Viral Safety by Design for Cell and Gene Therapy Products
16th October 2020 | 10:00 am EST | Mark Plavsic, Chief Technology Officer at Lysogene and Dr. Magali Roche, Sales Manager, PathoQuest, Biologics Genomic Service |WATCH FOR FREE
Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C>) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose a constant risk to these biologics, and, as such, they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C> product manufacturing process to mitigate the risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
Presented by Mark Plavsic, Chief Technology Officer at Lysogene
Mark is Chief Technology Officer at Lysogene, a late stage clinical development gene therapy company with headquarters in Paris, France. Prior to joining Lysogene, Mark was SVP of Process Development & Manufacturing at Torque Therapeutics, Inc., an immuno-oncology company located in Cambridge, MA. Prior to joining Torque, Mark served as Head of Product Biosafety at Genzyme/Sanofi responsible for process improvements and bio-safety of biological products and associated manufacturing processes. Previously, Mark was in charge of gene therapy development at Genzyme, overseeing the upstream, downstream, formulation and analytical developments of viral vectors used in gene therapy applications. Prior to Genzyme, Mark held senior positions with AstraZeneca, Q-One Biotech, and Life Technologies, Inc. Mark’s technical experience spans across a wide spectrum of drug development and manufacturing activities, including raw materials, R&D, QC testing, GLP non-clinical studies, process development, GMP manufacturing, GMP contract testing, and GMP contract manufacturing.
Mark’s education includes a doctor of veterinary medicine (DVM) degree, MSc, and PhD degree in virology and immunology.
Followed by Next-generation sequencing for fast and performant results applied to cell and gene therapy products.
Presented by Dr. Magali Roche, Sales Manager, PathoQuest, Biologics Genomic Service
After graduating from the higher national engineering institute Ecole Normale Supérieur and receiving her Doctorate Degree in genetics and molecular biology, obtained with honors from the Cancer Research Center of Lyon, Dr Magali Roche started her career in the biologics industry at ViroScan3D where she developed a strong expertise in genomic as Project Manager for the R&D services. She then moved to a Sales specialist role at NuGEN Technologies (now Tecan Genomics) where she has assessed her strong expertise in next generation sequencing (NGS) for infectious diseases applications.
In her current role at PathoQuest, she is in charge of developing and driving the global sales strategy of the Biologics genomic service with a special focus on Europe and North America.
Sponsored by Pathoquest
Robust and efficient Quality Control testing is critical for the development of biologics in order to reduce time to market and improve patient outcomes.
Developers and producers need QC testing solutions that help de-risk their product development pipeline by preventing adventitious agent contamination and cell lines misidentification.
To meet those objectives, PathoQuest offers advanced Next Generation Sequencing (NGS) solutions that supplement or replace traditional methods and support the strategic decision-making process. This innovative approach allows for a robust and unambiguous level of testing and for faster turnaround time and is available with GLP grade.