Contamination Control Challenges Facing Cell Therapy Facilities
Contamination Control Challenges Facing Cell Therapy Facilities
17th April 2023 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | Conor McMorrow, Aseptic Lead, Cell Therapy at Takeda and Félix Montero-Julian, Scientific Director of Pharma Quality Control at bioMerieux |WATCH FOR FREE
The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one-size-fits-all approach cannot be taken. While individual challenges may not be unique to cell therapies,. The way they can impact cell therapy facilities can be unique, with additional considerations given the nature of cell therapy products and production methods. Each process and facility is unique, with some processes far removed from a traditional biologics facility and others that may be closely aligned with traditional production methods. The challenges outlined in the presentation relate to some aspects that are related to processes and materials that can be presented during cell therapy manufacturing. These include:
Shelf-life considerations for starting materials and finished products
Contamination control schemes for facilities and their importance in facilities.
Control of personnel and the “human aspect” of cleanroom control.
Conor McMorrow is an aseptic lead for Takeda Grange Castles Cell Therapy Facility. His role involves working across departments in the facility to support microbiology, contamination control, and aseptic practices. He has worked across multiple pharmaceutical production sectors, including oral solid dose, over-the-counter, sterile compounding, and traditional biologics, before his involvement in cell therapy. Previous roles included working within QC Microbiology Labs, Raw Material Chemistry Labs, and Sterile Compounding Sterility Assurance. Conor has worked within the traditional biologics start-up site, involved with lab set-up and equipment qualifications. Conor is currently completing a Masters in Biopharmaceutical Science with a focus on cell and gene therapy design and qualification. Outside of work, he keeps active through climbing, kayaking, surfing, and swimming.
Félix Montero-Julian, Scientific Director of Pharma Quality Control at BioMérieux
Félix is the Scientific Director of Pharma Quality Control at BioMérieux. Félix has over 25 years of experience in industrial and clinical diagnostics and previously served as the Chemunex R&D Director at BioMérieux. Félix graduated from the Autonomous Metropolitan University in Mexico as an Industrial Biochemistry Engineer and holds a Masters in Science and a PhD in Immunology from the Aix Marseille II University in France. Félix is a member of different scientific organizations (PDA, ISAC) and served as an expert in a panel for the development of compendial rapid sterility tests for the USP. Félix has been and continues to be extensively involved in the implementation and acceptance of rapid and alternative microbiological methods. He has authored more than 50 scientific publications in basic and applied immunology and microbiology and is an inventor of more than 6 patents on immune therapeutic approaches. He is a prominent speaker at congresses and conferences and a regular contributor to BioMérieux scientific whitepapers. Félix has extensive technical experience, including the development of in vitro diagnostic and research reagents and applications, cell and tissue culture systems, microbiology, alternative and rapid microbiological methods, sterility testing, mycoplasma detection, compendial methods, methods for blood bank testing, and the cell and gene therapy process.
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