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Join Kevin Smyth as he presents "BioPharma Cell and Gene Therapy Challenges and Solutions in an Ever-Evolving Regulatory Landscape" on Tuesday, March 16 from 12:30 - 1:15 p.m. during the Live Panel Discussions and Q&A portion of the PDA Annual Conference.

This presentation will cover the following:

Facility designs for ATMPs

  • Regulatory compliance
  • Cross contamination
  • Biosafety
  • Lean
  • Operational readiness
  • Operational excellence

Unit operations

  • Equipment design for commercial-scale production in a heavily regulated industry
  • Automation: robots and collaborative-bots. Can we replace the human?
  • New unit operations and technologies: these need to be accommodated
  • Closed processing and the use of aseptic isolators: what are the challenges?
  • Disruptive technologies: what can we leverage from other sectors in the industry

Patient Safety

  • Sterile boundaries and aseptic processing
  • Managing risk
  • Quality by design
  • Supply chain challenges

The purpose of the presentation is to inform, challenge, share knowledge and encourage the audience to assess current practices and to ponder what we need to do to bring these life-changing medicines to as many people as possible without impacting patient safety.

The audience will learn:

  • The current state of the industry - where we are
  • Where we need to go
  • Guidance and pointers on how we get there

More information and registration can be found on the PDA website.

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