HOW CLOUD TECHNOLOGIES SUPPORT THE EVOLUTION OF BIOPHARMA MANUFACTURING

Through cloud-based solutions, outsourcing/ partnership models can be designed to share scientific and process information by merging collective expertise from both the innovator and the CDMO.

Outsourcing biopharmaceutical manufacturing was already a growing trend before the pandemic, and now the biologics contract development and manufacturing (CDMO) market is projected to grow at 12.2% from 2021-2026. The forecast is even higher for cell and gene therapies (CGT), where the current level of outsourcing is more than 60% and the CGT CDMO market is expected to grow at 25% annually. While there are many economic factors driving this growth, one clear outcome is that cloud computing is quickly becoming a key enabling technology.

Cloud solutions support the need for more effective collaboration across an increasingly complex network of external partners and suppliers. While skills and capacity shortages, particularly for advanced therapies like CGTs, can make in-house manufacturing seem a worthwhile investment, most small biotechs don’t have the budget to afford it without support from big pharmas. The idea of outsourcing can raise concerns around loss of control, but outsourcing doesn’t have to mean handing the project entirely over to external partners. Through cloudbased solutions, outsourcing/ partnership models can be designed to share scientific and process information by merging collective expertise from both the innovator and the CDMO.

The importance of data visibility and transparency in this context cannot be overstated. CDMOs need a scientific understanding of the product, while innovators need insight into process steps, process controls, and even raw materials. If this data can be digitised with appropriate context from the start, the entire lifecycle becomes more efficient and streamlined, leading to faster time to market. Cloud-based systems provide an attractive entry point for small biotechs as they don’t require investment in IT infrastructure yet still provide the ability to scale up, as business needs change such as recruitment of new employees. For CDMOs, the right digital architecture can ensure high availability for their clients with appropriate data access controls while moving towards real-time monitoring and predictive analytics, such as machine learning.

Cloud solutions make communication between

CDMOs and innovators more seamless. It is common for new therapeutics to be developed at one site and produced in another, or for the same product to be produced in multiple locations across the globe. For an innovator, gaining insight into process performance at different sites used to require flying technicians and experts over for physical inspections. Now, with augmented reality (AR) technologies, inspections can be conducted remotely. Cloud solutions enable sideby-side comparison across sites, providing a holistic view that supports more fluid collaboration across teams.

The good news is that enabling cloud solutions are available today. However, the lack of data standardisation and common terminology for bioprocesses remains an obstacle. While many big pharma companies have attempted to create their own data standards to address this, there is still a lack of consensus across the industry which can lead to data discrepancies when multiple groups are involved. The silver lining is that increased data visibility and data sharing is creating urgency around this issue. Industry consortia, such as BioPhorum, are actively working to address this common challenge.

It’s time for small biotechs, big pharmas, CDMOs, and other players in the biopharma network to think differently about their data, and the value it can provide. Cloud-based solutions are here to stay.

APPLICATIONS OF mRNA VACCINES: FROM THE 1990s TO TODAY

Although mRNA-based vaccines came to the forefront with SARS-CoV-2, they have a much more deep-rooted history. Pioneering research was conducted in the early 1990s when scientists realised that synthetic mRNA could induce the expression of a foreign protein and prompt antibody production by the immune system. Influenza was the first disease tackled by mRNA vaccines, and efficacy was shown when injections induced cytotoxic T-cell response in mice. While its preventative potential was still being explored, other studies focused on cancer, with researchers theorising that injection could prompt the body’s natural defence system to attack tumour-associated antigens.

Several clinical trials involving mRNA-based vaccines were already in the works before the COVID-19 pandemic boosted their visibility. These included phase I and II clinical trials for ovarian cancer, multiple myeloma, brain cancer, acute myeloid leukaemia, lung cancer, zika virus, parainfluenza virus, and rabies. In addition, mRNA vaccines are currently being tailored to unlock personalised cancer treatment through patient-specific targeting strategies.

As the number of cases and casualties from COVID-19 exponentially increased, pharmaceutical companies turned to mRNA while racing against time to deliver an efficient preventative treatment. Scientists demonstrated that laboratory-engineered mRNA instructed muscle cells to produce the spike protein found on the virus surface,