Session Details

Quality & Operations Track Session 1 - Media Fills
Friday, September 13, 2019 07:30 AM - 08:30 AM
Ballroom B
Aseptic process simulation (media fills) is a mean to validate the aseptic process. Pharmaceutical drug production processes are generally short and standardized. Whereas Cellular Therapies processes are complex and long. For this reason, cellular therapies institutions have variable practices when it comes to media fills; some ignore this method of validation while others struggle to implement a meaningful approach. Those who try to implement media fills shoulder significant cost, which for small institutions could very well be detrimental for it risks their ability to manufacture.

This session will shed light on this subject, highlight the implications of implementing media fills on institutions’ ability to manufacture new products, and provide an insight as to what processes should be validated using this method.


Chair: Rosemarie Bell, B.App.Sc Micro/Biochem MASM, QIMR Berghofer Medical Research Institute/ Q-Gen Cell Therapeutics, Australia

Speakers:

Validation of Media Fills
Adrian Gee, PhD, Baylor College of Medicine, USA
Learning objectives:
• Understand how to validate Media Fills
• Understand how to perform Media Fills
• Data required for Validation of Media Fills

Media Fills: Aseptic Process Simulation for cell Therapy Products Manufacturing
Aisha Khan, MS, MBA, University of Miami, USA
Learning objectives:
Validation of aseptic processes is essential to ensuring the successful end result for manufacturers in cell therapy field.  This presentation includes a detailed overview:
•      Identify all the elements of a complete aseptic validation by defining aseptic boundary for cell/tissue processing
•      Define validation requirements and acceptance criteria for aseptic media fills
•      Open vs. closed processing steps including container closure integrity
•      Cryopreserved product vs. fresh product
•      Process scale-up and scale-out
•      Equipment cleaning and disinfecting
•      Environmental Monitoring
•      Sterility requirements
•      The methods for simulating an aseptic process for the various types of cell therapy products