BNN QUARTERLY - 03/2024

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BioNanoNet Forschungsgesellschaft mbH

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Editorial

TAKING SUSTAINABLE STEPS FOR A HEALTHIER FUTURE

During this year’s BioNanoNet Annual Forum, our keynote speakers drew special attention to the challenges that the pharmaceutical sector is facing, from surges in demand to drug shortages to regulation, that urgently need to be addressed by all stakeholders involved to ensure this sector remains competitive in the future.

The pharmaceutical industry is undergoing a profound transformation. As the world faces increasingly urgent environmental challenges, the pharmaceutical sector is compelled to adopt more sustainable practices in both drug development and manufacturing processes – not an easy feat due to the complexity of the sector. The Annual Forum emphasized the intersection of innovation, regulation and sustainability, positioning the industry at a pivotal moment in its evolution. It underscored the fact that sustainability in pharmaceuticals is an ethical consideration as well as a strategic imperative.

A key takeaway of the Annual Forum was that sustainable pharmaceutical development should be integrated into every stage of the life cycle of the sector. This means embracing green chemistry, reducing the use of harmful solvents and chemicals, adopting circular economy principles, and ensuring that waste and emissions are minimized. BNN’s offer to support innovative development in order to comply with sustainability aspects can help meet these needs.

Our 5 support areas – Go Compliant – Go Sustainable – Go Smarter – Go to Market – Go Beyond – offer holistic expertise for biotech and pharma companies (among others) looking to improve sustainability along the whole innovation process, from design to market.

This issue, “Moving Toward Sustainability in the Pharmaceutical Sector,” dedicates a series of articles to this essential topic, underscoring the steps toward sustainability taken by many of the BioNanoNet Association members. Looking ahead, the pharmaceutical sector must continue to innovate and push boundaries in order to make sustainability the norm rather than the exception. We are at a crossroads where every decision impacts the future, and it is imperative that we choose sustainability at every turn. It is BNN’s mission to support you on this endeavour!

Sincerely,

Andreas Falk, CEO

BNN NEWS

New BioNanoNet Association Members

AIRI – Associazione Italiana Per La Ricerca Industriale

Extraordinary Member, Italy

AIRI is a non-profit private organization, funded in 1974. Its mission is to promote industrial Research and Innovation and co-operation between the private and public sectors, as well as sustainable growth. AIRI members are large industrial enterprises and SMEs, universities, public research institutions, technology clusters and financial organizations. Due to its broad representative base, AIRI is acknowledged as a key opinion leader in Technology forecasting and Research-policy design. Themes of interest include public-private cooperation, technology assessment, monitoring and analysis of R&I policies and incentives and norms and standards, promotion of STEM training and education, dissemination and communication of science and technology activities.

Visit AIRI’s website

OCSiAI Europe S.a.r.l

Extraordinary Member, Luxembourg

OCSiAl is the world’s largest producer of graphene nanotubes. In addition to the synthesis of nanotubes themselves, they create industryfriendly technologies for their use in various materials. Their team consists of more than 200 employees located in Europe, the Americas and Asia.

Visit OCSiAL’s website

PHORNANO Holding GmbH

Standard Member, Austria

PHORNANO strives to lead in the invention, development and manufacture of the most advanced nanomaterials and devices. They translate these advanced technologies into value for the customers/users through their solution, service and consulting business worldwide.

Visit PHORNANO’s website

Silicon Austria Labs GmbH (SAL)

Standard Member, Austria

Silicon Austria Labs develops technologies for a greener, smarter and more connected future of Electronics and Software Based Systems (ESBS). At three locations (Graz, Villach, Linz), more than 300 employees are working on future-oriented solutions for industrial production, health, energy, mobility, safety and more.

Visit Silicon Austria Labs’ website

New Publication on the Governance of Advanced Materials: A Call for Sustainable Development

Advanced materials pose a challenge in terms of governance of risk and sustainability. However, we do not have to start from scratch. A new paper transfers lessons learned from risk and sustainability governance of nanomaterials to the domain of advanced materials.

This publication is an essential read for policymakers, scientists and industries that are navigating the complexities of cutting-edge materials.

In a rapidly evolving world of technological advancements, the governance of materials is crucial to ensure their safe and sustainable use. "Governance of Advanced Materials: Shaping a Safe and Sustainable Future" has been published in NanoImpact , addressing the growing need for robust frameworks to manage risks related to advanced materials, such as nanomaterials and other emerging technologies.

This research leverages decades of lessons learned from managing nanomaterial risks and offers a strategic blueprint for future governance. It highlights key knowledge gaps, evaluates existing tools, and suggests novel actions to improve risk management and sustainability practices. As the use of advanced materials increases across industries, this paper emphasizes the importance of proactive policies and collaboration between stakeholders, from regulators to innovators, ensuring that these materials benefit society while minimizing environmental and health impacts.

By providing a pathway to improving governance mechanisms, this publication is an es -

sential read for policymakers, scientists, and industries that are navigating the complexities of cutting-edge materials. It represents a crucial step toward fostering innovation while safeguarding both human health and the environment. In a nutshell, its key findings are:

 The history of nanotechnology risk governance is useful for Advanced Materials.

 Coordination of research streamlines knowledge transfer from science to regulation.

 Safe and sustainable innovation approaches are essential for Advanced Materials.

 Multistakeholder engagement improves trust in risk decision-making.

 Governance of Advanced Materials needs a central organization structure.

From BNN, Susanne Resch contributed to this publication based on her work as WP leader in

the H2020 NMBP-13 project Gov4Nano. Several BioNanoNet members co-authored the paper, namely the Italian Association for Industrial Research (AIRI), the Luxembourg Institute of Science and Technology (LIST) and the research group for nanobiology and nanotoxicology at biotechnical faculty of the University of Ljubljana. Read the full article here

This work was supported by the European Union’s Horizon 2020 Research and Innovation Programme under Grant Agreements No. 814401 (Gov4Nano), 814425 (RiskGONE) and 814530 (NANORIGO); by OECD Grant Agreement 887268 (NANOMET) and by the Dutch Ministry of Infrastructure and Water Management.

Contact

Susanne Resch susanne.resch@bnn.at

Mapping the R&D&I Landscape of Nanomedicine in Austria: Your Insights Matter!

At NanoMedicine-Austria, we are dedicated to advancing nanomedicine by bringing together bio- and nanomedical experts. Our goal is to increase the visibility of nanomedicine in Austria as a benchmark for research and innovation, promoting both basic and applied research to strengthen the transition from laboratory breakthroughs to clinical applications.

To achieve this, we need your input. We invite you to participate in a brief online survey designed to provide us with an overview of the current progress, challenges, and opportunities in nanomedicine within Austria. Your insights will help shape the future of research and collaboration in this field.

Why your participation matters:

 Identify key areas: Help us pinpoint where future research and collaboration should focus.

 Understand current expertise and needs: Share details about your latest publications, ongoing projects, and infrastructure needs.

 Guide innovation in the right direction: Provide insights on challenges you face.

 Get involved: Let us know if you're interested in participating in NanoMedicineAustria's activities, such as contributing to relevant strategic documents, or participating in networking and education events.

The survey should take 5 to 10 minutes and offers a chance to share your focus in nanomedicine, the role of nanotechnology in your work, and more.

Ready to contribute?

Click here to access the survey . We greatly appreciate your time and valuable insights.

The survey is developed by NanoMedicineAustria, for more information about the platform please visit the website .

Contact Susanne Resch office@nanomedicine-austria.at

Julia Voglhuber-Höller Invited as Panelist for Career Symposium at Medical University of Graz

What can I be with a PhD?” This was the question posed to graduates of the Medical University of Graz (MUG) who have transitioned to careers outside academia, at the Annual Career Symposium on 5 July in Graz. As a PhD-graduate from the doctoral program “Molecular Medicine” at MUG, BNN´s Julia Voglhuber-Höller was invited to speak about her career path as a panelist.

Around 80 PhD students and freshly graduated Post Docs gathered in the Aula to get a glimpse into career options within and outside of academia, in several dedicated sessions. Julia had the chance to introduce BNN and the projects she is working on at this event, but also to talk about her assigned responsibilities and tasks in her current job as a scientific researcher working on Safe-and-Sustainableby-Design concepts. The students were par-

ticularly interested in the required soft skills relevant for such a position, and what are the overlaps and differences to working as a university assistant during one´s PhD studies. After the panel session, each panelist was assigned a breakout room, offering the possibility for more informal discussions between panelists and students.

Overall, this event was a great opportunity for PhDs in life science to get a better overview of their career options, but also for BNN to raise awareness for our association and goals among the new generation of scientists.

Contact

Julia Voglhuber-Höller julia.voglhuber-hoeller@bnn.at

Panelists from the left: Stefanie Duller (Pfizer), Julia Voglhuber-Höller (BNN) and Shirin Sharghi (Scantox Neuro Gmbh)

Webinar “Building the Foundation: Interlaboratory Comparisons and Reference Products for Advanced Materials”

The development of advanced materials with improved functionalities is necessary to drive the economic development and address the major challenges of the coming years in a variety of fields, such as energy, mobility, construction, and electronics. Typical examples of such advanced materials are nanomaterials, 2D materials, or thin films. The development of these materials should be accompanied by the development of reliable measurement methods to understand the performance of the materials and to ensure their acceptance in various sectors as safe and sustainable for both humans and the environment. To ensure the reliability of the characterization of advanced materials the use of reference methods, materials, and data is suggested.

The development of reference products and the importance of interlaboratory compari -

sons (ILCs) were presented in a webinar “Building the Foundation: Interlaboratory Comparisons and Reference Products for Advanced Materials” on 16 May 2024, organized by the BAM Academy in cooperation with the Surface and Thin Film Analysis Division and supported by the Graphene Flagship and INISS-nano (International Network Initiative on Safe and Sustainable Nanotechnologies). More than 60 people attended.

After a short introduction about ILCs and the Versailles Project on Advanced Materials and Standards (VAMAS) as a platform for their realization, Dan Hodoroaba (BAM), Korinna Altmann (BAM) and Alessio Sacco (INRiM) presented some examples of ILCs. The focus of these ILCs was on graphene, nanomaterials and microplastics, which were examined using different methods, such as electron microscopy and Raman spectroscopy. Vikram Kes -

tens (European Commission - Joint Research Centre) explained how ILCs are used for the development of reference materials in nanotechnology. The importance of the metrological traceability was emphasized by Thomas Linsinger (European Commission - Joint Research Centre). Accurate results must be traceable to the SI units. The different reference products provided by BAM and their potential use was presented by Silke Richter (BAM). The Knowledge infrastructure including protocols and data was presented by Barry Hardy from the Swiss company Edelweiss Connect. Amaia Zurutuza from the Spanish graphene producer Graphenea pointed out the importance of reference products and ILCs for small and medium enterprises.

All participants made it clear that the development of reference products for advanced materials will be a necessity in the coming year for their trade along the product chain and their acceptance by users, consumers and society as a whole.

Contact

Bundesanstalt für Materialforschung und –prüfung (BAM) Jörg Radnik joerg.radnik@bam.de www.bam.de

ETPN 2024 in Milan:

Shaping the Future of Nanomedicine

The European Technology Platform on Nanomedicine (ETPN) organized ETPN 2024 from 10-12 June in Milan, Italy, bringing together European leaders in R&D&I in nanomedicine. This year’s event focused on the latest advancements in nanotechnology-driven healthcare, with keynote speeches from Prof. ssa Cristina Messa, Scientific Director of Fondazione Don Gnocchi, who highlighted the translation of nanomedicine into clinical practice, and Prof. Elena Cattaneo of the University of Milano, known for her groundbreaking work on Huntington’s disease.

The conference provided a comprehensive platform to discuss innovations across diagnostics, drug delivery, and personalized therapies, attracting more than 150 participants from academia, industry, and healthcare sec-

tors. Sessions covered topics like regenerative medicine, nano-imaging, and the future of cancer treatment through nanoparticle therapies.

A notable feature of the event was its Innovation Showcase, where startups and researchers exhibited cutting-edge technologies aimed at reshaping global healthcare. Attendees were introduced to a range of groundbreaking applications, from advanced biosensors for early disease detection to nanoparticle-based vaccines.

This year’s theme, "Pioneering Nanomedicine for a Healthier Tomorrow," emphasized both the technical and societal impacts of nanomedicine, as experts delved into the ethical challenges and policy frameworks needed to bring these innovations to clinical settings. A dedicated workshop explored regulatory chal -

lenges, while networking sessions encouraged new collaborations across organizations and disciplines.

The event also provided a great opportunity to connect national technology platforms on nanomedicine with the European ecosystem. Susanne Resch, BNN scientific researcher and coordinator of the NanoMedicine-Austria platform, took part in the event and exchanged ideas with other national platform coordinators from Italy and France. Next to that, she contributed a poster and oral presentation on “PHOENIX-OITB – Developing and upgrading innovative nanopharmaceuticals from bench

to clinics”, in which she presented the unique Open Innovation Test Bed for nanopharmaceuticals and its activities. Next year, ETPN will celebrate its 20th anniversary during the NanoMedicine Europe 2025 conference in Barcelona from 27-30 May 2025. We are looking forward to the anniversary celebrations as part of this scientific conference and encourage our members to save the dates!

Contact Susanne Resch susanne.resch@bnn.at

PHOENIX project has received funding from the European Union’s Horizon 2020 research and Innovation programme under grant agreement n° 953110.

Susanne Resch presenting her poster on PHOENIX-OITB

BNN at MaterialsWeek 2024

MaterialsWeek 2024 took place 17-21 June 2024 in sunny Limassol, Cyprus. The event aimed to bring together Research and Innovation (R&I) communities that are driving advances in materials innovation manifested across diverse value chains and industrial markets.

By addressing all materials application sectors and R&I communities concerned with the (re-)discovery, identification, improvement, handling, processing, manufacturing, (re-)use and recycling of materials, the event provided a cross-disciplinary meeting venue for communication and collaboration over and beyond traditional community boundaries.

The conference was organized by several EUfunded projects dealing with advanced materials and Safe-and-Sustainable-by-Design. It was a valuable opportunity to strengthen collaboration with the community by combining insights, theories, and methods from different fields to address complex issues. In addition, the meeting emphasized the fluidity of disci -

plinary boundaries and encouraged the free flow of ideas and methods between different fields. This convergence ultimately aimed to foster the best joint R&I approaches for meeting today’s challenges and innovation requirements, including, but not limited to, more sustainability, circularity and resilience in materials’ uses, higher reliability and efficiency in both R&I and sustainability assessment and safety testing of materials.

The MaterialsWeek 2024 highlighted and addressed all relevant R&I aspects along different materials innovation chains, including from up-stream pre-competitive basic research to end-of-life, highlighting and elaborating solutions to the challenges arising in the context of the overarching policies (e.g., the EU Green Deal, Chemical Strategy for Sustainability, Chips Act, Circular Economy Action Plan, Bioeconomy Strategy, Critical Raw Material Act, to name but a few), and their targets (e.g., the United Nations Sustainable Development Goals (SDGs), decarbonization).

from the left: Wouter Fransman (TNO), Blanca Suarez (Temasol) and Susanne Resch (BNN)

The well-run event provided an opportunity for materials scientists working in various fields to meet in person, exchange opinions, and present their perspectives on the issues of safety and sustainability in the design of advanced chemicals and materials. Scientists working on different projects but within similar case studies (e.g., energy, mobility, construction, electronics, textiles, health, cosmetics, automotive) met and discussed how collaboration on these projects can enhance the development of next-generation materials that meet safety and sustainability criteria.

One of the major achievements of the conference was the development of a continuously expanding network of materials scientists who can pool their expertise and tools for a common purpose. They also learnt about methodologies and tools previously unknown to them, which can be used in conjunction with their own.

The MaterialsWeek 2024 overall program is available here , as well as a detailed agenda here . The Book of Abstracts is available here .

Our colleague Susanne Resch attended the conference representing activities of different projects BNN is involved in (HARMLESS, DIAGONAL, SSbD4CheM, IRISS, PARC, AdMa4Med), as well as clusters we heavily collaborate with (e.g., the EU NSC). “I enjoyed discussing the progress of advanced materials in different industrial markets with international experts, and how Safe-and-Sustainable-byDesign can support to meet current and future innovation requirements”, Susanne said. In addition, she presented her work on “Navigating challenges: the use of advanced materials in medical devices” with a poster and a 24/7 pitch presentation. It was a great conference and nice to meet many BioNanoNet members, project colleagues and new collaborators!

Contact Susanne Resch susanne.resch@bnn.at

The AdMa4Med project is supported by the Federal Ministry of the Republic of Austria for Climate Action, Environment, Energy, Mobility, Innovation and Technology (BMK), serving as the funding body, with the FFG acting as an intermediary.

These projects have received funding from the European Union’s HORIZON 2020 research and innovation programme under grant agreement n° 953152 (DIAGONAL), n° 953183 (HARMLESS) and European Union’s HORIZON EUROPE research and innovation programme under grant agreement n° 101058245 (IRISS) and n° 101057014 (PARC) and n° 101138475 (SSbD4Chem).

Susanne Resch from BNN in front of her poster

Challenges of Implementing SSbD in the Nanomedical Field at Summer School

BNN contributed to the “10th S3C Summer School on Sustainable Chemistry for Sustainable Development”, organized by the Leuphana University, ISC3 and the IRISS EUfunded project, with a lecture about “Challenges of implementing SSbD in the Nanomedical field”.

The summer school took place 8-12 July in the campus of the Leuphana University, in Lüneburg (Germany) and consisted of three full days of exciting keynote lectures, all of them related to the concept of SSbD and its implementation in different sectors.

Many participants, all coming from different backgrounds and experience levels, contributed to a great atmosphere of fruitful discussions and collaborations around different topics.

The sessions covered the concept of sustainable chemistry during the first day, Safe-andSustainable-by-Design, Circular Economy as well as “SSbD in Nanomedicine” during the second day. Hands-on workshops with the students took place on the third day, covering topics such as “SSbD practice applied in your company”, “SSbD Roadmapping for a given sector” and “Practical case examples and exercises with the SSbD toolbox”.

In the frame of the second day, BNN gave a keynote providing insights on the challenges the nanomedicine sector has with implementing SSbD. The presentation began with setting the scene, providing definitions for Nanomedicines & Advanced Materials, as well as providing an overview about the evolution of

Participants of the 10th Summer School on Sustainable Chemistry for Sustainable Development

the Nanomedicine field, since the 1960s. The keynote followed the whole innovation process in the nanomedical field, highlighting the particularities of the field. It included also a walk along the process of clinical translation and the process of development of therapeutic nanomedicines. This extensive first part of the talk was complemented with the JRC – SSbD framework, its steps and dimensions, and how they correlate with and particularities of them when applied to the nanomedical field. The talk finished with future prospects in the field as well as highlighting of the general challenges in the field to overcome.

Role of BNN in IRISS

Communication, Dissemination & Consultation support, Mapping of SSbD methods & criteria, Definition & Testing of services

Contact

Johanna Scheper johanna.scheper@bnn.at

IRISS project has received funding from the European Union’s HORIZON EUROPE research and innovation programme under grant agreement n° 101058245. UK participants in Project IRISS are supported by UKRI grant 10038816. CH participants in Project IRISS receive funding from the Swiss State Secretariat for Education, Research, and Innovation (SERI)

Lecturers at the 10th S3C Summer School on Sustainable Chemistry for Sustainable Development from the IRISS project.

FOCUS TOPIC

Speakers of the BioNanoNet Annual Forum

BioNanoNet Annual Forum & Joint Networking Session 2024 on “Sustainability in Pharma” was a great success

On 12 September 2024, our community braved the rain to gather in the beautiful Aula of the Graz University of Technology for a memorable event. The BioNanoNet Annual Forum on “Sustainability in Pharma” was a satellite event of the ECCPM Forum (European Consortium for Continuous Pharmaceutical Manufacturing), hosted by BioNanoNet Association member RCPE (Research Center for Pharmaceutical Engineering), which took place from 11-12 September.

The Annual Forum was followed by the BNN Networking Event, this year held as a joint event with RCPE and the cluster Human.technology Styria.

To launch the event, we had the pleasure of hearing keynote speaker Michael Mayr, General Manager of Fresenius Kabi Austria GmbH, on the topic “Impact of a Potential PFAS-Ban on the Pharmaceutical Industry”. In his engaging speech, he gave the example of Propofol, the most common drug for inducing anaesthesia (and which was essential during the COVID-19 pandemic for ICU patients), which is manufactured by Fresenius Kabi. He explained the impact of a potential PFAS-ban on the production of Propofol, which would lead to a major drug shortage due to long R&D and production timelines. He encouraged the community to think more expansively about solutions for environmental issues without causing shortages of essential drugs. In the end, he called on the public as well as industry and research groups to contribute, as “innovation is the only solution”.

The second keynote was given by our BNN colleague Johanna K. Scheper, who explained how companies can benefit from thinking about safety and sustainability from the beginning of the design phase all the way to the market, and the innovation support that BNN can provide.

Next there was a panel discussion focusing on the relevance of sustainability in the pharmaceutical industry. Pharmaceutical experts Hans Christian Eder of ZETA GmbH and Cornelia Haas of VTU Group shared their insights and perspectives with BNN CEO Andreas Falk.

Participants were able to book individual consultations with Ines Haberl from the Austrian Research Promotion Agency, National Contact Point for Health, which took place after the session.

This exciting event ended with a friendly gettogether over a traditional Austrian buffet and drinks.

We were pleased to welcome so many of you to our event and are looking forward to the next BioNanoNet Annual Forum & BNN Networking Session next September 2025!

The BioNanoNet Annual Forum concluded with the session “Future Collaborations”. Ines Haberl from FFG Austrian Research Promotion Agency gave an overview of European Funding Opportunities for Health Research, stressing that the 100% funding rate in Horizon Europe is unique. Then Lejla Pock, CEO of Human. technology Styria GmbH, explained how HTS provides support within the region, including a fund for projects in sustainability, which she urged participants to consider. Finally, Astrid Kaltenböck, Managing Director at EIT Health Austria, gave insights into the many initiatives and educational programs and think tanks of the EIT network.

Impressions of the event

PHOENIX Webinar: A New Player Bridging Nano-Pharmaceutical Innovation from Design to Clinic

To end a week of dynamic activities in the pharma sector, many members of our community took place in a webinar on 13 September. “PHOENIX: A new player bridging nanopharmaceutical innovation from design to clinic” introduced interested SMEs, startups and researchers to the Open Innovation Test Bed (OITB) for nanopharmaceutical development.

PHOENIX-OITB is a project funded by the EU to offer a consolidated network of facilities, technologies, services and expertise for all the technology transfer aspects from charac-

terisation, testing, verification up to scale up, GMP compliant manufacturing and regulatory guidance.

Services were presented within the following categories:

 Physico-Chemical Characterisation (Jesus M. de la Fuente, CSIC)

 In vitro Characterisation (Tommaso Serchi, LIST)

 In vivo Characterisation (Ivana Vinkovic Vrcek, IMROH)

 Manufacturing

(Alba Cordoba, NANOMOL Technologies)

 Innovation (including regulatory aspects) (Daniel Garcia, BNN)

To launch the webinar, project coordinator Tommaso Serchi (LIST) introduced PHOENIX-OITB, its aims and organization. Then Johannes Khinast (RCPE) explained the role of continuous manufacturing to improve nanopharmaceutical production. Next, Jesus M. de la Fuente (CSIC) gave a detailed overview of the services provided by the partners of the OITB and the Single Entry Point, founded as PHOENIX SEP in late 2023.

Finally, the experts from each of the 5 service areas joined a “roundtable” discussion moderated by Caitlin Ahern (BNN). Here they were asked questions specific to their services to help participants better understand what PHOENIX can offer them, and what the customer experience would look like.

Interested participants were encouraged to contact scientific coordinator and CEO of the PHOENIX Single Entry Point (SEP), Dr. Nazende Günday-Türeli, to set up an initial meeting.

Thanks to all who joined us!

Role of BNN in PHOENIX

BNN contributes to tasks in business development and overall sustainability of the project and the future OITB. These activities are performed in close collaboration with the “marketing” (communication & dissemination) work package, in which BNN has the lead role, dedicated to dissemination and exploitation activities for marketing purposes and establishing connections with stakeholders during the project.

Contact

Dr. Nazende Günday-Türeli info@phoenix-sep.com www.phoenix-sep.com

PHOENIX project has received funding from the European Union’s Horizon 2020 research and Innovation programme under grant agreement n° 953110.

Interview: BNN provides regulatory expertise to biotech company Aromics

In the past year, BNN has expanded its innovation portfolio to include expertise in strategic regulatory affairs. We are pleased to put this expertise into practice in projects and consultations with companies. As a strategic partner offering comprehensive regulatory support along the entire development pipeline for the biotech company AROMICS (Applied Research using OMIC Sciences, S.L.), BNN’s

regulatory specialist Daniel Garcia sat down with AROMICS CEO Carme Plasencia in Barcelona to reflect on the experience thus far.

Daniel Garcia: Carme, can you briefly introduce AROMICS and yourself, as CEO of the company?

Carme Plasencia: AROMICS is a biotech company specializing in the development of in -

Daniel Garcia from BNN interviewing Carme Plasencia from AROMICS

novative therapies for cancer and other serious diseases. Leveraging a unique pipeline of molecules targeting RNA, AROMICS aims to address unmet medical needs by developing precision medicines with greater specificity and fewer side effects than conventional treatments.

As the CEO of AROMICS, I bring a strong background in molecular biology, oncology research, and business leadership. My vision for the company is to advance our groundbreaking novel therapies, drive innovation in the biotech sector, and build strategic partnerships that accelerate the development of our pipeline products, like NAX035, to improve patient outcomes. The support of a regulatory expert on drug development gives us the extra advantage we need to successfully execute our long-term plans and achieve the company's strategic goals.

What is AROMICS’ long-term vision in developing oncology therapies, and how do you plan to differentiate in such a competitive biotech market?

AROMICS' long-term vision in developing oncology therapies is to create innovative, RNAtargeted small molecules that effectively silence oncogene expression, offering a new approach to cancer treatment. To differentiate in a competitive biotech market, AROMICS focuses on targeting RNA, an area less explored compared to traditional protein targets, leveraging their unique technology platform to develop novel therapies with higher specificity, fewer side effects, and broader applicability across various cancers.

Could you provide an overview of the mechanism of action of the RNA-targeted compounds for treating solid tumours in your pipeline, and how it differs from existing therapies?

Our pipeline includes a novel family of all molecules specifically targeting complex structures on the messenger RNA (mRNA) of a critical protein essential for cancer cell survival and proliferation. By targeting the mRNA directly, instead of the proteins, the compound offers a more upstream intervention in the gene expression process, potentially reducing the development of resistance usually associated to protein overexpression. This mechanism allows for a more precise attack on cancer cells while minimizing off-target effects, potentially leading to improved efficacy and safety profiles.

What scientific and technical challenges have you faced during the development of these RNA-targeting compounds, and how have you overcome them?

During the development of the compounds included in our pipeline, AROMICS faced several scientific and technical challenges, including optimizing the molecules’ selectivity, manufacturing and efficacy and ensuring it specifically targets the RNA of the selected gene without affecting normal cellular functions.

To overcome these challenges, the company utilized advanced molecular biology and preclinical techniques to optimize affinity, specificity and efficacy. Rigorous preclinical testing and iterative optimization were employed to

refine the molecules, improving its efficacy and minimizing potential side effects.

Could you share the current status of your clinical trial and the key regulatory milestones you aim to achieve in the coming year?

Our first lead candidate NAX035 is currently advancing up to early clinical development stage, focusing on assessing its safety, pharmacokinetics, and efficacy in solid tumor models. The next steps involve completing preclinical studies and submitting an Investigational New Drug (IND) application to regulatory authorities. In the coming year, AROMICS aims to achieve key regulatory milestones, including initiating Phase I clinical trials to evaluate the safety and dosage of the compound in humans, generating preliminary efficacy data, and engaging with regulatory agencies to ensure compliance and alignment with development guidelines. Achieving these milestones will be critical to advance our first

lead compound toward later-stage clinical trials and to establish the appropriate partnerships to ultimately bring the compound to market. BNN has already delivered exceptional work by helping us build a strong regulatory strategy to advance NAX035 towards the clinic.

In a sector that highly values collaboration, can you tell us about your current strategic alliances with BNN and how these collaborations are helping to accelerate the development of your product?

AROMICS aims to achieve key regulatory milestones, including initiating Phase I clinical trials to evaluate the safety and dosage of the compound in humans.

Our collaboration leverages BNN’s strengths in regulatory expertise, and market access strategies, alongside AROMICS' innovative RNA-targeting technology. By working together, we have been able to reduce development timelines, lower costs, and improve the chances of successfully achieving IND, ultimately speeding up NAX035's journey to clinical trials.

Contact Daniel Garcia daniel.garcia@bnn.at

CONTRIBUTION FROM ACIB

Green Pharmaceuticals from Lignin: A Sustainable Revolution in the Pharma Industry

Imagine a future where the pharmaceuticals we rely on every day are derived from renewable agricultural and forestry waste rather than non-renewable petroleum resources. This vision represents a transformative shift in the pharmaceutical industry towards sustainability and circular economy. The advent of green and bio-based pharmaceuticals heralds a new era where innovative approaches in green chemistry and biotechnology can

produce therapeutic agents and with a significantly reduced ecological footprint. This holistic strategy aligns with the increasing global demand for sustainable solutions, setting the stage for a future rich in renewable medicines and adjuvants.

The traditional pharmaceutical industry is fully dependent on petrochemicals, which contribute to environmental pollution and the

Research group of University of Graz © Barta group

depletion of finite natural resources. As the world becomes more conscious of the environmental impact of industrial processes, there is a growing demand for sustainable, economically viable and climate-neutral provision of pharmaceutical compounds. This demand has sparked interest in alternative raw materials that can replace fossil-based precursors with renewable resources without compromising on performance.

Enter Lignin: A Renewable Resource

Lignin, a major component of biomass, presents a promising solution. It is a complex organic polymer found in the cell walls of plants, most prominently in wood and bark. In fact, lignin is the largest natural source of aromatic carbon on Earth, yet it has been underutilized in industrial applications. Traditionally, lignin was considered a waste byproduct in the pulp and bioethanol industries and used only as low-grade fuel. However, recent advancements in green chemistry have highlighted lignin’s potential as a rich source of functionalized aromatic compounds that can be efficiently transformed into complex molecules. This makes lignin an attractive, renewable alternative to petrochemicals for drug synthesis, for example.

From Lignin to Green Pharmaceuticals

The transition to green pharmaceuticals represents a scientific challenge and requires a multidisciplinary approach, combining expertise in catalysis, green chemistry, and pharmaceutical sciences. Ultimately, the goal is to design and optimize catalytic reactions that efficiently convert lignin-derived platform chemicals into valuable pharmaceutical compounds.

The development process addresses two fundamental aspects: atom economy and sustainability. Atom economy refers to the efficiency of a chemical reaction in terms of the incorporation of all materials used into the final product. Maximizing it reduces waste and improves the sustainability of the synthesis process.

Alternative Solvents and Reaction Conditions

Another critical aspect is the use of alternative solvents, such as deep eutectic solvents, which can enhance reaction efficiency while minimizing environmental impact. These solvents can be fully biodegradable, non-toxic, recyclable and designed to optimize specific chemical reactions, further contributing to the green chemistry metrics of the process.

Biological Screening and Optimization

Once the target compounds are synthesized, they undergo biological screening assays to evaluate their pharmacological activity. This step is essential for identifying lead compounds with promising therapeutic potential, such as those effective against infectious diseases, inflammation, and cancer. The insights gained from these screenings guide further optimization of the compounds, ensuring that they are not only environmentally friendly but also therapeutically effective.

Economic Feasibility and Scalability

While the scientific and environmental benefits of green pharmaceuticals are clear, their economic viability is equally important. The synthetic routes developed for lignin-derived

pharmaceuticals must be cost-effective and scalable to ensure they can be adopted in industrial settings. Economic assessments are conducted to evaluate the overall feasibility of these processes, paving the way for their commercialization and widespread use.

Partnering for a Greener Future

The Austrian Centre of Industrial Biotechnology (acib) and their key researchers, Katalin Barta Weissert and Markus Hochegger from University of Graz are at the forefront of this green revolution in pharmaceuticals and adjuvants, such as surfactants. They offer a unique opportunity for collaboration in the co-development of innovative catalytic methods for the synthesis of pharmaceutical compounds directly from lignin-derived chemicals. Partners will have access to cutting-edge research and development in the identification of lead compounds with significant biological activity and the optimization of green chemistry processes.

Opportunities for Collaboration

 Novel Catalytic Methods: Collaborate on the development of new catalytic processes that efficiently convert lignin into valuable pharmaceutical compounds and/ or adjuvants, such as surfactants.

 Lead Compound Identification: Work together to discover and identify novel compounds with promising activity against major health challenges such as infectious diseases, inflammation, and cancer.

 Process Optimization: Enhance the sustainability of chemical processes by developing cleaner reaction conditions and solvent systems.

 Economic Feasibility: Demonstrate the practicality of these green synthetic routes through comprehensive economic assessments, contributing to the advancement of lignin valorization and biorefinery processes.

The shift towards green pharmaceuticals and adjuvants from lignin represents a major step forward in the quest for sustainability in the pharmaceutical industry. By embracing this innovative approach, we can reduce our reliance on non-renewable resources, decrease environmental pollution, and create a new generation of eco-friendly medicines. As the world moves towards a more sustainable future, lignin-based pharmaceuticals offer a glimpse of what is possible when science and sustainability go hand in hand.

Contact

ACIB GmbH – Austrian Centre of Industrial Biotechnology Katrin Weinhandl katrin.weinhandl@acib.at www.acib.at

SSbD meets Multifunctional Biomaterials: BNN Visits NABIHEAL

Partner University of Maribor

N

ABIHEAL is a Horizon Europe project aiming to advance wound care options. Collectively the consortium will develop multifunctional biomaterials to improve wound management, relying on antimicrobial nanostructured materials. Alongside the development of these materials, BNN is leading Safe-and-Sustainable-by-Design activities. In order to assess the current situation and subsequently provide recommendations for further improvements in the realm of safety and sustainability, BNN set up questionnaires and

bilateral meetings to gather information from all technical partners. Additionally, where possible laboratory visits will be conducted to see the facilities first hand.

Earlier this year, BNN representatives Johanna K Scheper and Julia Voglhuber-Höller took the quick journey from Graz to Maribor, Slovenia, to visit the facilities of NABIHEAL partner Selestina Gorgieva. Selestina is a senior research fellow at the Institute of Engineering Materials and Design at the Faculty of Mecha -

nical Engineering of the University of Maribor. BNN visited part of the Institute where Selestina and her team are developing biobased options for wound dressings in a small scale in collaboration with groups from the Faculty of Natural Sciences and Mathematics and the Faculty of Electrical Engineering and Computer Sciences, both of the University of Maribor. BNN got a peek into day-to-day business in their laboratories and learned more about how the material is produced and characterized, while gathering additional information for advancing NABIHEAL´s SSbD concept.

NABIHEAL project has received funding from the European Union’s HORIZON EUROPE research and innovation programme under grant agreement n°101092269

Role of BNN in NABIHEAL project

SSbD concept & guidelines, Dissemination, Communication & Stakeholder Involvement

Contact Julia Voglhuber-Höller julia.voglhuber-hoeller@bnn.at www.nabiheal.eu

CONTRIBUTION FROM GRAZ UNIVERSITY OF TECHNOLOGY

Enzymes Instead of Cyanide: Researchers Develop Biocatalytic Process for Nitrile Production

Aresearch team from TU Graz and the Czech Academy of Sciences has used two enzymes to eliminate the need for highly toxic cyanide in the production of nitriles.

If the household cleaner emits a lemon-like odor, this may be due to a nitrile called citronellyl nitrile. These versatile chemical nitrile groups are also used in the manufacture of active pharmaceutical ingredients, superglue and chemical-resistant gloves. The prevalent production process used so far has required a chemical reaction of certain molecules with highly toxic cyanide. Margit Winkler from the Institute of Molecular Biotechnology at TU Graz, together with Ludmila Martínková from the Institute of Microbiology at the Czech Academy of Sciences, has now developed a biocatalytic process that does not require cyanide, works at room temperature and therefore requires less energy and produces less harmful waste. The project was funded by the Austrian Science Fund FWF and the Czech Science Foundation (GACR).

Two enzyme-guided steps

To replace the cyanide, the research group uses enzymes and combines three individual reactions into a cascade. The starting materials are carboxylic acids, such as fatty acids from plant oils or lignin, which is a by-product of wood processing. In the first step, the carboxylic acid is converted to an aldehyde by adding sugar, oxygen and the enzyme carboxylate reductase contained in living bacterial cells. However, this aldehyde is highly reactive and therefore unstable, and in many cases also volatile. To capture this substance, the aldehyde is allowed to react with hydroxylamine, which converts it into oxime, which is stable.

Oxime is a ‘watered’ form of nitrile, which is why the enzyme aldoxime dehydratase is used in the final step. This enzyme is also confined in bacterial cells and is responsible for water abstraction from the oxime. Once this has been done, the cascade has achieved its objective and the desired nitrile has been produced.

This method can now be used for the preparation of small nitrile quantities. This is already a promising technology for very potent fragrances, for example, of which only a small amount is needed to achieve an effect. Optimization work is still required for the production of larger quantities of nitrile in order to be able to use the biocatalytic process at reasonable costs. Currently, highly diluted solutions are used in the first process step and a large reactor would be required to produce large quantities, which is not economic yet. Margit Winkler is therefore already conducting research on how to make the first step more efficient. Dehydration of the oxime alone, on the other hand, is extremely efficient and already reached technical maturity for production today.

A bio-based process

“I’ve been interested in cyanide chemistry ever since I wrote my master thesis, and as we know from Agatha Christie’s novels, cyanide is highly toxic,” says Margit Winkler. “It was therefore important for us to find a way to avoid this hazardous substance in production. The fatty acids we use come from vegetable oils. So, we really do have a bio-based production method here. We would now like to improve it even further so that it can be used widely.”

Contact

Graz University of Technology

Birgit Baustädter birgit.baustaedter@tugraz.at www.tugraz.at

A cyanide-free chemoenzymatic cascade for nitrile synthesis. Image source: IMBT - TU Graz

Driving Sustainability and Efficiency in Drug Discovery: Leveraging Enalos Asclepios KNIME Nodes for In Silico Advancements

Member NovaMechanics is an R&D-performing SME committed to the computeraided design of new materials, small molecules and nanoparticles. NovaMechanics is focused on the development and implementation of in silico methods to guide decisions in the design and selection of promising candidates. Here they provide a glimpse into some of their recent advances.

Advancing Sustainability in Drug Discovery

Structure-based drug design is at the core of pharmaceutical research for drug development or repurposing of existing drugs. In this context computational techniques, such as molecular docking and molecular dynamics simulations, are essential for enhancing sustainability in the pharmaceutical sector. These methodologies are cost-effective and enable researchers to accurately predict and model drug-target interactions, which reduces the reliance on extensive laboratory testing. Moreover, computational approaches minimize the use of chemicals and biological materials, thereby reducing waste and lowering the environmental impact.

Streamlining Small Molecule Design with Enalos Asclepios KNIME Nodes

NovaMechanics has developed the Enalos

Asclepios KNIME nodes [1-4], a toolkit designed to automate standard computational chemistry procedures. These tools are particularly useful in small molecule drug design, offering an efficient solution for tasks like molecular docking, high-throughput virtual screening and molecular dynamics. By automating these processes, the Enalos Asclepios KNIME nodes streamline the drug discovery process, reducing manual effort and optimizing resource usage. The toolkit integrates easily into existing workflows via the KNIME analytics platform, thus providing a practical choice for researchers by improving efficiency and sustainability. NovaMechanics focuses on practical, user-friendly tools that demonstrate the company’s commitment to advancing research in a responsible and efficient manner.

Asclepios automation in Computational Chemistry - Enhancing Efficiency

NovaMechanics is committed to advancing the field by developing reliable and efficient in silico tools for addressing complex chemical challenges. The Enalos Asclepios KNIME nodes have been instrumental in several key projects, including SCENARIOS, NEMESIS and RNSMOKE. These tools have been used to screen and rank the effects of industrial chemicals like Per- and polyfluoroalkyl substan -

ces (PFAS) on protein biomolecules (SCENARIOS and NEMESIS), and to evaluate natural products as potential alternatives for smoking cessation (RNSMOKE). Through these efforts, we aim to provide innovative solutions that support better understanding and management of chemical impacts on health.

PFAS are a group of synthetic chemicals that have been widely used in various industries since the late 1930s, primarily for their water- and oil-repellent properties. Understanding how PFAS bind to proteins, particularly nuclear receptors, is crucial for characterizing their potential toxicity and overall chemical mode of action. This knowledge is essential for addressing PFAS pollution control, which is the primary goal of SCENARIOS. Within the project, a comprehensive study is being designed to elucidate the interaction mechanisms between PFAS and the Peroxisome Proliferator-Activated Receptors (PPAR α and PPAR γ ), which are part of the NR1C subfamily of ligand-activated transcription factors. The objective is to use molecular simulations to determine whether various PFAS act as agonists

for these receptors. Understanding the ability of PFAS to interact with biomolecules like PPAR α and PPAR γ is critical, as these interactions facilitate the transport of PFAS within the body, potentially influencing their toxicological profile.

Asclepios in silico investigations of endocrine-disrupting chemicals (EDCs)

PFAS are classified as endocrine-disrupting chemicals (EDCs) that disrupt lipid and glucose metabolism in organs such as the liver and pancreas, while also interfering with hormonal processes. Exposure to EDCs is linked to higher risks of obesity, atherosclerosis, and type 2 diabetes, with effects that can span generations.

However, the full metabolic impact remains unclear, limiting effective risk assessment due to a lack of mechanistic data and predictive models. The NEMESIS consortium is working to fill these knowledge gaps by combining multiple disciplines to study the metabolic effects of EDCs using in silico, in vitro, in vivo, epidemiological, and systems biology met-

Figure 1: An example workflow for molecular docking and molecular dynamics simulations by mean of the Enalos Asclepios KNIME nodes.

Figure 2: The structure of the homo sapiens Peroxisome Proliferator-Activated Receptor alpha (PPAR α , PDB ID: 3VI8) nuclear receptor. The APHM13 agonist is also illustrated.

Figure 3: CYP2A6 in complex with nicotine (black) adapted from the crystal structure with PDB ID: 4EJJ6 and representative conformations of natural products (green) docked to CYP2A6, via the Enalos Asclepios tools. The heme moiety of the cytochrome is coloured grey.

hods. The goal is to create data-driven models to understand EDCs' mechanistic effects, focusing on dose-response relationships. This involves developing computational tools like adverse outcome pathways (AOPs), machine learning, and in silico models for diverse datasets. NovaMechanics' Asclepios tools are crucial, using in silico and cheminformatics methods to identify endocrine-disrupting events and build comprehensive models, especially with omics data.

Asclepios tools in fighting smoking

Smoking poses significant public health risks, contributing to various diseases such as cardiovascular issues, cancer, pulmonary disorders, and neurodevelopmental problems in infants exposed to nicotine during pregnancy. In Europe, nearly 20% of the population are daily smokers, leading to substantial socioeconomic costs. Nicotine Replacement Therapy (NRT), the primary smoking cessation strategy, has limited success due to varying nicotine metabolism rates in individuals, largely influenced by the enzyme cytochrome P450 2A6 (CYP2A6). Given the enzyme’s role in nicotine addiction, designing inhibitors of CYP2A6 has emerged as a potential treatment strategy.

NovaMechanics is exploring, within RNSMOKE, the use of natural products as CYP2A6 inhibitors, leveraging their abundance, cost-efficiency, and ease of isolation. This approach aims to enhance smoking cessation efforts by integrating natural CYP2A6 inhibitors into existing NRT protocols, potentially through diet changes or dietary supplements. Utilizing the Enalos Asclepios workflow, NovaMechanics has identified approximately 5,300 natural compounds (through virtual screening) as potential CYP2A6 inhibitors, offering a promising direction for developing more effective nicotine addiction treatments.

1. D. Papadopoulou, et al., Int. J. Mol. Sci. 22, 10220 (2021).

2. E.A. Stylianaki, et al., Bioorg. Med. Chem. Lett. 103, 129690 (2024).

3. M. Antoniou, et al., Int. J. Mol. Sci. 25, 5216 (2024).

4. K.D. Papavasileiou, et al., in Computational Toxicology: Methods and Protocols, O. Nicolotti, Ed., Springer US (2024).

Contact

NovaMechanics Ltd Antreas Afantitis info@novamechanics.com www.novamechanics.com

CONTRIBUTION FROM RCPE

PharmECO Project

Proposal Approved

RCPE – Research Center Pharmaceutical Engineering GmbH – is happy to announce that the proposal for the €41M PharmECO project has been approved. Co-funded by industry and the European Union under the Innovative Health Initiative, PharmECO aims to revolutionize pharmaceutical manufacturing with cutting-edge sustainable and scalable technologies and harmonized sustainability assessment methodologies.

Kicking off on 1 October 2024, the project brings RCPE together with 30 other esteemed European partners to drive innovation and sustainability in the industry.

The role of University of Graz and RCPE will be to develop process-intensified and scalable methodologies for the synthesis of active pharmaceutical ingredients (APIs) that yield fewer impurities, side products, and waste, with continuous processing serving as the overarching theme. Specifically, they will focus on solventminimized protocols via mechanochemistry/ reactive extrusion, the application of water

as a sustainable reaction medium, photo- and electrochemical processes, biocatalytic cascades, and the use of renewable raw materials to mitigate environmental and economic burdens. In addition, they will employ model-based advanced control using process analytical technology (PAT) concepts, soft sensor concepts, human-in-the-loop concepts as well as digital twins in biomanufacturing, advancing sustainability via optimizing product quality and reducing waste. Close collaboration with major pharmaceutical companies will ensure the transfer of these processes into industrial manufacturing practices.

Contact Research Center Pharmaceutical Engineering (RCPE)

Claudia Pock claudia.pock@rcpe.at www.rcpe.at

CONTRIBUTION FROM RCPE

COMET Module Twin4Pharma - Digital and Green (Twin) Transition of Pharmaceutical Product and Process Development

The pharmaceutical industry is currently facing significant challenges, including the need to enhance the sustainability of its product and process development. Traditional pharmaceutical development is costly, timeconsuming, and resource-intensive, often involving extensive trial-and-error methods and outdated processes. Moreover, only a fraction of drug candidates reaches the market, and those that do exceed costs of €2-3 billion over a development period of approximately 12 years. These inefficiencies, coupled with environmental concerns, have underscored the urgent need for a transformative approach. The FFG COMET Module Twin4Pharma project, spanning from July 2024 to June 2028, aims to address these challenges by driving a green and digital transition in pharmaceutical product and process development.

Twin4Pharma

The COMET Module Twin4Pharma is a €3.75 million initiative led by the Research Center for Pharmaceutical Engineering (RCPE) under the guidance of Scientific Director Dr. Sarah Stryeck and Deputy Scientific Director Prof.

Twin4Pharma Project Structure - © RCPE GmbH

Dr. Oliver Kappe. The project brings together a consortium of 18 partners, including five scientific and 13 industrial institutions. The primary objective is to enable a sustainable and efficient digital transformation of pharmaceutical development by integrating cut-

ting-edge digital technologies such as artificial intelligence (AI) and mechanistic modeling into pharmaceutical processes. Through this entanglement of the digital technologies, advantages from both worlds will be invigorated and thereby bring pharmaceutical engineering to the next level through technologies.

Current Challenges in Pharmaceutical Development

Pharmaceutical companies face pressure to accelerate drug development while maintaining sustainability due to several factors, e.g.:

 Trial-and-error methodologies: The reliance on laborious and repetitive laboratory testing extends development times and increases costs.

 Inefficient scale-up methods: Outdated processes and environmentally harmful batch production techniques further contribute to inefficiencies.

 Low success rates: Only 1 out of every 10,000 drug candidates successfully reaches the market after an average of 12 years, leading to massive financial losses.

 Environmental and supply chain impacts: Current non-green production technologies force companies to outsource to regions like China and India, leading to supply chain disruptions and environmental harm.

Addressing these issues requires an innovative approach that combines sustainability with advanced digital tools to reduce material usage, energy consumption, and waste generation, thereby improving overall efficiency.

The Twin Transition: Digital and Green Transformation

The COMET Module Twin4Pharma seeks to create a holistic digital platform to drive forward the twin transition:

 Digital Transition: This involves the adoption of advanced digital tools such as AI, predictive modeling, and mechanistic simulations to improve process precision and reduce failures.

 Green Transition: This focuses on reducing the environmental impact of pharmaceutical production through cleaner, more sustainable processes.

By merging these two transformations, the project aims to make pharmaceutical production not only faster and more cost-effective but also more sustainable and environmentally friendly.

Main Research Areas

 Digitalization and Sustainability

The integration of digitalization with sustainability is at the heart of the Twin4Pharma project. Advanced digital tools, including machine learning and hybrid modeling, are being deployed to enhance the efficiency of product and process development. Predictive algorithms allow for the accurate forecasting of process outcomes, minimizing waste and energy consumption. By aligning these efforts with the Sustainable Development Goals (SDGs), the project promotes a more environmentally responsible approach to pharmaceutical production. The adoption of digital tools also facilitates real-time monitoring and optimization of production processes, enabling pharmaceutical companies to reduce their carbon footprint, save resources, and ensure compliance with environmental regulations.

 Computationally-driven Pharmaceutical Processes for Small Molecules

Small molecule drugs form the backbone of many pharmaceutical treatments, and the Twin4Pharma project is leveraging computationally-driven processes to revolutionize their development. Techniques such as flow chemistry, purification, and crystallization are being enhanced through advanced simulations and predictive algorithms.

These technologies allow for the precise optimization of reaction conditions, reducing the need for extensive empirical testing. By reducing the reliance on trial-and-error methods, computationally-driven processes accelerate the drug development timeline and improve scalability. This approach also ensures greater consistency in drug manufacturing, ultimately benefiting both pharmaceutical companies and patients by delivering higher-quality products in shorter timeframes.

Conclusion

The Twin4Pharma project has the potential to reshape the future of pharmaceutical production.

 Computationally-driven Processes for Biologics

Biologic drugs present unique challenges due to their complexity and sensitivity. The Twin4Pharma project is using computational tools to optimize processes such as mixing and freeze-thaw cycles, which are crucial for the stability and efficacy of biologics. Advanced modeling and simulation techniques are enabling pharmaceutical companies to precisely control and optimize these processes, reducing the risk of protein denaturation and aggregation. By leveraging these tools, the industry can ensure higher quality and consistency in biologics production, leading to improved patient outcomes and a more reliable supply of biologic therapies.

The COMET Module Twin4Pharma represents a significant step towards sustainability in the pharmaceutical sector. By embracing digitalization and green technologies, the project aims to transform pharmaceutical development into a faster, more cost-effective, and environmentally responsible process. The integration of AI, predictive modeling, and computational tools will not only enhance process efficiency but also reduce waste and energy consumption, aligning the pharmaceutical industry with global sustainability goals. With its focus on digital and green transitions, the Twin4Pharma project has the potential to reshape the future of pharmaceutical production, ensuring that medicines reach patients faster and at lower costs while minimizing environmental impact.

Contact Research Center Pharmaceutical Engineering (RCPE) Sarah Stryeck sarah.stryeck@rcpe.at www.rcpe.at

Member Updates

MEMBER INTERVIEW

OCSiAl Europe S.a.r.l.

OCSiAl is the world’s largest manufacturer of graphene nanotubes, owning the only scalable technology capable of synthesizing them in industrial volumes.

A graphene nanotube, also known as a single wall carbon nanotube, is a rolled-up sheet of graphene. OCSiAl produces high-purity graphene nanotubes under the brand name TUBALL™. The advantages of TUBALL™ nanotubes in comparison with standard additives are related to their unique combination of properties, including high electrical and thermal conductivity, strength, and flexibility, which allow them to significantly improve up to 50% of all materials on the global market.

To simplify nanotube handling, OCSiAl has developed TUBALL™-based solutions for various applications, including electrochemical power sources, elastomers, composites, plastics, paints, and coatings. For example, TUBALLTM

BATT, an ultrafine dispersion of graphene nanotubes in liquid carriers, is a ready-to-use solution designed for high-energy anodes and cathodes, enhancing the energy density and durability of batteries. The TUBALL™ MATRIX nanotube concentrate product line was specifically designed to provide superior electrical conductivity and enhance the mechanical properties of various elastomers, thermosets, and thermoplastics.

Headquartered in Luxembourg, OCSiAl is represented throughout Europe, the US, South Korea, China, Hong Kong, Canada, Mexico, Malaysia, Taiwan, Japan, and India. OCSiAl collaborates with more than 1,500 companies in over 50 countries worldwide.

We got to know Gunther Van Kerckhove, Lead Manager, Product Safety & Regulatory affairs for OCSiAl.

Why did you decide to become a BioNanoNet member and what do you expect from the membership?

The work of the BNN team and Andreas Falk persuaded me! I believe BNN has a perfect network for us. So, I expect that the support BNN offers can be very beneficial to us as a graphene nanotube producer.

Sustainability is a core value of BNN. What strategies have you implemented to improve your organization’s sustainability?

We leverage energy and environmental regulatory initiatives, improve the ROI of our decarbonization solution from the productions we have and are planning, and create legally compliant technical solutions at all our facilities.

What led you to your profession?

I care about safety and the environment since the beginning (which is already 24 years).

What does your typical workday look like?

Daily product safety and regulatory affairs questions from our customers and giving support to case studies that improve our product safety.

What’s the best aspect of your job?

Being part of platforms and events where we can be a support by giving advice, sharing knowledge and showing/explaining what is relevant for the industry.

What would you advise a young person considering working in your field?

Safety first!

Who are people in your field that inspire you?

Everyone from the nano-industry from scientist, regulators, and governance... We all can learn from everyone every day.

5-second answers

What was your dream job when you were a kid?

To become a biologist.

If you could study anything (new) right now, what would it be?

Learning Swiss German ;) Office, home office or hybrid?

Home office (since June 2016 already)

Which book have you most enjoyed reading lately?

Swiss-German survival guide :) or I’m still trying.

If you could make any activity an Olympic discipline, in which would you win a medal?

Javelin

What is your motto?

Product safety never takes a break!

Contact

OCSiAl Europe S.a.r.l. Gunther Van Kerckhove gunther.van.kerckhove@ocsial.com www.ocsial.com tuball.com

TU Graz Revolutionizes Simulation of Metal-Organic Frameworks (MOFs)

Due to the complex structures of microporous crystals known as MOFs, reliable simulations of their properties have been difficult until now. Machine learning provides the solution.

Hydrogen storage, heat conduction, gas storage, CO2 and water sequestration – metalorganic frameworks (MOFs) have extraordinary properties due to their unique structure in the form of microporous crystals, which have a very large surface area despite their small size. This makes them extremely interesting for research and practical applications. Howe -

ver, MOFs are very complex systems that have so far required a great deal of time and computing power to simulate accurately. A team led by Egbert Zojer from the Institute of Solid State Physics at Graz University of Technology has now significantly improved these simulations using machine learning, which greatly accelerates the development and application of novel MOFs. The researchers have published their method in the Nature Research journal npj Computational Materials .

Read the whole article here .

The simulation of the heat conduction properties of MOFs is carried out with very high accuracy using the new method. Image source: IF - TU Graz

Schematic representation of a metal phthalocyanine molecule that is set into two vibrations, creating a rotating electric dipole moment in the plane of the molecule and thus a magnetic field. Image source: Wilhelmer/Diez/Krondorfer/Hauser - TU Graz

GRAZ UNIVERSITY OF TECHNOLOGY

Switching Nanomagnets Using Infrared Lasers

Physicists at TU Graz have calculated how suitable molecules can be stimulated by infrared light pulses to form tiny magnetic fields. If this is also successful in experiments, the principle could be used in quantum computer circuits.

When molecules are irradiated with infrared light, they begin to vibrate due to the energy supply. For Andreas Hauser from the Institute of Experimental Physics at Graz University of Technology (TU Graz), this well-known phenomenon was the starting point for considering whether these oscillations could also be used to generate magnetic fields. This is because atomic nuclei are positively charged, and when a charged particle moves, a magnetic field is

created. Using the example of metal phthalocyanines – ring-shaped, planar dye molecules – Andreas Hauser and his team have now calculated that, due to their high symmetry, these molecules actually generate tiny magnetic fields in the nanometer range when infrared pulses act on them. According to the calculations, it should be possible to measure the rather low but very precisely localized field strength using nuclear magnetic resonance spectroscopy. The researchers have published their results in the Journal of the American Chemical Society .

Read the whole article here

Infineon CEO Jochen Hanebeck holds one of the world’s first 300 mm GaN Power wafers produced in an existing and scalable highvolume manufacturing environment.

Infineon Pioneers World’s First 300 mm Power Gallium Nitride (GaN) Technology – an Industry Game-Changer

 Infineon will shape the rapidly growing GaN market with this groundbreaking GaN 300 mm technology

 Infineon leverages existing large scale 300 mm silicon manufacturing to maximize capital efficiency in GaN production

 300 mm GaN will help achieve cost parity with silicon over time

Infineon Technologies AG (FSE: IFX / OTCQX: IFNNY) announced that the company has succeeded in developing the world’s first 300 mm power gallium nitride (GaN) wafer technology. Infineon is the first company in the world to master this groundbreaking technology in an existing and scalable high-volume manufacturing environment. The breakthrough will help substantially drive the market for GaN-based power semiconductors. Chip production on

300 mm wafers is technologically more advanced and significantly more efficient compared to 200 mm wafers, since the bigger wafer diameter offers 2.3 times more chips per wafer.

GaN-based power semiconductors find fast adoption in industrial, automotive, and consumer, computing & communication applications, including power supplies for AI systems, solar inverters, chargers and adapters, and motor-control systems. State-of-the art GaN manufacturing processes lead to improved device performance resulting in benefits in end customers’ applications as it enables efficiency, performance, smaller size, lighter weight, and lower overall cost. Furthermore, 300 mm manufacturing ensures superior customer supply stability through scalability.

Read the whole article here .

JOANNEUM RESEARCH

Cicada Wings as a Template for Antibacterial Surfaces

How nanostructured materials can eliminate pathogenic microorganisms on everyday surfaces, such as mobile phones and food packaging, was researched as part of a master's thesis at JOANNEUM RESEARCH MATERIALS. A fascinating antibacterial nanostructure from nature serves as a model: the surface of the cicada wing.

How do cicadas protect themselves from bacteria and what does this have to do with packaging material?

Cicada wings are equipped with cone-shaped nanostructures that act like tiny needles and have a bactericidal effect by stretching or even piercing the membrane of bacteria. These nanostructures are hydrophobic, which means that they can repel water and thus create a self-cleaning surface. At JOANNEUM RESEARCH, master's student Tina Spirk investigated these natural structures and recreated them artificially. Research group leader Barbara Stadlober explains the background: “We have transferred the nanostructure of the cicada wing surface onto a film over a large area using roll-to-roll (R2R) UV nanoprinting. This enables the efficient pro -

Stamp for large-area printable antibacterial films

JOANNEUM RESEARCH

duction of an artificial cicada wing film which, when applied to the surfaces of everyday objects, furniture or public transport, makes them antibacterial without chemicals and is also water-repellent and anti-reflective.”

The researchers demonstrated the hydrophobicity by measuring a high contact angle of water and oil droplets on the artificial cicada wing film. Light reflection is reduced by 1-2 per cent due to the nanostructured film surface, which was demonstrated by means of optical transmission measurements. In addition, tests such as bacterial colony counts, fluorescence and scanning electron microscopy were carried out to observe the behavior of bacteria on the nanostructured films. It was shown that the cicada wing structures lead to a significant death of gram-negative bacteria, such as E. coli. These overstretch their cell membrane in an attempt to cling to the flexible nanocones, which leads to their death.

Read the whole article here .

JOANNEUM RESEARCH

Green Steel: How Steel Production can Reduce its Emissions

The steel industry accounts for more than 7% of global CO2 emissions. In order to make the industry greener, several adjustments are currently being made. JOANNEUM RESEARCH is contributing its expertise.

Last year, the 71 World Steel Association (worldsteel.org) member states alone produced a total of 145.5m tons of steel. Production is energy-intensive and generates huge quantities of CO2. But is there anything we can do to counteract these problems?

Steel from scrap steel

“Using scrap steel instead of the primary raw material iron ore for steel production delivers a reduction in carbon emissions of up to 75%,” says Harald Ganster. “And it makes production more energy efficient,” adds his DIGITAL Institute colleague Malte Jaschik. The pair are currently working on an innovative approach to

the material characterization of scrap metal as part of the InSpecScrap project, using artificial intelligence (AI) and hyperspectral multisensorics to characterize the composition of the metal – which has a decisive influence on the quality of the steel produced. This technique allows for detection of impurities and the automated assessment of quality specifications. “The findings will lay the foundations for the development of new approaches to AIbased classification methods for the future, which adds another key aspect to the steel industry digitalization chain,” the researchers point out. The institute is working closely with TU Graz, the K1-MET competence centers and the Know Center. Industrial partners Marienhütte (a steel mill) and Voestalpine Stahl Donawitz are also supporting the project.

Read the whole article here.

© Centre for Trophoblast Research, Cambridge, UK - https:// www.trophoblast.cam. ac.uk/Resources/enders

MEDICAL UNIVERSITY OF GRAZ

IMPLANTEU –A Marie Skłodowska-Curie Actions Doctoral Network (MSCA-DN)

Innovative approaches to embryo implantation research in health and disease

IMPLANTEU is dedicated to pioneering research in the field of embryo implantation in health and disease. This international network is committed to developing a molecular blueprint of implantation, especially in humans and cattle. This will advance knowledge and research tools in the field of human implantation and will enhance implantation fitness for agricultural productivity. The project leverages cross-disciplinary expertise spanning reproductive and stem cell biology, medicine, physiology, ethics, law, and advanced technologies such as stem cell-based embryo models, organoids, machine learning, and organson-chip. This program is designed to cultivate the next generation of researchers, equipping them with the necessary skills to

contribute significantly to the field of reproductive success and embryo implantation research. We are excited to announce 13 doctoral early-stage researcher (ESR) positions, available from October 2024 , geared towards candidates passionate about the implications of embryo implantation in human health and agriculture. Selected candidates will engage in multidisciplinary research, participate in international secondments across academic and industrial settings, and contribute to high-impact publications and conferences.

Read the whole article here .

New Horizons in Nanoscience and Advanced Materials: A Spotlight on CSBJ’s Latest Section

The Computational and Structural Biotechnology Journal (CSBJ), an online gold open access journal with 2023 CiteScore of 9.3 and an Impact Factor of 4.4, continues to drive scientific innovation with the launch of its new section, " Nanoscience & Advanced Materials ". Under the expert leadership of Antreas Afantitis, the Editor-in-chief of this section, CSBJ is poised to make significant contributions to the fields of nanoscience, materials science, chemistry, physics, and biomedical engineering.

This new section is dedicated to advancing scientific knowledge and fostering technological innovation at the crossroads of these dynamic disciplines. Researchers and scientists are encouraged to submit their work, covering a broad range of topics that delve into the nanoscale world and its transformative applications. The section aims to be a hub for groundbreaking research that enhances our understanding of nanoscience and its potential to revolutionize various industries.

Read the whole article here .

High-resolution thermal camera with ATEX-certified explosion protection ©OCSiAl

OCSIAL

In Safe Hands: Graphene Nanotubes Power Reliable Thermal Cameras for Firefighters

MEDIRLAB, a Hungarian manufacturer, has expanded its production line with an explosion-proof thermal camera to meet the demands of firefighters in the most challenging environments. The enhanced ATEX safety is achieved by integrating TUBALLTM graphene nanotubes in the silicone camera body parts and the aramid neck strap.

 A novel high-resolution thermal camera with ATEX-certified explosion protection helps firefighters.

 Graphene nanotubes integrated in silicone camera body parts and neck strap give the camera stable anti-static properties regardless of humidity and temperature.

 The Pyrolater camera is already in use

with fire departments in Europe and will soon be launched on the Southeast Asia (SEA) market.

The thermal imaging camera (TIC) transforms infrared radiation into visible light, enabling firefighters to see through smoke, darkness, or heat-permeable barriers, helping to locate hot spots and save lives. Equipped with a high-resolution thermal detector and a wide field of view lens, the Pyrolater camera with anti-static neck strap and body parts enhances firefighters’ efficiency and safety. Its light weight, compact size, high robustness, and ability to provide vivid, high-contrast images reveal every crucial detail, even in the most challenging scenarios.

Read the whole article here .

Wood K Plus’ R&D Activities Honored

The success of Wood K plus as non-university R&D Center in Austria is based on a very dedicated, curious and diverse scientific team. Thus, many innovations are being developed, in particular in the area of applied science, together with our company partners. To present these highly valuable results both to public and the science community we regularly participate in award competitions. In 2024 we had quite a successful year!

Living Standards Awards at 4GameChangers Festival, Category ‘Future Wood Industry’

The Living Standards Award was presented for the 10th time as part of the 4Gamechangers

Festival on 14 May 2024. The prize is awarded for innovative solutions, exportable ideas and future technologies for which standards have contributed to their success. Standards facilitate access to new international markets, drive innovation and can help to overcome current social and economic challenges. Wood K plus impressed the jury in the ‘Future Wood Industry’ category this year with the SusBind project, which involved the development of new bio-based adhesives. The standards for the production of wood-based materials such as chipboard, for the evaluation and testing of adhesives, were of decisive importance for this project.

Nomination Staatspreis (© BMK, Reich)

NOMINATION - Innovation and Research Prize of the Province of Carinthia 2024

The ‘Innovation and Research Prize’ is the highest honor awarded annually by the Carinthian Economic Promotion Fund (KWF) on behalf of the State of Carinthia in the field of innovation and research. The project ‘Green innovation: cellulose-based sensor technology for process monitoring and structural health monitoring’ from Wood K plus was nominated for the innovation prize.

We were successful with the COMET Module project ‘i3Sense’ and were able to score points with the innovation work, which is carried out in the project.

NOMINATION – Project

“Hanfkistl”

at the Innovation@school

The Economic Society of Carinthia and the Group of Engineering offices at the Chamber of Commerce in Carinthia, in cooperation with the Private foundation Kärntner Sparkasse and the Carinthian Directorate of Education, were once again looking for inspiring project ideas for the 2023/2024 school year!

The innovation@school initiative aims to give today's young generation the chance to fully utilise their creativity, activate their inventive spirit and strengthen their teamwork skills.

The 10 nominated projects were presented to a wide audience at the “innoGala” 2024 on 10 June.

NOMINATION – State Prize Technology 2024

The State Prize for Technology is the highest honor awarded by the Federal Minister for Climate Action, Environment, Energy, Mobility, Innovation and Technology (BMK) for pio -

neering solutions from Austria. Wood K plus was nominated for this award in the category ‘Innovation culture in technology companies’ and was therefore among the top three companies in this category. It was with great pleasure that the certificate was received at the awards ceremony on 11 June 2024 in the presence of Federal Minister Leonore Gewessler at the Orangery in Schönbrunn.

In addition to that, Wood K plus is also partner in the project ‘champI4.0ns’ with the opportunity to award others for their great ideas in the field of data handling and usage. As part of the champI4.0ns project, the champI4.0ns Award 2024 is looking for pioneers of Industry 4.0! Become a champI4.0n and show how your company uses data creatively, effectively and sustainably. The champI4.0ns Award 2024 honors companies that are advancing the manufacturing industry through innovative approaches. Nominate your company and take part in the champI4.0ns Award 2024!

Read the whole article with all links here

with certificate fort the nomination, awarded by

KWF © Wood K plus

MedTech.Circle

2024

9 October 2024 | Linz, Austria

The MTC's MedTech.Circle will examine how various innovations in medical technology can contribute to improving the quality of patient care and positively influence patients' experiences with the healthcare system. The MTC is even reaching for the stars with keynote speaker Gregor Puchhammer. The award-win -

ning inventor and holder of numerous patents is considered the father of the myoelectric hand prosthesis "Michelangelo Hand". At the MedTech.Circle, he will show us how innovations in medical technology are conquering space. Don't miss this and other presentations and register now!

More information

Project Presentations & Updates

NanoPAT - A Four-Year

Project Adventure Reaches

its Conclusion

It has been a really exciting four years for the NanoPAT partners, full of high-impact collaborative work by the entire consortium, delivering successfully demonstrated inline/online real-time process analytical technologies for nanoparticle production up to TRL 6/7.

The main objective of the EU H2020 project NanoPAT was to develop three novel real-time nano-characterisation process analytical technologies (PAT) to overcome the problems and limitations of conventional characterisation technologies for the characterisation of nanoparticles in industrial production processes: (1) Photon Density Wave Spectroscopy

(PDW) (developed by University of Potsdam), (2) OptoFluidic Force Induction (OF2i) (developed by BRAVE Analytics GmbH) and (3) Turbidity Spectrometry (TUS) (developed by IRIS Technology Solutions). These monitoring techniques aim to provide real-time data that can be used for digital process monitoring and product quality control.

The three technologies were successfully validated in the laboratory by our research organizations (Universidad del País Vasco/Euskal Herriko Unibertsitatea, University of Potsdam, Medical University of Graz and Zürcher Hochschule für Angewandte Wissenschaften).

Developed PAT technologies were successfully installed in at least one of the pilot plants of our five industrial partners (Covestro, Evonik, Fluidinova, Arkema and Cnano), where each has been tested and demonstrated in real industrial environments with different materials (polymers, silica, hydroxyapatite, zeolites and ceramics), complemented by safety and sustainability assessments and considering regulatory aspects (BNN, TEMASOL).

The Computational Fluid Dynamics (CFD) analysis of the process optimization of the five case studies was also successfully completed (Análisis DSC).

The PAT monitoring system developed by the project, the PAT platform, has been fully implemented, consisting of a Decision Support System and able to communicate with all the PAT systems and other relevant devices in the industrial environment. In addition, the machine learning models embedded in the monitoring software have been successfully tested on a pilot line too. Further steps towards PATs technologies standardization and data standardization have been taken, by including CHADA metadata information in the raw data exported by the PAT platform software.

All communication, dissemination and training materials created by the project are available on the project website in the ”Training Materials & Publications” section .

A full overview of the project's achievements and statements from our partners can be found in the NanoPAT Final Dissemination Video in the project’s YouTube Channel .

Training, Graphic Design, Communication & Dissemination, SSbD assessment

Contact Beatriz Alfaro-Serrano beatriz.alfaro@bnn.at www.nanopat.eu

Several BioNanoNet members were consortium partners in NanoPAT: BRAVE Analytics GmbH, Medical University of Graz, Zurich University of Applied Sciences, TEMAS Solutions GmbH, Análisis DSC and BNN itself.

project has received funding from the European Union’s HORIZON 2020 research and innovation programme under grant agreement n° 862583.

This

Role of BNN in NanoPAT

Outlook

BNN EVENTS & EVENTS SUPPORTED BY BNN

Call for Exhibitors: European Researchers’ Night 2024

27 September 2024 | Graz, Austria

Be part of an exciting event on September 27th from 3:00 PM to 8:00 PM at the University of Graz. Join us for “Life is Science in a World turned Upside Down,” where you can

showcase your research and engage with an enthusiastic audience. Don’t miss the evening’s highlight: the Science Slam Austria finale! Stop by BNN’s booth “Wie ‘nano’ ist unsere Welt?”, take a fun quiz and learn about the world of nanotechnology!

More information

Webinar: Introducing the DIAGONAL

SSbD Decision Support Tool

10 October 2024 | 13:30 -15:00 | Online

Are you developing a material that uses HighAspect Ratio Nanoparticles (HARNS) or MultiComponent Nanomaterials (MCNMs), and want to ensure it is safe and sustainable? There are plenty of tools for assessing safety and sustainability out there - DIAGONAL has been developing a Safe-and-Sustainable-byDesign (SSbD) Decision Support Tool to help you choose what is right for you!

Register here

European Summit of Industrial Biotechnology (esib)

12 - 14 November 2024 | Graz, Austria

esib is one of the biggest networking events for representatives from science, industry and politics in the field of industrial biotechnology. More than 500 attendees from all over the world are discussing scientific and industrial challenges. Meet peers, colleagues and friends and take the opportunity to get inspired for new project opportunities.

In 2024, esib will focus on “Sustainable Bioproduction” in the senses of bioeconomy and biopharma. In addition, the application of artificial intelligence in biotechnological approaches will be an important topic. Get an impression of esib by browsing the program.

More information

SusChem-AT Focus Day & CHASE Expert Days

19 -20 November 2024 | Vienna, Austria

The Expert Days are an excellent opportunity to discuss current topics on sustainability and technologies enabling the twin transition of the chemical industry in Europe together with the CHASE family. Learn all about the latest research projects and gain insights into our center’s work.

 SUSTAINABILITY DAY – 19 November 2024 in cooperation with SusChem-AT

 TECHNOLOGY DAY – 20 November 2024 in cooperation with EIT Manufacturing

The Expert Days will take place at the TUtheSky in Vienna.

We kindly ask you to register by 30 September 2024 at xpert@chasecenter.at

More information

Finally

We hope you enjoyed reading our BNN QUARTERLY! Please do not hesitate to contact us if you have any suggestions or feedback!

Our next BNN QUARTERLY will be published in December 2024 and will highlight Researchers on the Rise: Young Minds in Research & Development in the BioNanoNet community For this special issue, we are looking for nominations from our members for young researchers and contributors who are working hard to make a difference. Please send us your nomination and the nominee’s email address and we will contact them for an interview.

Please send all other QUARTERLY contributions to info@bnn.at by 5 December! Articles on other topics can be published any time on the BNN website.

All rights reserved. No part of this publication may be reproduced in any form without permission from the author or publisher. To request permission, contact info@bnn.at.

The BNN team from left to right: Johanna, Barbara, Caitlin, Beatriz, Christina, Simone, Clemens, Susanne, Andreas, Julia, Christine, Daniel, Angelika and Salja