Sartorius Presentation: Ensuring Regulatory Compliance in Cell Therapies from Lab to Bedside
Wednesday, May 29, 2024 07:00 PM - 07:15 PM
Exhibit Hall - Theatre B
Global Showcase Presentation
Presenter
Cell-based therapies provide promising new opportunities to treat disease and offer hope to patients in need. Bringing a new treatment to market requires innovative and compliant solutions that can accelerate progress from the lab, all the way to the patient, safely and cost effectively.
During cell therapy research and manufacturing process development, it is crucial to prove that the science functions robustly and the process can be scaled up to the required production volumes. In the unique lab environment of cell therapy, it is equally important to maintain comprehensive and precise electronic records from the equipment used to produce the data in order to streamline regulatory submission and smooth the transition from R&D toward manufacturing.
This session will present solutions provided by Sartorius that can be used in a cell therapy workflow, with an emphasis on the 21 CFR Part 11 software modules that can be used to simplify compliance.
Session Objectives:
• Short introduction to 21 CFR Part 11
• Considerations for regulatory compliance in a cell therapy workflow
• Benefits of leveraging Sartorius instruments and software for cell therapy workflows from R&D to the clinic
- Terence Hui, MSc, Manager, Field Application Scientist (FAS), Sartorius, USA
Cell-based therapies provide promising new opportunities to treat disease and offer hope to patients in need. Bringing a new treatment to market requires innovative and compliant solutions that can accelerate progress from the lab, all the way to the patient, safely and cost effectively.
During cell therapy research and manufacturing process development, it is crucial to prove that the science functions robustly and the process can be scaled up to the required production volumes. In the unique lab environment of cell therapy, it is equally important to maintain comprehensive and precise electronic records from the equipment used to produce the data in order to streamline regulatory submission and smooth the transition from R&D toward manufacturing.
This session will present solutions provided by Sartorius that can be used in a cell therapy workflow, with an emphasis on the 21 CFR Part 11 software modules that can be used to simplify compliance.
Session Objectives:
• Short introduction to 21 CFR Part 11
• Considerations for regulatory compliance in a cell therapy workflow
• Benefits of leveraging Sartorius instruments and software for cell therapy workflows from R&D to the clinic
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