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Join Kevin Smyth as he presents on the Biopharma Cell and Gene Challenges and Solutions in an Ever-Evolving Regulatory Landscape at the PDA Asia Pacific office's Sterile Manufacturing Learning Week.

This presentation will cover the following topics:

  • Facility designs for ATMPS 1. Regulatory Compliance 2. Cross Contamination 3. Biosafety 4. Lean 5. Operational readiness 6. Operational excellence
  • Unit operations 1. Equipment design for commercial-scale production in a heavily regulated industry. 2. Automation - Robots and Collaborative-bots. Can we replace the human? 3. New unit operations and technologies – these need to be accommodated. 4. Closed processing and the use of Aseptic Isolators – what are the challenges? 5. Disruptive Technologies – what can we leverage from other sectors in Industry
  • Patient Safety 1. Sterile boundaries and aseptic processing. 2. Managing Risk 3. Quality by design 4. Supply chain challenges


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