Overcoming challenges early: Selecting equipment for CGT processes based on performance, qualification, cGMP compatibility, data monitoring, and flexibility.
Saturday, September 9, 2023 12:15 PM - 01:15 PM
Grand Ballroom L
Cell and gene therapy lab equipment choice can impact the quality of the final drug product. There are five criteria to evaluate with each lab equipment selection for CGT. They are:
• Performance
• Qualification
• cGMP compatibility
• Data monitoring
• Flexibility
Concrete examples and data will drive a discussion about equipment choice for CGT. Mary Kay Bates, Senior Global Cell Culture Scientist, and Wilfredo Marin, Senior Product Application Specialist Biobanking & Cryopreservation, both with Thermo Fisher Scientific, will share their experiences consulting with cell and gene therapy laboratories on product selection and overcoming challenges with existing manufacturing processes. Finally, they will provide examples of the data you should be asking for before purchasing lab equipment.
Session Objectives
• Performance
• Qualification
• cGMP compatibility
• Data monitoring
• Flexibility
Concrete examples and data will drive a discussion about equipment choice for CGT. Mary Kay Bates, Senior Global Cell Culture Scientist, and Wilfredo Marin, Senior Product Application Specialist Biobanking & Cryopreservation, both with Thermo Fisher Scientific, will share their experiences consulting with cell and gene therapy laboratories on product selection and overcoming challenges with existing manufacturing processes. Finally, they will provide examples of the data you should be asking for before purchasing lab equipment.
Session Objectives
- The five criteria for selecting equipment for cell and gene therapy processes.
- Which lab equipment do you have in your laboratory that you can use when transitioning into a cGMP environment?
- Common yet preventable challenges in therapy manufacturing related to lab equipment choice.
- What questions to ask when selecting lab equipment for cell and gene therapy processes.
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