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by Víctor Garcia-Gragera, MSc, PhD Candidate
MATerials Engineering Group (GEMAT) at Institut Químic de Sarrià // Banc de Sang i Teixits
Barcelona
Spain

Presenters and chairs of the Early-Stage Professional (ESP) Oral Abstract Session at ISCT Europe 2024 Regional Meeting in Goteborg. From left to right: Víctor Garcia-Gragera (presenter and author of the article), Vincenzo di Cerbo (co-chair), Amina Agović (co-chair), Laura Baqué Vidal (presenter), Takahiro Asatsuma (presenter), Rahim Hirani (presenter), Pierre Springuel (presenter) and Agner Hernique Dorigo Hochuli (presenter)

I cannot help but starting this Telegraft by showing my love for ISCT Europe 2024. After some years of intense research in the context of my PhD thesis – and with still some months more to go – my attendance at the meeting was my first international communication. And I could not have asked for a better experience.

The whole event served as pure fuel to my motivation as a professional. I met experts in the field whom I had long read about as well as their PhD students, researchers with great communication skills, who are continuing their works in very creative and meaningful ways. All attendees were open to the spontaneous exchange of ideas, which led to productive discussions for our respective projects. Panellists and chairs were great at igniting the spark of doubt and curiosity – the starting point for any research – on many plenary sessions and roundtables while also showed some light on our achievements and the future of the ecosystem. An ecosystem which is highly nurtured by academia peers, regulators and industry delegates. That said, from an early-stage professional perspective, I believe these latter have the experience, knowledge, and motivation to help bridge our community more effectively. Despite the challenges of conflicts of interest and data non-disclosure, it would be valuable to explore new ways to encourage their participation, allowing them to engage even more proactively with all kinds of initiatives. Still, the experience and intensity of the meeting fully met my expectations.

With all this context in mind, I feel that the current situation of novel gene therapies, cell-based therapeutics in general and, per extension, Advanced Therapy Medicinal Products (ATMPs) is not only fuel for my development as a bioprocess engineer, but also for a new generation of bioprocessing. Fuel for both opportunities and growth. I may be biased due to my background; a BSc in Biotechnology and an MSc in Bioengineering, with experience as a bioprocess engineer, mainly associated with animal cells but also with microbial fermentation. Therefore, to provide some basis for my statement, it is important to start with the fundamentals.

What is a bioprocess? It is a set of operations which make use of microbial, animal, and plant cells, and components of cells such as enzymes, to manufacture products and/or treat wastes.[1] With this definition in mind, it becomes clear that the manufacturing processes for all CGTs are, in fact, bioprocesses. Therefore, when the sector questions how can we solve the scalability challenge, my immediate thought is that, from the earliest stages of therapy design, we should consider how the final product will be administered and adapt consequently the bioprocess to be as robust, reproducible and productive as possible. This applies to both bioreactors and non-controlled/non-monitored manufacturing platforms. Ultimately, increasing productivity directly translates into more affordable, and consequently, accessible therapies. This is why I strongly believe there is so much room for opportunities and growth with bioprocessing. Paraphrasing a colleague’s presentation precisely at the ISCT 2024 Europe Meeting, the knowledge to overcome this scalability challenge is already available. We have the technology which was developed over 40 years ago for monoclonal antibody production. And let me add, interferons, vaccines, hormones, clotting factors and many other biological medicines. What is stopping us from using all that technology to manufacture ATMPs? 

In addition to the complexity inherent in ATMP manufacturing, two other key factors hinder the application of established bioprocess technology. The first relates to the very purpose and aims of academic work. There is an inherent drive to trailblaze. To push boundaries. To generate disruptive knowledge and to design next-generation tools. In their turn, these new tools enable further knowledge discovery and nurture the exponential cycle of innovation. However, papers and patents, indicative of this innovation, are increasingly less likely to break with the past in ways that push science and technology in new directions.[2] This doesn't imply a decline in research quality; rather, it implies an important part of the research is still helping in consolidating previously acquired knowledge. This is particularly true for bioprocess development. When insulin or monoclonal antibody production were being explored for the first time, bioprocess development was also creating, combining and applying different technologies for the first time. It was the beginning of how recombinant production revolutionized whole sets of health conditions. Nowadays, despite its broad applicability to emerging therapies, much of bioprocess development contribution lies in optimizing and enabling manufacturing with pre-existent technology, which, unfortunately, may not seem as academically relevant due to being a less disruptive kind of research.

The second one has already been highlighted in many reports and is associated with a workforce shortage in CGT field.[3,4] This is quite a complex topic but I am partially optimistic due to my education’s specific case. Although I did not have a specific modulus focused on ATMPs or on how to file an application to a regulatory agency, I was lucky enough to receive information on the main products authorized by regulatory agencies and their associated legislation (good manufacturing practices, quality management system…). Moreover, specific courses and other advanced education training are available nowadays for those wanting to learn skills key to CGT manufacturing. Therefore, maybe what may be lacking is ways of engaging more directly with young professionals to join the CGT workforce after completing their respective training. In the end, I believe there are skills that can only be acquired when really working inside CGT. 

Nevertheless, to solve a little bit both of these situations, we can focus on the next generation of professionals’ priorities. For Gen Z (and millennials), having a sense of purpose in the workplace is one of the most relevant aspects when planning our careers.[5] Therefore, an effective way to attract talent is to ensure that potential candidates understand how they can make a meaningful contribution in their roles. Just as ISCT Europe has fuelled my own passions, putting manufacturing and bioprocessing in the spotlight, through career guidance, with specific CGT bioprocessing grants and recognitions or even by changing the way we connect manufacturing with academic research, could provide a long-term boost to the next generation’s interest in the field. It may take years to build strong connections between all the agents implicated and to gain trust from people who did not know about bioprocess previously. However, if we keep working towards advancing in CGT, being transparent and healthy about our ecosystem, while sharing the meaning behind all our efforts, the future, at least workforce-wise, should be assured.

In closing, I hope you can see sparks shining through in these lines. The same kind of spark that once ignited my passion for a career in bioprocessing and health has been continuously fuelled by events like ISCT Europe 2024. The same passion which led me to write these lines and which I also hope serves as a spark for future initiatives and fuels our collective drive for improvement. See you at the next ISCT meeting!

References

1. Doran, P. M. (2013). Bioprocess Development An Interdisciplinary Challenge Bioprocessing. In Bioprocess Engineering Principles. Elsevier. https://doi.org/10.1016/c2009-0-22348-8
2. Park, M., Leahey, E., & Funk, R. J. (2023). Papers and patents are becoming less disruptive over time. Nature, 613(7942), 138–144. https://doi.org/10.1038/s41586-022-05543-x
3. Vives, J., Sánchez-Guijo, F., Gnecchi, M., & Zwaginga, J. J. (2023). Cell and gene therapy workforce development: the role of the International Society for Cell & Gene Therapy (ISCT) in the creation of a sustainable and skilled workforce in Europe. Cytotherapy, 25(10), 1033–1036. https://doi.org/10.1016/j.jcyt.2023.06.006
4. Sanchez-Guijo, F., Vives, J., Ruggeri, A., Chabannon, C., Corbacioglu, S., Dolstra, H., Farge, D., Gagelmann, N., Horgan, C., Kuball, J., Neven, B., Rintala, T., Rocha, V., Sanchez-Ortega, I., Snowden, J. A., Zwaginga, J. J., Gnecchi, M., & Sureda, A. (2024). Current challenges in cell and gene therapy: a joint view from the European Committee of the International Society for Cell & Gene Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT). Cytotherapy, 26(7), 681–685. https://doi.org/10.1016/j.jcyt.2024.02.007
5. Deloitte. (2024). 2024 Gen Z and Millennial Survey.