Automating the final cell therapy bioprocess step for robust CMC/GMP compliance

Until recently, Tracy Moore worked with the Medicines and Healthcare products Regulatory Agency (MHRA) as an Expert Good Manufacturing Practice (GMP) Inspector, specializing in sterile products and data integrity. In the following article and interview, she draws on this experience to highlight:

• Regulatory considerations and requirements for GMP compliance when manufacturing advanced therapy medicinal products (ATMPs)
  
• How to identify specific gaps in compliance that may occur
• Common areas of weakness found upon inspection
• The potential benefits and pitfalls of open versus closed processes

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