Be Closed-Minded: Advantages of Closed-system Manufacturing of Cellular Therapies
Time: 2:00 pm
day: Day One AM
Details:
• Producing GMP-compliant and safe cell therapies requires robust sterility assurance as these products cannot be sterilized
• Mitigating product sterility risks has historically been done using biosafety cabinets in stringent cleanroom background environments
• Manufacturing cell therapies in Grade A/ISO5 at commercial scale is prohibitively expensive for broadly available patient access
• Leveraging functionally closed manufacturing processes enables production in a more cost-effective environment while maintaining sterility assurance
