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Joaquim Vives, PhD, contributing editor
Banc de Sanf i Texitis
Barcelona, Spain

The  6th annual Bioprocessing Summit Europe brought together more than 500 bioproduction, analytical and formulation professionals to advance the manufacture, quality and control of biological, cell and gene-based therapies (CGT) in Barcelona, Spain on 14-16th March 2023. This series of meetings is organized by Cambridge Healthtech Institute and consists of a 3-day, 10-track meeting format under the motto “Practical Solutions for Today’s Bioprocess Challenges.” I found the programme quite relevant to CGT developers (Table 1), and unexpectedly, the meeting also provided me with a very personal and motivational message for all ISCT stakeholders.  

Upstream processing	Cell Culture and Bioproduction: Emerging Technologies, Improved Process Control, and New Opportunities Cell Line Development: New Technologies, Big Data Solutions, and Best Practices for Engineering Robust Cell Lines
Downstream processing	Advances in Recovery and Purification: Optimizing Downstream Processing, Reducing Costs, Accelerating Development Intensified and Continuous Processing: Improving Process Intensification, Monitoring, and Control
Gene therapy	Gene Therapy CMC and Analytics: Improving the Analysis, Control, and Quality of Gene Therapies Gene Therapy Manufacturing: Improving Viral Vector Production, Yield and Supply
Cell therapy	Cell Therapy Manufacturing: Optimise Scale-Up Strategies and Achieve Commercial Success Cell Therapy CMC and Analytics: Implementing New Technologies and Enhancing Analytical Strategies
Analytics and formulation	Analytics and Characterisation: Emerging Technologies for New Biotherapeutic Modalities and Improved Process Control Formulation and Stability: New Technologies, Big Data Tools, and Formulating New Modalities

Table 1. Parallel tracks of the 6th Bioprocessing Summit Europe in Barcelona, Spain.

In the pre-meeting “training seminars,” the organizers introduced key concepts on Bioprocessing and Design of Experiments (DoE), using real-life case studies, along with extensive coverage of the academic theory and background. I found it a very interesting initiative in line with current efforts made by scientific societies, like the ISCT, to contribute to the education and training of the new generation of CGT professionals.

It was an intense 3-day meeting with parallel tracks and lively discussions with delegates and vendors at the exhibitor’s hall, where major players in Advanced Therapy Medicinal Product (ATMP) development and manufacturing presented their solutions for bioprocess scale-up (e.g., bioreactors, automation), quality control,  and compliance with current regulations at all stages of product development and commercialization. I was invited to give a talk on the role of Blood, Tissue and Cell establishments (or BTCs) in supporting the development and manufacturing of CGT while realizing the strengths of these types of institutions that can effectively contribute to accelerating clinical translation and patient access to innovative therapies. On the grounds of blood and tissue procurement and processing, BTCs have gradually expanded operations using all types of substances of human origin (SoHO) in autologous and allogeneic clinical settings and further contributing to their substantial manipulation to produce advanced therapies (1, 2). In the case of CAR-T therapies, the hub-and-spoke organizational model implemented in our BTC has proven successful in managing the complexity of the workflow and diversity of stakeholders involved, from apheresis collection to distribution and infusion of the final product into patients (3). This strategy has been followed by both existing and new CAR T-cell therapies, avoiding inter-hospital variability, offering site technical qualification and providing highly skilled and experienced staff, thereby reducing the work and resources required for ready access to innovative therapies and improving the efficiency of the overall supply chain.

I was engaged in this and other discussions when, suddenly, a representative from one of the companies present at the exhibitor’s hall approached me with a huge smile, inquiring about our work with blood and its components. I noticed she was unable to conceal some nervousness, and soon I understood why. A few years back, she was transfused with several units of blood and today, she just wanted to tell me that she is alive (!) and how grateful she was to all the donors for their “gift”. She wanted me to say “Thank you” to all the professionals in Hospitals and BTCs for your continuous work to improve (and save) lives of people like her.  

And here we are, Telegrafters! 

I am sure this is the best place to express her gratitude aloud: THANK YOU!

References

1. Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. PubMed PMID: 25769789. Epub 2015/03/15. eng.

2. Querol S, Rubinstein P, Madrigal A. The wider perspective: cord blood banks and their future prospects. Br J Haematol. 2021 Nov;195(4):507-17. PubMed PMID: 33877692.

3. Fernandez-Sojo J, Delgadillo J, Vives J, Rodriguez L, Mendoza A, Azqueta C, et al. A hub-and-spoke model to deliver effective access to chimeric antigen receptor T-cell therapy in a public health network: the Catalan Blood and Tissue Bank experience. Cytotherapy. 2023 Jan;25(1):14-9. PubMed PMID: 36041984.