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08:30 - 09:00

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Showing of Streams
08:30 - 09:00 30 mins
Registration
09:00 - 16:00 420 mins
Info
Outsourcing 101 – Best Practises when Choosing your Manufacturing Partner
Workshop 1

This interactive workshop will cover the below topics:

When to make the decision to either insource or outsource?

  • When is the best time to make the decision on in sourcing vs. outsourcing?
  • What are the limitations of building your capabilities in house?
  • What are the benefits vs. the costs?
  • Pros and cons of both models
  • What is better for large vs. small companies?
  • What sort of bioprocess equipment makes sense for CMO’s opposed to therapeutic companies?
  • Enterprise solutions vs. ability to customise


09:00 - 16:00 420 mins
Info
Comparability for ATMPs
Workshop 2
  • Christopher Bravery - Principal Consultant, Advanced Biologicals Ltd.

Change is inevitable and necessary both in development and over the post-approval product lifecycle. Whenever changes are made it is necessary to confirm they do not adversely impact the quality and therefore safety and efficacy of the product; this requires data beyond meeting current specifications. With any biological product this is challenging, for cell, gene and tissue products that cannot be fully characterised the challenges are greater still. Concerns about comparability undertaken during development are common issues raised during review and often delay market approval or contribute to failure. This course explains what comparability is and how to develop a successful comparability protocol.

Workshop Learning Overview:

  • What is comparability?
  • Why is meeting existing specifications not comparability?
  • How do I apply the principles of comparability to highly variable products?
  • Case studies: Common mistakes with comparability and their consequences.
  • Interactive exercise: Spot the weaknesses and propose improvements to a worked comparability study.