Can primary packaging selection help mitigate particulate risks in cell and gene therapy manufacturing?

Sean Werner is the Chief Technology Officer of Cell Processing at BioLife Solutions, a leading provider of bioproduction tools and services to the cell and gene therapy and broader biopharma markets. BioLife acquired Sexton Biotechnologies in 2021 where Sean was President of the company known for providing processing and handling solutions for the CGT industry. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. Sean has previous experience filling various roles in the scientific, global regulatory, and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 23 years working in the life science industry, he has guided regenerative medicine research programs, pre-clinical and clinical testing and submission strategies leading to global commercialization of medical devices and bioprocessing tools and successful initiation of multi-national cell therapy clinical studies.

Stuart was awarded his PhD by the University of Birmingham in 2005, after which his group developed a program of immune-based therapies for liver disease and liver cancer. Whilst at the University of Birmingham, Stuart led the development of cell therapy, based around dendritic cell vaccination for primary liver cancer. Following this success, he directed the University’s GMP unit until leaving academia at the end of 2022.

Since then, Stuart has been operating as Chief Manufacturing and Development Officer of adthera bio, a newly formed commercial CDMO. adthera is positioning itself as the partner of choice for innovative, optimized-quality, high-technology, cell and gene therapy-focused development and manufacturing. adthera bio develops clients' cell therapy ideas and makes them into workable medical interventions for patients, all in a regulatory compliant and quality managed system, to get it right first time.

Josh Jendusa is a Program Manager for Cell and Gene Therapies at Xiogenix - a role he has held for the past two years. In his current capacity, he oversees Xiogenix's cellular-based testing program for their cell and gene therapy automation equipment, work heavily in product innovation for new developments, as well as lead internal consumable validation initiatives. He has a background in the biological sciences from Marquette University in Milwaukee, Wisconsin.