This presentation has been recorded during BPI EUROPE Digital Week 2021.
With multiple products approved and commercialized, gene therapy has now gone beyond proof of concept and entered mainstream healthcare. This success urgently requires work on manufacturing processes to ensure that gene therapies are widely available to all that need them. Pall’s Accelerator℠ process development services help our customers develop reproducible and scalable processes for viral vector manufacturing in order to meet clinical and commercial market demand in very short timelines. We will outline how we work with our customers in providing this service, and present case studies of Adeno-Associated Virus (AAV) and Lentivirus (LV) production using adherent and suspension cell culture. Furthermore, we will present how we can also help our customers build their production facility with virtual reality through our Accelerator Vision platform.
GT Strategic Technology Partnership Leader
Emmanuelle has more than 13 years of experience in Biotechnology Process Development and GMP production. Highly skilled in the field of cell culture applications, Emmanuelle joined Pall Corporation nearly 10 years ago as Bioprocess Specialist (BPS). After four years in that role, she then transitioned to the Bioreactor Applications team, where she became Principal Bioreactor Specialist. In February 2021 she moved to her current role. Prior to Pall, Emmanuelle worked as Biotech Process Sciences Upstream Process development engineer at Merck Serono for 4 years. She received her Biotechnology Engineer diploma from the former Ecole Supérieure d’Ingénieurs de Luminy (now Polytech Marseille).
Why the introduction of X-ray sterilization technology is a critical change for single-use industry, and how gamma and X-ray irradiation compare
The market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.
Join Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD of Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology.
You will learn more about:
- Why this is a critical change for industry and the responsibilities of each stakeholder
- Key questions to address for biomanufacturers
- How gamma and X-ray irradiation compare
- What testing has been completed and key milestones for readiness for industry
- An example of how to qualify a SUS sterilized with X-ray irradiation