Alain Pralong, PhD
Alain brings more than 20 years of global experience in the biopharmaceutical industry, with expertise in gene therapy, therapeutic proteins, vaccines and cell therapy. During his career, Alain has played key roles in building manufacturing and quality organizations and overseeing process development up to launch, commercial manufacturing, and technical life cycle management.
Alain most recently served as Head of Manufacturing Process and Development at AgenTus Therapeutics, where he held responsibility for manufacturing two cell therapy programs, both entering into Phase 1 clinical development. Prior to joining AgenTus, Alain held a number of roles increasing in seniority at Schering-Plough, Roche, Merck-Serono, Crucell, GlaxoSmithKline, Cell Medica, and AMAL Therapeutics, where he served as Chief Operating Officer. During his tenure at Cell Medica, Alain led the development of cell therapy products for phase II clinical trials in oncology and the manufacturing of immune reconstitutions products to treat CMV and AdV infections post transplantation. At AMAL, Alain set up external manufacturing networks for phase I clinical studies for a therapeutic cancer vaccine. When working at Agentus Therapeutics, Alain led development of a CAR-T and an iNKT based cell therapy products. Since 2020, Alain works full-time as an independent consultant supporting clients in development biopharmaceutical and cell & gene therapy products in CMC, QA, and some RA activities.
Alain has also contributed several chapters to textbooks in the field, holds a Ph.D. in Molecular and Cell Biology from the University of Berne, Switzerland.
Alain is chairing the ASTM E55.91 workgroup and has been listed in the 100 most influential people in biopharmaceutical industry issued by The Medicine Maker.
Alain is also Associate Professor at the University Marseille, France, teaching Bioprocess Industrialization and Quality to bioprocess engineering students at the Polytech.
Alain serves also on three Scientific Advisory Boards.
- Koch A., Wittische-Laroche C., De Roo E., and Pralong A. (2006). Use of disposable technology in biologics manufacture. American Pharmaceutical Review: Nov-Dec issue
- Foulon A., Trach F., Pralong A., Proctor M., and Lim J. (2008). Cost-effectiveness study on disposable technology used in the transfer of an antibody manufacturing process between two production sites, BioProcess International, Volume 6 Issue 6, pages 12-17, June 2008
- Ravisé A., Cameau E., De Abreu G., and Pralong A. (2010). Hybrid and Disposable Facilities for Manufacturing of Biopharmaceuticals: Pros and Cons. Biochemical Engineering/Biotechnology, Volume 115, pages 185-219
- Luitjens A. and Pralong A. (2011). Going Fully Disposable – Current Possibilities: A Case Study from Crucell, Single-use Technology in Biopharmaceutical Manufacturing, 1st Edition, pages 341-349. Wiley ISBN: 978-0-470-43351-5
- Pralong A. interviewed by Koberstein W. (2011) Securing Supply In Single-Use Systems – The Second Source Decision. Life Science Leader Magazine, November 2011, pages 32-34. Published online on http://lifescienceleadermag.epubxp.com/i/46337/35
- Luitjens A., Lewis J.A., and Pralong A. (2012). Single-Use Biotechnologies and Modular Manufacturing Environments Invite Paradigm Shifts in Bioprocess Development and Biopharmaceutical Manufacturing, Biopharmaceutical Production Technology, pages 817-857. Wiley-VCH ISBN: 9783527330294
- Galliher P. and Pralong A. (2013). When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing Paradigm. BioPharm International Supplements: Volume 26, Issue 4, pages s27-s30
- Pralong, A., Levine, H. L., Lilja, J., Gaasvik, Å. and Hummel, H. (2014), Paradigm shift for vaccine manufacturing facilities: The next generation of flexible, modular facilities. Eng. Life Sci., 14: 244–253. doi: 10.1002/elsc.201400027
- Pralong, A. (2014), Standards for Single-Use Technology – A Must for Success. BioPharm Asia: Volume 3, Issue 3
- Pralong, A (2014) Overlooking GMP Biopharm Education/Training Can Cost You – Big Time. Life Science Leader Magazine article / December 2014: Published online on http://www.lifescienceleader.com/doc/overlooking-gmp-biopharm-education-training-can-cost-you-big-time-0001
- David J. Pollard, Alain Pralong (2018). Single-Use Technology Implementation for Biologics and Vaccines Production Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes, 1st Edition; pages 721-738. Elsevier ISBN: 978-0-08-100623-8
- Alain Pralong and Angélique Palumbo (2019). Single-Use Technologies Used in Cell and Gene Therapy Manufacturing Need to Fulfill Higher and Novel Requirements: How Can this Challenge Be Addressed?; Single-Use Technology in Biopharmaceutical Manufacture , 2nd Edition; pages 319-325. Wiley ISBN: 9781119477839