pharmacologic validity, especially because people are now living longer than ever before. By 2030, one in six people in the world will be over age 60; by 2050 that segment jumps to 22%.¹
Aging — while not a disease itself — is the dominant risk factor for many of the world’s most prevalent chronic diseases: cardiovascular conditions such as congestive heart failure and hypertension, metabolic disorders such as diabetes, neurodegenerative diseases such as Alzheimer’s and dementia, and of course numerous types of cancer. And the longer humans live, the more time they have to get sick.
“When people hear you’re working in the aging space, they immediately picture Rip Van Winkle — having the quality of life of a typical 90-year-old for another hundred years — which is not ideal from an individual, family member or medical system perspective,” says Daniel Oliver, CEO and co-founder of Rejuvenate Bio, a 2018
spinout from the Wyss Institute at Harvard. “So it’s important for everybody working in this space to focus not just on mortality endpoints, but also quality of life and health endpoints.”
This shift in focus from lifespan to ‘healthspan’ — the number of years lived versus the number of years lived in good health — reflects a growing recognition of the importance of quality over quantity when measuring longevity. Coined by gerontologists John Rowe and Robert Kahn in their influential 1987 article on successful aging, the concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived
(76.4) and average years lived in good health (63.9).2 ,3
It is estimated that 95% of U.S. adults aged 60 and older have a chronic disease and 80% have two or more.4 Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple chronic diseases simultaneously?
Armed with compelling preclinical research and novel genetic medicines, these biotechs are looking to close the gap between healthspan and lifespan with the ultimate goal of ushering in a new, comprehensive therapeutic approach to aging.
The birth of longevity therapeutics
While many clever quips about gaining grace and wisdom with old age abound, aging, at its core, involves the progressive decline of numerous physiological processes. Over time, cells lose their ability to function, leading to the deterioration of tissue and organs. These declining functions leave individuals less able to handle various stresses and more vulnerable to disease.
Research over the last decade plus has sought to understand the specifics of why aging happens. In 2013, molecular biologist Carlos López-Otín and colleagues attempted to categorize the cellular and molecular drivers of aging by proposing nine (later expanded to 12) common hallmarks of aging (see sidebar).
The hallmarks can be divided into three groups: primary, antagonistic and integrative. The primary hallmarks of aging, such as genomic instability or epigenetic alterations, start the
process, producing damages that accumulate with age. The antagonistic hallmarks, such as mitochondrial dysfunction and cellular senescence, start out beneficial but over time increase in intensity and become harmful. Finally, the integrative hallmarks, such as stem cell exhaustion and chronic inflammation, make their appearance after damage from the first two groups overrides the body’s homeostasis mechanisms.5
While these hallmarks are not definitive, Otin’s research has reinforced the idea that there isn’t a singular cause of aging. Understanding the interconnectedness of these various drivers can help unlock the key to treating aging through an emerging class of drugs collectively referred to as longevity therapeutics.
“We strongly believe that longevity therapeutics could shift the focus from treating symptoms of aging to addressing its root causes, potentially reducing the prevalence of multiple age-related diseases,” says Thomas Solbach, partner at Strategy&, PwC’s strategy consulting business.
In the U.S., the average life expectancy is 76.4 years, while the average number of years that a person can expect to live in full health is 63.9 years.
— World Health Organization
But in doing so, drug developers would upend the pharma industry’s conventional approach to treatment of age-related diseases — which has, for the most part, been one chronic disease at a time.
Solbach describes it as a “paradigm shift in health care,” — the idea that conventional therapies that individually target chronic disease could be replaced by longevity therapeutics that would markedly improve healthspan by simultaneously going after multiple chronic diseases.
Research published in 2019, led by Rejuvenate Bio co-founders Noah Davidsohn and George Church, sought to acknowledge the interconnectedness of age-related conditions by creating adeno-associated virus (AAV)-based anti-aging gene therapies for simultaneous treatment of several age-related diseases in mice.6
“Noah and George were able to show that one treatment could have efficacy across a model of cardiac disease, renal failure and induced diabetes and obesity,” says Oliver. “That initial paper confirmed the idea that one treatment could, by generally making your patient healthier, be able to treat multiple chronic diseases across multiple classes. And it became really intriguing to try to create a new therapeutic class.”
If the idea of a mega-treatment, capable of making people healthier by attacking multiple conditions at once sounds familiar, it’s because the industry currently has a wildly successful example of this concept.
“If you look at the GLP-1 drugs, almost all of them started in the metabolic space and now they’re moving into cardiac and renal as well,” says Oliver. “GLP-1s are paving the way for an interest in this type of technology where people do believe that
you could create one therapy that is able to treat multiple different indications and really change the health of the patient, not just a very specific disease or a specific problem.”
As research continues to unlock these interconnected biological drivers of aging, the potential for therapeutics that address chronic disease multimorbidity becomes increasingly tangible.
Crawl before you run
Despite encouraging preclinical progress, the longevity space has suffered its share of snake oil promises from bad actors, which has only muddied the waters for those offering legitimate science. Both regulators and investors require evidence, and for drug developers, that means traversing the so-called ‘valley of death’ — the perilous gap between preclinical research and clinical applications.
“We have cured every mouse on earth of every disease known to humankind. The only way to learn how to treat disease is to treat people with the disease,” pointed out Fyodor Urnov, co-founder of epigenomic therapy biotech Tune Therapeutics, in a recent podcast.7
But the path to simultaneously treating multiple-age related conditions starts by picking a target to aim for in the clinic, whether age-related or not, that can have the biggest impact on patient populations.
“A big part of all of this is proof. When we started, we absolutely were utilizing factors that have been demonstrated in aging studies, but we didn’t know if they were going to be a game-changing cardiac therapy,” says Oliver. “And so, for instance, our initial programs, and you could have classified those as anti-aging gene therapies, but we’re now working in partnerships with animal
Aging is the single largest risk factor for many chronic conditions
and human health companies on a cardiac-focused gene therapy with label expansion opportunities.”
Rejuvenate Bio is currently working to establish the safety and commercial viability of its preclinical drugs in areas of unmet need. Rejuvenate’s pipeline consists of treatments in both the human and animal health space, and the company is utilizing a similar approach to development in both areas.
Building on research conducted at Harvard Medical School and the Wyss Institute by co-founder George Church, Rejuvenate is developing a AAV gene therapy
treatment for the leading type of heart failure in dogs, mitral valve disease. The company has partnered with Phibro Animal Health for the development and commercialization of the therapy, RJB-01, which they hope will provide an early revenue stream to further develop the company’s human clinical programs.
“This is particularly illustrative of the power of the type of technology we are working with. One of the things this partnership implies that is intriguing for the general market is that these types of therapies can work for these blockbuster indications. We’re not talking about a specific genetic niche; the manufacturing costs and the scale that we can manufacture these on are relevant for millions of patients,” says Oliver.
There are an estimated 90 million dogs in the U.S. and about 10% of the canine population has some sort of cardiac condition, meaning there are millions of potential furry patients for Rejuvenate’s treatment.
Similar to its animal health drug, Rejuvenate’s most advanced human candidate, RJB-0402, is a liver-directed AAV gene therapy delivered as a one-time intravenous injection. The company shared preclinical data for the treatment last year, demonstrating efficacy in a mouse model of arrhythmogenic cardiomyopathy (ACM), an inherited disease caused by mutations in one of several genes encoding proteins in parts of the cardiac muscle known as desmosomes.8
While not a disease typically associated with aging, ACM presents a profound unmet medical need, as there are no disease-modifying treatments, other than cardiac transplant for latestage disease.
“I think it’s important to take really logical steps, attack particular indications, in particular organs or tissue
Now that we have developed tools that can precisely alter the epigenome, it’s become almost an obvious way to utilize these tools to treat diseases that have these epigenetic bases.
— Jennifer Kwon
areas, to understand what we’re doing and start moving that forward. But these things have a way of accelerating,” says Oliver.
Rejuvenate has already completed a pre-IND meeting with the FDA for RJB-0402 in ACM. Beyond this specific type of cardiomyopathy, Rejuvenate believes its gene therapy could expand into other cardiac indications, such as heart failure, and both the metabolic and renal space.
Tune Therapeutics, launched in 2021 by a veteran team that includes co-founders Akira Matsuno, Fyodor Urnov and Charles Gersbach, is taking on hepatitis B (HBV) with its experimental treatment, TUNE-401, which the company hopes to bring to the clinic by the end of the year. TUNE-401 represents a fundamentally new approach to HBV treatment in that it utilizes the company’s precision genetic tuning platform, TEMPO, to inactivate viral DNA integrated into host chromosomes, while simultaneously silencing the extra-chromosomal ‘viral factories,’ known as covalently closed circular DNA (cccDNA), necessary for sustained HBV infection.
Although an effective vaccine for HBV exists, it’s estimated that 296 million people worldwide are living with the virus.9 For most HBV patients, current standard of care treatments have proven insufficient to clear infection, leading to a lifelong, chronic condition. Tune’s therapy, however, could offer the first functional cure.
“A low percentage of patients can actually get a functional cure without drug intervention through epigenetic silencing of the hepatitis B virus DNA,” explains Jennifer Kwon, founding principal scientist at Tune. “And we can mimic that same type of process by sending our epi-editing tool to target that particular sequence.”
Since there is no large animal model available to study HBV, Tune used a surrogate target, PCSK9, to demonstrated durable, liver-directed epi-editing in non-human primates. In the liver, the PCSK9 gene provides instructions for making a protein that regulates cholesterol level; repressing it reduces elevated LDL-cholesterol (aka ‘bad cholesterol’) levels.10
“We were able to dose monkeys one time with the epi-silencer, reducing the PCSK9 levels and subsequently lowering their cholesterol levels for over a year, with measurements still ongoing,” says Kwon.
The breakthrough research, led by Kwon, demonstrated that genetic tuning can drive the stable repression of PCSK9 following a single treatment, showcasing the potential to develop genetic tuning into a robust therapeutic modality for the treatment of other common chronic diseases.
The epigenetics leap
The epigenetics-based treatment undertaken by Tune forays into the area of longevity therapeutics that has captured significant public attention. Although often accompanied by splashy headlines teasing an ‘ageless future’ or the ‘pursuit of
Twelve hallmarks of aging
1. genomic instability
2. telomere attrition (shortened telomere ends of chromosomes)
3. epigenetic alterations
4. loss of proteostasis (bone function)
5. disabled macroautophagy (skin homeostasis)
6. deregulated nutrient-sensing
7. mitochondrial dysfunction
8. cellular senescence
9. stem cell exhaustion
10. altered intercellular communication
11. chronic inflammation
12. dysbiosis (disruption to the microbiome)
hallmarks
immortality,’ recent advances have backed the validity of new epigenetic reprogramming tools and the possibility of using targeted therapeutic interventions to influence the epigenetic regulation of specific genes.
The concept of epigenics dates back to the work of British biologist Conrad Waddington in the 1940s, who used the term to discuss the impact of genetic and environmental influences on cell type and tissue formation during embryonic development. It is now understood that the epigenome, a multitude of chemical tags attached to DNA and its surrounding proteins, directs gene expression and behavior.11
But as we age, gene expression can go awry, leading to silent genes becoming activated and healthy genes being silenced. Many common diseases, such as cancer, are caused or made worse by this epigenetic regulation mechanism malfunctioning.
“Now that we have developed tools that can precisely alter the epigenome, it’s become almost an obvious way to utilize these tools to treat diseases that have these epigenetic bases. That’s why epigenetics and treating age-related diseases go hand-in-hand,” says Kwon.
Apropos to its name, Tune aims to effectively orchestrate different gradiations of the epigenome. Using its TEMPO genetic tuning platform, the company can turn up the volume on genes required for healthy cells and tissue or turn down the volume on genes that cause or contribute to disease, ultimately rebalancing levels of gene expression.
In 2006, Japanese physician and researcher Shinya Yamanaka — who later went on to win the 2012 Nobel Prize in Physiology or Medicine for his work — discovered a set of four specific genes that can reprogram mature, differentiated cells into a pluripotent stem cell state. These ‘Yamanaka factors’ work together to reset the cell’s developmental clock, effectively turning specialized cells, such as skin cells, back into a state of pluripotency, where the cell has the ability to develop into almost any type of cell.12
Earlier this year, Rejuvenate published preclinical research detailing how researchers were able to double the remaining lifespan of elderly mice by delivering these Yamanaka factors via gene therapy.13
“The idea here is not necessarily just delivering particular genes that encode for a protein or two, but really creating a therapy that changes the epigenetic state of a patient such that their cells, and more importantly, the gene expression profile that’s driving how their body is acting, is changed back to what it was when that patient was healthier,” says Oliver.
Importantly, the study results may have implications for the development of partial reprogramming interventions to reverse age-associated diseases in elderly humans and potentially extend human lifespan.
“And this really illustrates the excitement around epigenetic reprogramming, which is this idea of reversal. Can we reverse the state of these patients such that their body’s operating a way that’s more akin to what it was when it was younger/healthier?” says Oliver.
Making the golden years shine
While excitement alone does not a market make, the urgent unmet needs related to chronic disease and multimorbidity faced by the aging population are increasingly difficult to ignore.
LÓPEZ-OTÍN, C., ET. AL. HALLMARKS OF AGING: AN EXPANDING UNIVERSE. CELL. (JAN. 19, 2023).
The U.S. is experiencing unprecedented growth of the 65 and older population. And while more people are living longer lives, they aren’t necessarily living healthier lives. By 2030, an estimated 83.4 million people in the U.S. will have three or more chronic diseases, compared with 30.8 million in 2015.14 This shift will invariably affect federal assistance programs for the aging population, such as Social Security and Medicare. Fifty years ago, Social Security and Medicare spending accounted for 20% of the federal budget; those programs now account for more than one-third of federal spending.15
One analysis of the economic value of targeting aging with treatments found that improving health by “compressing morbidity” — a concept put forth by healthy aging pioneer James Fries that hypothesizes that delaying the onset of illness can compressed disease burden into a shorter period — is more valuable than simply increasing life expectancy. The study used a statistical model to assign a monetary value to healthy aging, claiming that a slowdown in aging that improves health and increases life expectancy by one year is worth $38 trillion, and by 10 years, $367 trillion.16
Despite what appears to be an urgent imperative, the broader pharma industry is moving tentatively when it comes to treatments that target the biological drivers of aging. “Large pharma still seems hesitant to invest,” says Solbach. “But entering the nascent longevity market offers significant advantages for large pharma companies and investors, such as first-mover advantage, substantial market share, and potential for high returns.”
Theoretically, this longevity treatment market would comprise several multi-billion dollar markets — one for each chronic disease that affects the aging population — and, since aging is currently inevitable, it would consist of close to 8 billion potential customers.
The space is not entirely without investment from multinational pharma companies, however. AbbVie has had a partnership in place with Alphabet-founded Calico Life Sciences since 2014 focused on the biology of aging and first-in-class targets for age-related diseases. In 2016, precision medicine company Human Longevity signed a 10-year deal with AstraZeneca to sequence and analyze DNA samples from AstraZeneca clinical trials. The San Diego-based venture also signed similar deals with Roche’s Genentech and Celgene. In 2020, Fountain Therapeutics, a biotech focused on treating diseases by reversing cellular age, was selected by Eli Lilly to move its corporate headquarters to the Lilly Gateway Labs in San Francisco. More recently, Genentech signed a licensing deal with Sangamo Therapeutics to develop intravenous genomic medicines to treat certain neurodegenerative conditions, including Alzheimer’s disease.
While epigenomic reprogramming to reverse age-associated disease or proactively prevent it is likely still years away in humans, savvy biotechs navigating this exciting space are taking a practical approach to tackling the looming public health crisis of an aging population.
“When they say ‘fountain of youth,’ that just sounds like a myth, but in reality it’s about treating the cardiovascular diseases, trying to prevent diabetes and eventually treating these age-related diseases sooner. That’s the practice of it,” says Kwon. “I think all of these things are feasible and look forward to being a part of developing them.”
References
1. Ageing and health. The World Health Organization. (Oct. 2022).
2. Rowe, J.W. and Kahn, R.L. Human Aging: Usual and Successful. American Association for the Advancement of Science. (Jul. 10, 1987).
3. World Health Organization Data. Life expectancy at birth, healthy life expectancy at birth. Accessed: Aug. 12, 2024.
4. Get the Facts on Healthy Aging. National council on aging. (Aug .16, 2024).
5. López-Otín, C. et. al. The hallmarks of aging as a conceptual framework for health and longevity research. Frontiers in Aging. (Jan. 14, 2024).
6. Davidsohn, N. et. al. A single combination gene therapy treats multiple age-related diseases. PNAS. (Nov. 4, 2019).
7. Perfect Pitch: Genome Editing Pioneer Fyodor Urnov on Commercializing CRISPR Therapies and Epigenomic Tuning. Close to the Edge podcast. GEN. (Aug. 30, 2023).
8. Rejuvenate Bio Announces Preclinical Data for Gene Therapy Candidate RJB-0402. (Press release). (Oct. 9, 2023).
9. Keat Kang, C., et. al. How to Effectively Monitor Aging Patients with Chronic Hepatitis B: A Review. Clin Interv Aging. (Dec. 9, 2022).
10. Cosgrove, Brian. Epigenetic editing for the treatment of HBV. (Presentation). Tune Therapeutics. (Dec. 5, 2023).
11. Ospelt, C. A brief history of epigenetics. Immunology Letters. (Sept. 2022).
12. Yamanaka, S. and Takahashi, K. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell. (Aug. 10, 2006).
13. Noah Davidsohn, N. et. al. Gene Therapy Mediated Partial Reprogramming Extends Lifespan and Reverses Age-Related Changes in Aged Mice. Cellular Reprogramming. (Feb. 15, 2024).
14. Waters, H. and Graf, M. The costs of chronic disease in the U.S. Milken Institute. (Aug. 2018).
15. How Does the Aging of the Population Affect Our Fiscal Health? Peter G. Peterson Foundation. (May 2024).
16. Scott, A., et. al. The economic value of targeting aging. Nature Aging. (Jul. 2021).
Andrea Corona Senior Editor
Fishers: From farm to pharma
How a once-quiet agricultural town in Indiana evolved into a life sciences hub through strategic collaboration, talent cultivation and visionary leadership
When Colonel Eli Lilly, founder of Eli Lilly and Company, purchased land and a house north of the capital city of Indianapolis in 1934, he likely had no idea that he was investing in what would later become the growing pharma hub of Fishers, Indiana. While Lilly’s investment in the area was initially personal, it foreshadowed the city’s evolution into a key player in pharmaceuticals.
Established in 1872 as Fishers Switch, the town remained a modest farming community for much of its early history. But the city has recently experienced rapid population growth, increasing from 9,000 residents in 1990 to over 105,000 in 2024, making it one of the fastest-growing cities in Indiana.
This surge wasn’t just about increasing numbers; it was about attracting and nurturing the right kind of growth — one centered around a
highly educated, motivated population ready to contribute to an expanding economy.
And the influx of talent didn’t happen by accident. Fishers has cultivated an environment that balances quality of life with professional opportunity, making it an attractive destination for both families and businesses.
“When you examine heat maps and educational attainment, you’ll find a highly concentrated population with life sciences backgrounds here in Fishers,” explains Megan Baumgartner, director of economic and community development in Fishers.
The result is a city that not only attracts businesses but also retains them, fostering an environment where both companies and their employees can thrive. Today, Fishers is a testament to how thoughtful development, a well-educated workforce and visionary leadership can transform
a once-quiet agricultural town into a thriving epicenter for biotech and pharmaceutical innovation.
Visionary governance
The transformation of Fishers into a life sciences hub is as much a story of strategic governance as it is of growth.
Mayor Scott Fadness reflects on this journey, “Our first foray into that was really in the tech sector. We spent a lot of time in the entrepreneurial movement trying to support startups and technology companies. Launch Fishers, the largest coworking space in Indiana, and Indiana the Internet of Things Lab [a 24,562-square-foot lab based in Fishers that enables entrepreneurs to work on embedded technology] were pivotal in creating a culture of innovation that naturally extended into life sciences.”
This forward-thinking approach wasn’t limited to fostering startups; it
extended to creating tailored solutions for established companies looking to expand in Fishers. Each business partnership is approached with a mindset of collaboration, ensuring that companies not only feel welcomed but also supported in their longterm growth. As Baumgartner puts it, “Every deal that we have done is different and unique and fits the needs of that company.”
In 2020, amid the city’s entrepreneurial movement, Baumgartner and Fadness were introduced to Cory Lewis and the INCOG BioPharma team through an attorney. As a young CDMO seeking a location to establish roots, INCOG quickly formed a connection with the local government.
“The connection was less about their specific industry and more about our shared approach to entrepreneurship. Our common ground was our mutual commitment to rapid market entry and supporting entrepreneurs as they launch new ventures — exactly what INCOG was aiming to achieve,” says Fadness.
INCOG’s 90,000-square-foot facility in Fishers includes cleanrooms, flexible filling lines for vials, syringes and cartridges, lyophilization capabilities, and quality control labs. It is built to meet FDA and EMA standards, focusing on aseptic fill-finish services for biologics and injectable therapies.
The city has confidently positioned itself as a life sciences hub by purchasing and developing the Fishers Life Sciences & Innovation Park, a 70-acre site aimed at attracting industry leaders. Fishers offers significant tax incentives, including property tax abatements of up to 100% for 10 years and potential state-level benefits such as R&D tax credits and workforce training grants.
Since 2020, this approach has yielded impressive results — $850 million in new investment and 1,800 new jobs in the life sciences sector alone, with an average salary of $77,000. For a city of its size, this level of per capita impact is extraordinary, marking Fishers as a standout in the region.
The city’s leadership understands that fostering a strong business environment requires more than just offering incentives; it’s about building relationships and creating a community where companies can see a future.
Genezen, a CDMO focusing on viral vectors, has directly benefited from this collaborative environment. “Fishers has been really great at looking for ways to
partner with us in terms of fueling our growth. Scott [Mayor Fadness] and I have spent a lot of time together, discussing what is really important for an operations business like ours to grow in Indiana,” says Steve Favaloro, Genezen’s CEO.
Genezen’s site in Fishers spans over 75,000 square feet and includes multiple CGMP-compliant suites, dedicated areas for process development, analytical testing and quality control. The facility is equipped with advanced bioreactors, automated systems for cell processing, and scalable production capabilities to support both clinical and commercial manufacturing needs.
A robust talent pipeline
One of Fishers’ greatest strengths lies in its ability to attract and cultivate talent.
The city boasts a highly educated population, with 65% of residents holding a bachelor’s degree and nearly 25% holding a graduate degree. Indiana’s education system is a powerhouse and serves as a backbone for the life sciences and manufacturing sectors, anchored by top institutions like Purdue University, which excels in analytical chemistry and biological engineering, and Indiana University, home to the nation’s largest medical school. Ivy Tech Community College, with 40 statewide locations, further supports the industry by offering specialized certificates in pharma manufacturing.
“The advantages of being in Fishers are significant,” notes Favaloro. “You have access to a really great talent pool, including graduates from Purdue and IU. The presence of Lilly on
The Fishers Life Sciences & Innovation Park is a 70-acre site aimed at attracting industry leaders.
a national scale is tough to understate. As more companies grow here, they bring in talent, not just for short assignments, but to build lives and careers in the area.”
This concentration of skilled professionals is a major draw for companies looking to establish or expand their operations in Fishers. Within a 40-mile radius of Fishers, there are more than 55,000 people employed in life science-related roles.
Fishers consistently ranks as one of the best places to live in the U.S., offering excellent schools, safety and a balance between work and personal life. This makes it easier for companies to recruit and retain top talent, a factor that is becoming increasingly crucial in pharma.
The city offers a robust job market, drawing in a large pool of talent, making it easier for companies to recruit the specialized workers they need. This talent pool is not just limited to recent graduates; many experienced professionals from out of state and even internationally are choosing to make Fishers their home, drawn by the city’s quality of life and professional opportunities.
“Many of these jobs offer employees the flexibility to leave during the day or at lunchtime and visit one of our main districts for a meal,” says Baumgartner. “Additionally, working closer to home, rather than commuting to downtown Indianapolis, is highly appealing to many. This also provides an advantage from a job recruitment perspective.”
Filling a void
Fishers’ location is another key factor in its rise as a life sciences hub.
Situated near major logistics hubs, including the FedEx Hub and Indianapolis International Airport, the city offers unparalleled access to key
transportation routes. This makes it an ideal spot for pharma manufacturing and distribution, especially for companies looking to optimize their supply chains.
Indiana is home to major pharmaceutical and biotech companies like Eli Lilly, Roche Diagnostics and Catalent Pharma — a factor that Mayor Fadness and his team were inspired to complement. “With some of the world’s largest drug companies headquartered in Indianapolis, you’re not compromising quality by choosing to reduce costs by 35% and relocating your manufacturing operations to central Indiana,” says Fadness.
Moreover, Fishers offers something that other major life sciences hubs like Boston or San Diego can’t — affordability. The cost of real estate and labor is considerably lower, providing companies with a financial edge without sacrificing quality.
“I was just in a conversation with someone yesterday who told me that there was a life sciences company in Boston that signed a 10-year lease for a two-story office building, and the liability on it was $38 million for the rent over 10 years. In central Indiana, you could build your manufacturing facility for $38 million,” says Fadness.
This cost-effectiveness is coupled with the availability of land, a resource that’s increasingly scarce in more established hubs. Fishers offers ample space for companies to establish and expand their operations, making it an attractive option for those looking to grow without the prohibitive costs associated with larger cities.
As more companies grow here, they bring in talent, not just for short assignments, but to build lives and careers in the area.
— Steve Favaloro
Hand-in-hand
Fishers is not resting on its laurels.
The city was recently designated as one of 31 regional tech hubs under the federal CHIPS and Science Act, opening the door to significant federal funding aimed at advancing biotechnology development.
This designation positions Fishers to compete for up to $75 million in grants, further strengthening its stake as a burgeoning hub for medical and biotech industries.
Fishers continue to see significant investments in life sciences infrastructure, such as Genezen Labs’ $7.8 million investment in a new clean manufacturing facility in 2020 and Stevanato Group’s $145 million investment in a new facility to support production of its pre-sterilized drug containment systems.
The success of Fishers as a life sciences hub is not just a story of growth but of thoughtful planning, strategic partnerships, and a commitment to creating an environment where businesses can thrive.
As more companies recognize the advantages of establishing operations in Fishers, the city is poised to become a leading player in biotech and pharma, not just in Indiana but across the country.
“Fishers is still in the early innings of becoming a major biotech hub, but it has all the right things to continue growing significantly,” says Favaloro.
Ioanna Deni Research Scientist, BioPlan
Embracing single-use innovations in a post-COVID era
Continued growth and standardization will depend on suppliers innovating to overcome challenges
The COVID-19 pandemic highlighted an important turning point for the adoption of single-use systems (SUS) in biopharmaceutical production.1 The need for large-scale production of vaccines and therapeutics created extreme pressures to respond quickly and responsibly.
Many biomanufacturers responded to the global threat by expanding capacities with SUS technologies. The pandemic rapidly accelerated the recognition that commercial scale production could be done faster, and possibly cheaper, than with stainless steel equipment.
Pre-COVID, SUS advances were generally limited to operations at scales beyond 2,000 liters; today, 87% of manufacturing facilities are incorporating SUS technologies. By examining nearly two decades of data, the BioPlan Associates 21st Annual Report and Survey of Biopharmaceutical Manufacturing has identified the top single-use technologies that have become integral to biomanufacturing since 2006.2
SUS are involved in a wide range of processes, both upstream and down. It has been well documented that SUS offers advantages including flexibility, reduced risk of cross-contamination and lower initial capital investment.
MICHAEL ANNINO
Frequently, these systems are integrated into larger, ‘hybrid’ manufacturing strategies that combine stainless steel and SUS technologies, offering a balance of scalability and flexibility.
While market adoption of SUS doubled within the first few years, adoption is leveling off after this initial market penetration. Although concerns about cost, breakage and scalability remain in the minds of bioprocessing professionals, SUS industry suppliers have continued to innovate, making SUS a mainstream platform.
Scaling adoption plateaus
The biopharma industry has experienced a transformative shift towards the rapid adoption of single-use products and devices over the past two decades. Looking at the new expenditures focus areas cited by 2024 respondents in BioPlan’s report, we see that single-use bioreactors will maintain their profitability amongst other SUS in facilities (Exhibit 1).
The category with the largest investment has been single-use products, which have become increasingly popular. Single-use bioreactors, a pivotal innovation for cultivating cells and producing biologics, are also a great investment, having been used by 64.2% more facilities since 2006. Unlike traditional stainless steel bioreactors, which require extensive cleaning and validation between batches, single-use bioreactors use disposable bags that are replaced after each production cycle. This reduces downtime and significantly lowers the cost of production, making them an attractive option for both small and large scale manufacturing.
Facilities are also seen to spend almost 20% of their capital on SUS mixing systems, designed for the preparation and homogenization of complex media and solutions. The
EXHIBIT 1
Top new bioprocessing expenditures for facilities (2024)
DISPOSABLE /SINGLE-USE: PRODUCTS, BAGS, CONNECTORS, ETC.
systems offer significant advantages, especially in switching between different production runs. As more molecules progressed from clinical production to commercial manufacturing, facilities adopted more SUS technologies to support growth of their new molecules.
One of the primary reasons for the high adoption of SUS is the reduction in capital investment required for facilities and equipment. This benefit is particularly attractive to manufacturers focused on enhancing productivity and achieving shortterm cost savings. By minimizing the need for expensive infrastructure, SUS allows companies to allocate resources more effectively, contributing to a decrease in overall facility costs. Thus, we see an investment by facilities on low-cost SUS devices.
However, as the industry surpasses the COVID surge, the explosive growth of these established single-use products and devices is beginning to plateau. In 2024, the annual growth rate of single-use bioreactors slowed to between 1.6% and 3.5% CAGR. This percentage is not indicative of declining SUS need, but rather a sign that the market has reached a level of saturation as the industry now looks towards the next wave of innovation to drive future growth.
A new area of focus is single-use control systems. The systems are components within bioprocessing equipment designed to monitor, regulate and automate various aspects of single-use technologies. These are specifically developed to work with single-use bioreactors, mixers, filtration systems and other disposable technologies.
Features of single-use control systems
Single-use control systems include sensors and software that monitor critical process parameters such as temperature, pH, dissolved oxygen, pressure and flow rates. These systems ensure that the bioprocess environment remains within the desired range for optimal cell growth or product formation. They also are easily
adjustable to different production volumes during clinical trials or in response to changing market demands.
The systems often include automation capabilities that allow for precise control of the bioprocess. This might involve adjusting the flow of gases, liquids or nutrients automatically based on real-time data, which reduces the need for manual intervention and increases process consistency. They also provide robust data management features, ensuring that all critical data is recorded and stored in compliance with regulatory requirements.
They also have some limitations. First, single-use control systems are designed for one-time use, which can lead to higher operational costs due to the need for new components for each batch. Additionally, although designed to work with disposable systems, integrating single-use control systems with existing infrastructure can be complex, particularly in ‘hybrid’ facilities that operate both traditional and single-use technologies.
Some challenges shared between single-use control systems and other SUS include concerns about leachables and extractables as well as about waste disposal and the generation of plastic waste. The industry is already making early strides to overcome these issues by focusing on durable new materials that are designed to be more compatible with biopharma processes, significantly reducing the risks associated with leachables and extractables. In addition, efforts to create eco-friendly
materials and processes have helped mitigate the environmental impact.
The ability of all SUS to adapt to the industry’s concerns while enhancing production efficiency and flexibility has driven their adoption across stages of manufacturing.
Top adoptions for expansion
As production demands continue to rise, nearly half of industry experts anticipate that their current facilities will struggle to keep pace over the next five years.2 This concern reflects the inherent difficulty in facility planning, where predicting future capacity needs often reveals the inevitability of outgrowing existing infrastructure. Historically this has been a persistent trend, but SUS are emerging as a pivotal solution to overcome this.
SUS have been frequently cited by industry leaders as a key strategy to avoid capacity bottlenecks. The inherent flexibility of SUS allows for rapid scalability, enabling facilities to adapt more swiftly to changing production demands without the need for extensive infrastructure overhauls. By minimizing the reliance on fixed stainless steel systems, which require significant space and extensive validation processes, SUS offer a more adaptable and cost-effective approach to facility expansion. This flexibility not only mitigates the risk of outgrowing current facilities but also provides a pathway for more efficient and agile manufacturing operations in the future. As such, SUS are increasingly recognized as an essential component in the strategic planning of facilities aiming to stay ahead of capacity constraints.3
Automation is also seen as a critical factor in alleviating capacity constraints (Exhibit 2), as it allows for more efficient and consistent bioprocessing operations. We expect to see the integration of automation in
EXHIBIT 2
SUS via SUS advanced digital monitoring and control technologies. These will allow real-time oversight of critical process parameters and enhancement of both process control and product quality. Furthermore, automation will reduce the likelihood of human error, leading to more reliable and reproducible results. As facilities grow in size and complexity, the integration of advanced automated SUS becomes essential for maintaining operational efficiency and scaling up production.
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Following the advancements in SUS, the industry is showing interest in modular bioprocessing units and single-use facilities as a solution to capacity constraints. Modular systems consist of connectable, portable cleanrooms or isolator units that can be quickly assembled and become operational within weeks or months. Offering similar benefits to single-use facilities, these systems provide a flexible, scalable and rapid solution for expanding production capacity.
The concept of ‘plug-and-play’ factories, where entire production lines can be easily replicated and deployed, is gaining traction. Companies like Cytiva, G-Con and Pharmadule are at the forefront of developing modular bioprocessing units that function as fully disposable, single-use systems within portable, self-contained trailers or cleanrooms.
These modular systems are particularly advantageous for applications that require urgent and rapid responses, such as epidemic vaccine production or biodefense. They are also ideal for scenarios where short-term demand is expected, or where high safety standards necessitate the quick setup of on-site facilities. The adoption of modular platforms in commercial manufacturing is expanding. Our recent survey found that over 5% of bioprocessing facilities reported plans to evaluate upstream modular bioprocessing units within the next 12 months.
Future outlook of SUS
The adoption of SUS in the biopharma industry has dramatically increased, especially in response to the demands of the COVID pandemic. These systems have become essential across various stages of production. SUS have been integrated into a wide range of bioprocesses, from upstream operations like mixing and bioreactor
use to downstream processes such as purification and fill-finish.
However, the adoption of SUS is leveling off after the first market penetration. The high cost of disposables is a major concern, especially as manufacturers increasingly weigh the long-term financial implications of using SUS. Although the industry has made strides in addressing earlier concerns such as breakage and the risks associated with leachables and extractables, these issues still linger in the minds of many bioprocessing professionals.
Furthermore, the durability of SUS remains a critical issue, with the potential for bag breakage and the subsequent loss of valuable production material being a significant deterrent. Companies that have invested heavily in traditional equipment may also be reluctant to switch to SUS, particularly when considering the limited scalability of these systems across a broad range of production volumes. The conservative nature of the highly regulated industry further complicates the situation, as any changes to established processes or product lines often require extensive validation studies, regulatory filings and costly testing. This hesitancy to adopt new technologies can slow the pace of SUS integration.
Looking to the future, the continued growth and standardization of SUS will depend on overcoming these challenges. Innovations in material science, recycling and scalability will be essential. Moreover, as automation becomes increasingly integrated into biomanufacturing, SUS will likely evolve to include more automated processes. This shift will not only reduce operational costs but also improve process consistency and product quality.
SUS are also expected to play a critical role in the development and production of advanced therapies, such as cell and gene therapies, that require highly specialized and flexible manufacturing processes.
If SUS systems can continue to evolve and meet the industry’s needs of cost savings, improved profitability and support of complex therapies, they are likely to become fully standardized, ultimately enhancing access to cutting-edge biotherapies and contributing to the broader advancement of biopharma manufacturing.
2 Langer, E.S., et al., 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production., BioPlan Associates. (Rockville, MD, July 2024)., 506 pages.
3 Poll of SUS Suppliers. BioPlan Associates. (July 2024).
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We are no longer strangers to the impact of digital technology. Since the mid-20th century, digitization has had a tremendous impact on the way we consume, exchange, analyze and use information.
Today, another wave of digital transformation is washing over industries across sectors from retail to life sciences in the form of automation and advanced analytics, and it’s enabling efficiencies and growth at an unprecedented scale. In fact, the International Data Corporation (IDC) predicts that 40% of the total revenue for Global 2000 organizations will be generated by digital products, services and experiences by 2026.
For the pharmaceutical industry, adopting digital solutions throughout the value chain can have a profound impact on patients, as it allows companies to rapidly develop and commercialize lifesaving therapies and quickly get them to those who need them most. From streamlining workflows to reducing human errors to uncovering new insights through predictive models that can guide
decision making, there are a plethora of benefits from leaning into next-generation technologies to bridge the gap between teams, across organizations or in a lab full of analytical instruments.
Supporting modern scientists
According to McKinsey Life Science and Data Analytics’ Digital Maturity Index, life science leaders have trailed behind cross-industry leaders in digital adoption, but those that have implemented comprehensive digital solutions saw a 15% bottom line improvement in the following five years.1 As the scientific world continues to rapidly evolve, there is an increased demand for technological solutions that can streamline workflows and accelerate scientific discovery. For organizations looking to revolutionize the way that scientific research is conducted, it is necessary to incorporate digital solutions so that the once-manual laboratory processes can be optimized through data connectivity and automation.
Adopting digital solutions throughout the pharma value chain can be life-changing for patients
MICHAEL ANNINO
For modern scientists, connecting instruments — regardless of vendor — and data is paramount. This connectivity allows for easier knowledge sharing with data flowing from each point in the workflow, and not only does that offer efficiency benefits, but it can enable scientists to rapidly conduct experiments when there is an urgent need to scale up. For example, during the race for a vaccine at the beginning of the COVID-19 pandemic, pharma companies relied on technology transfer to speed vaccines from development to manufacturing to distribution. Since then, pharma companies have been investing in creating interconnected operations to ensure that they can meet an influx of demand.
During global health emergencies and in the day-to-day for pharmaceutical scientists, data is the backbone of drug development. When digital solutions are implemented across organizations, they can connect instruments, reconcile software and integrate lab components that lead to harmonious processes and workflows and enable better data collection for more informed decision making.
When incorporating these solutions, it’s important to consider technologies that can support the entire life cycle of the highly regulated pharma industry, while simultaneously offering the flexibility scientists require to adapt for scientific discovery.
Building the lab of the future
There are several prominent digital technologies that can have a robust impact on highly matrixed pharma organizations and offer additional value when they are incorporated in tandem as building blocks for labs of the future.
Many labs use cloud-based platforms that both centralize data and
incorporate computational systems that can process data for storage and retrieval, such as Laboratory Information Management Systems (LIMS) or electronic lab notebooks (ELN). However, pharma leaders are increasingly turning to technologies that can also help reduce manual tasks, which subsequently lowers the risk of human errors throughout the lab, increases productivity and lowers costs. These technologies include the Internet of Laboratory Things (IoLT), artificial intelligence (AI), machine learning (ML) and automation systems.
Often referred to as smart solutions, AI/ML can be used for holistic lab management, from equipment maintenance or troubleshooting networked systems to guiding decision making with ML algorithms. AL/ML can also be used for predictive analysis in experimentation so that scientists can uncover new ways of interrogating the data and extract the maximum amount of information from their data to propel scientific research. For example, in drug discovery, AI can be incorporated to help scientists identify potential drug candidates which, in turn, allows the scientists to prioritize the most promising drug targets and design their experiments accordingly. In pharma manufacturing workflows, AL/ML can also be instrumental for quality control which can accelerate the development process and speed-to-clinic.
On the more physical equipment side, automated systems, such as robotics, not only improve workflows and experimentation through reproducibility and streamlined sample preparation, but they also enable both novice and experienced scientists to focus more of their time on conducting experiments that advance scientific understanding.
Connecting next-gen technologies throughout the lab creates a comprehensive ecosystem that enables innovation. From increased productivity to maximizing the value of data and improved communication, organizations that institute a digital strategy can reap significant benefits and, ultimately, further scientific discovery.
Accelerating the pace of scientific breakthroughs
Accelerating the drug discovery and development process can play a significant role in making our world healthier and safer. From small molecule drug development to
When digital solutions are implemented across organizations, they can connect instruments, reconcile software and integrate lab components that lead to harmonious processes and workflows.
advanced therapies, the pharma industry can lean on digital technologies to create therapies that improve patient outcomes for hard-to-treat diseases.
When large amounts of data are generated in pharma R&D, scientists can rely on digital tools to help them parse through results quickly and efficiently. For example, advanced technologies and lab automation have been able to accelerate genetic analysis to the point where individual genes can be sequenced quickly and affordably. According to the National Human Genome Research Institute, some genetic sequencing labs can now sequence over 100,000 billion bases per year, and an entire genome can be sequenced for just a few thousand dollars.2 This allows scientists to mass compare DNA sequences, which can provide critical insights about genetic disease traits to inform diagnostic and therapeutic research.
With these novel technologies, scientists can explore new areas of disease research and create innovation at scale. Digitization and lab automation can also contribute to cross-modality studies as we collectively work toward the ability to personalize treatments with precision medicine.
Overcoming challenges of adoption
In the pharma industry, digital transformation can help get lifesaving therapies to patients as quickly as possible. However, according to McKinsey, digital transformations are often more difficult to achieve than traditional change management even though the long-term benefits far outweigh the cost.3 Pharma leaders must rethink operating models across a diverse scope of applications, which poses a challenge to adoption. Regulatory bodies must also assess new methodologies and create guidelines for new technology use while prioritizing safety.
Creating a connected lab can pose both technological challenges and people challenges. In some instances, the existing lab software may prevent the adoption of automated solutions, or the infrastructure prevents scientists from accessing insights across the lab. There are also concerns about maintaining legacy technologies as new solutions come online, and time spent training scientists to use new systems.
The first step in a digital transformation across an organization is to evaluate the current challenges and set goals for creating a connected ecosystem. Pharma companies need to invest in adopting digital and smart solutions to ensure that they can prioritize innovation, reduce R&D costs, streamline end-to-end workflows, speed manufacturing and holistically address patient needs.
Impact of a digital ecosystem
According to Deloitte, there is industry-wide interest in adopting next-generation technologies — from AI to robotics — to help scientists do more science, and organizations are planning digital transformation strategies to create labs of the future.4
Automated science can be transformative for modern research and drug development by enhancing efficiency and throughput, reducing human error and enabling scientists to conduct experiments on an unprecedented scale. Modern scientists need technological solutions that alleviate data silos and extract the maximum amount of value to accelerate the pace of scientific discovery with less time spent analyzing the data and more time spent on experimentation. Digital solutions and automation can also aid in making science more accessible, driving breakthroughs and contributing to the overall success of the industry. As the pharma industry continues to embrace digital transformation, the link between scientists at the bench and a healthier, safer and cleaner world grows stronger. And while there are clear benefits for creating a digital ecosystem, industry leaders must work to overcome the challenges of adoption and strategically collaborate with technology providers to take the first step from scope to implementation.
Investing in lab automation can help digitally-enabled scientists unlock scientific possibilities and advance understanding in a way that will be life-changing for patients.
References
1 Albrecht, B., et. al. Top ten observations from 2022 in life sciences digital and analytics. McKinsey & Co. (Jan. 2023).
2 DNA Sequencing Fact Sheet. National Human Genome Research Institute. (June 2023).
3 de la Boutetière, H., et. al. Unlocking success in digital transformations. McKinsey & Co. (Oct. 2018).
4 Steedman, M., et. al. Forging the links across the value chain. Deloitte Insights. (Oct. 2019).
Chris Darrell
Vice President, IT, Product Development
Manufacturing and Cell Therapy Businesses
Bristol Myers Squibb
Nathan Pettus President, Process Systems and Solutions Emerson
Peter Dam Madsen Senior Vice President, Head of Strategy Business Services FUJIFILM Diosynth Biotechnologies
Accelerating the pharma pipeline is a shared journey
MICHAEL ANNINO SHUTTERSTOCK-AI
A step change in speed to market is possible, but capturing it will require vision, teamwork and standardization
The world has changed since COVID-19, and one of the most significant changes has been a paradigm shift in the approach to developing modern treatments for a much wider array of ailments. As pressure increased to find treatments for COVID, the world and the pharmaceutical industry saw exactly how fast the development pipeline can operate if it was set up for success. While there were societal and regulatory factors unique to the pandemic that made pipeline acceleration possible, innovators are working to adapt technologies and strategies to shorten treatment development timelines.
The result has been a new focus on innovation to dramatically accelerate the pharma pipeline and deliver treatments to patients in need faster than ever. Accomplishing this shift has required developers, manufacturers and automation suppliers to come together in new ways — leveraging software and automation, while simultaneously shifting the internal and external culture around pharma manufacturing. Ultimately, much of that change is aimed at streamlining one of the most time-consuming parts of treatment development: technology transfer.
A key element of speeding technology transfer is rethinking the way teams manage data and scalability across the pipeline. Today’s forward-thinking developers and contract manufacturers are re-examining their business models to build a culture of standardization, leveraging digital systems and new workplace processes to reduce the time it takes to move from research to full-scale commercial manufacturing and distribution.
However, the transition does not stop there. Those same innovators are also working closely together to develop solutions that further reduce bottlenecks and lay the foundation for an even more advanced future of one-click technology transfer.
Trust and technology
This evolving model of drug development and manufacturing is an important approach at the global pharma innovator Bristol Myers Squibb (BMS), as illustrated by the company’s efforts to integrate advanced technologies and build a culture of trust to streamline the technology transfer process. With an increased focus on precision medicine and personalized therapies, BMS is leveraging innovative strategies to accelerate research and development, aiming to bring treatments to patients with unprecedented speed and efficiency.
One such approach is the deployment of Industry 4.0 and 5.0 capabilities, including artificial intelligence (AI) and machine learning (ML). These advanced technologies are utilized for deeper digitalization, data mining, predictive modeling and in silico molecular design. By providing more accurate predictions and insights, AI and ML are transforming the landscape of clinical trials. These tools can enhance the efficiency of technology transfer, ensuring a smooth transition from research to clinical trials, and ultimately, to commercial manufacturing.
Trust is a fundamental component of BMS’ strategy, working hand-inhand with technological advancements. The company has established a continuous testing and improvement environment, designed on a threetiered infrastructure that includes operations and behaviors at the core, business and site levels. Within each tier, changes are rigorously tested and validated through automated tools, helping to ensure accuracy and reliability before deployment. This meticulous process builds confidence across the BMS network, allowing each site to implement updates with assurance of their precision. Such consistency helps prevent errors and deviations in the technology transfer process, enhancing overall efficiency and reducing time to market.
Another cornerstone of BMS’ strategy is digital health integration, driving transformative changes in clinical practices. By placing patients at the center of this evolution, BMS aims to improve patient outcomes through digital technologies. This comprehensive approach ensures that every aspect of BMS’ operations, from research and development to manufacturing and commercialization, is streamlined and efficient. The integration of digital health technologies facilitates real-time monitoring and adjustments, improving the quality and effectiveness of treatments.
Bristol Myers Squibb’s integration of advanced technologies and cultivation of a culture of trust are
Automation controls, like those for the feed tanks pictured, can be standardized across facilities for faster scale-up and scale-out.
pivotal in streamlining the technology transfer process. By leveraging AI, ML, predictive sciences and digital health technologies, BMS is accelerating the development and delivery of new treatments. The company’s commitment to continuous improvement and rigorous testing ensures that technology transfer is not only efficient but also reliable. This holistic strategy is setting a new standard in the pharma industry, ultimately benefiting patients and driving innovation in life sciences.
Contract manufacturers forge ahead
Changes to accommodate an accelerated time to market are not only happening at traditional development and manufacturing companies, but also at contract development and manufacturing organizations.
To better meet the needs of a changing marketplace, biologics contract manufacturer FUJIFILM Diosynth Biotechnologies has shifted its approach to one more targeted to end-to-end life cycle partnerships built around standardization and modularity. The CDMO’s goal is to digitalize and automate everything around the transfer of recipes, and to align the company’s approach through automation so all equipment and automation processes and procedures are standardized across a wide-reaching network of sites.
The FUJIFILM Diosynth Biotechnologies approach is directly focused on accelerating time to market by reducing the time and complexity of technology transfer programs. The more things are the same at each manufacturing site, the easier it is to copy the
automation and setup of a recipe from site to site, even when those sites increase or decrease in scale.
The CDMO is accomplishing this shift by exploring the similarities and differences among customer programs and finding viable and robust ways to align on the variations. This empowers the company to create a more robust standard that also allows for flexibility to accommodate the specific models and processes for a given product.
An example of an opportunity for such standardization can be seen in the antibody manufacturing process. Many companies perform nearly the same process, with only a few variations that have evolved as they invented their own solutions. Many of those variants can be either designed as options in a process or standardized out of the process. The benefit of following FUJIFILM Diosynth Biotechnologies’ recommendations for standardization is the capability to use a system of near-seamless scalability and global reach from the earliest moments of production.
Consider a product manufactured in a uniquely designed 2k bioreactor facility. If demand skyrockets and the manufacturing must be moved to a 10k or 20k facility, the product will be subject to many delays and complexities, and the technology transfer steps will have to be reperformed with each change. In contrast, a product designed around FUJIFILM Diosynth Biotechnologies’ standardized ecosystem can be replicated quickly and easily in any size facility to expand output and reach.
Moreover, such a configuration can be represented in a joint master file and submitted to regulatory authorities so the product can potentially be pre-approved for manufacture from various nodes of the CDMO’s standardized global network — reducing or eliminating the need to re-perform technology transfer with every change.
This new paradigm of operation and partnership empowers pharma companies to unlock increased speed to market through better planning from the earliest stages of development. At the beginning of a new project, partners can provide their portfolio data and share their projections, expectations and needs, working closely with FUJIFILM Diosynth Biotechnologies to see how those projections can be met by scheduling capacity and capability on the existing infrastructure. Instead of
FUJIFILM
working from a request for proposal with no context, the CDMO can help companies identify next steps and prepare for the needs that materialize beyond the immediate, eliminating bottlenecks and unlocking the flexibility and accessibility necessary to shorten manufacturing timelines, even while navigating change.
Automation at the core
As drug developers and contract manufacturers evolve their pipelines to accelerate speed to market, both rely on a powerful automation layer to accomplish the necessary changes, and to reduce or eliminate deviations. As a result, automation suppliers are evolving their technology alongside pharma organizations to provide a faster pipeline for people in need of new therapies.
First and foremost, automation suppliers are helping pharma manufacturers digitalize. Paper records are not conducive to a streamlined, fast-moving development and manufacturing environment, but neither is a wide diaspora of digital solutions that are not seamlessly integrated. Today’s manufacturers must manage a vast array of factors, including version control, maintaining the link between a recipe and its parameters, identifying where a treatment is in the pipeline, monitoring change and more. Moreover, all those elements must be translated into recipes a manufacturer can use, so it is critical to make the technology transfer process more seamless.
One critical element of this transition is new tools, such as process and knowledge management (PKM) software, to close the gap more effectively in technology transfer. PKM software can electronically capture every recipe decision made across the development pipeline, ensuring it is standardized and accurate, as well as
automatically manage calculations for easier scale-up across different stages.
Forward-thinking organizations are also implementing technologies like process analytical technology (PAT) in their automation infrastructure to leverage in-line, continuous, closedloop process verification and control. Armed with quality information in real time, teams can more easily avoid deviations, and potentially unlock real-time quality release for increased speed to market.
However, currently available software solutions cannot engineer all the complexity out of technology transfer. That is why key stakeholders in the pharma industry — across automation, research and development, manufacturing and more — are coming together to build a one-click technology transfer framework to align on a set of standards for centralized transport and translation of data. Their goal is to integrate the technology transfer process, creating a holistic product platform for management, sharing and translation of data, using open source and open standards to align on the best way to translate recipes into automation systems.
Automation suppliers are also working hard to improve flexible manufacturing capabilities, designing new software solutions that are easily and seamlessly reconfigurable. These solutions require a move away from traditional automation engineering, where processes are designed around static models, set up once, and then run for years or decades with few changes.
Next generation automation systems will instead follow manufacturers’ new needs. Such solutions might be designed with the capability to build varying, modular plant models, and to then adjust them as needed. Or some automation systems may expand parameterization to include equipment
in addition to ingredients. Ultimately, these types of solutions will allow users to change processes, recipes and equipment as needed, while simultaneously maintaining an accurate audit trail to historize what has been done, paving the path for faster regulatory approval, even as options for configuration expand exponentially.
Navigating the paradigm shift
The need to bring new treatments to patients quickly and safely is nothing new. Pharma organizations have been improving their processes for decades and have continuously achieved incremental gains. What has changed is that manufacturers have begun to make massive shifts in their capability to develop more standardized, modular processes that will lead to a step-change that was not previously possible.
As both science and technology innovations evolve, pharma organizations have the tools to build a new roadmap for the future. That new roadmap typically moves away from blockbuster drug production over decades and instead favors flexible capabilities to quickly adjust for new discoveries, needs and market factors. However, no single organization can accomplish that goal alone. Instead, developers, manufacturers and automation suppliers will all need to work together to help build a new manufacturing future founded in open standards, seamless integration and data mobility from end to end.
The key players are already coming together to make this new paradigm a reality, and there is room for input from organizations just beginning to shift their strategies to increase their speed to market. For those interested in shaping the future of the treatment pipeline, there has never been a better time to get in the game.
Dave DiProspero Senior Fellow, Pharma Process
JT Cochran Senior Process Engineer
Dry powders are an integral component of many pharma products manufactured under CGMP operations. In addition to OSD, powders are frequently used in the manufacturing of aseptic products, including mAbs, vaccines, and cell and gene therapies.
Safe handling of dry powders is an absolute must in all manufacturing operations. Pharma companies need to ensure that both operators and facilities are appropriately protected against the hazards that are present.
The list of items to consider when handling and processing powders is lengthy and requires significant evaluation and implementation of engineering controls, but there are three key items on which pharma can focus.
Dust control and containment
One of the biggest challenges faced with powders is dust generation. Per code, a hazard can occur when one or both of these conditions are present: significant accumulation of powders on horizontal surfaces (the original surface color can’t be discerned) or a high concentration of powder particulates suspended in air.
There are many ways to mitigate dust generation and keep fugitive dust emissions to a minimum, including implementing closed operations using mechanical connections between powder transfer containers or using dust collection equipment with dust collection pickups that can be localized. Implementing equipment design features that remove the sources of ignition or oxygen, and contain/safe
Preventing dry powder hazards
Pharma manufacturers must design facilities and processes for safe handling
direct explosions can significantly impact equipment installation and cost.
A facility built for handling powders must also include design features that minimize hazards. This may require implementation of electrically classified zones or containment of an explosion, all of which will impact cost, construction and scheduling for both new and existing facilities.
Ergonomics and safe handling
Dry powders are delivered from the raw materials supplier in a wide range of container types. Unfortunately, there is no industry standardization and handling systems will need to accommodate drums, bags, supersacks and small containers and boxes.
From a process design standpoint, it’s important to implement the necessary equipment and technology to handle all container types. Know bulk density ranges and incorporate automated/semi-automated lifting devices to offer ergonomic assistance. Apply the appropriate levels of PPE. Evaluate and understand the flowability of the materials being handled.
From a facility design standpoint, consider all locations where powders will be opened and transferred from their source containers to the process. Be sure to provide adequate room space and height, with gravity as the preferred method of transfer. Consider a dedicated weigh/dispense area where incoming raw materials can be weighed and subdivided to accurate downstream batching and processing
requirements. The use of common transfer containers, such as IBCs or single-use bags, is a good way to handle process feed standardization.
Combustibility
While the hazards that exist when dealing with flammable liquids arestraightforward, this isn’t always established with combustible dusts. While code provides an easy to implement definition of flammable liquids by flash point and boiling point, this is not the case when classifying combustible dusts. The most quantifiable method for determining the level of combustibility of powders is through third-party testing, which will provide all the data needed to do a thorough evaluation of the hazard level.
The next step is to perform a dust hazard analysis (DHA), which is a systematic review of all operations that utilize powders to determine where and under what conditions hazards exist and identify necessary mitigations. In North America, a DHA is a code requirement and may need to be submitted to local authorities as part of a facility permitting process.
A DHA goes beyond immediate capital project needs and defines requirements for long-term operations, like procedural measures for ensuring hazards are mitigated over the life of the facility.
This comprehensive approach to handling dry powders is critical to protecting pharmaceutical operators and facilities.
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