Standardising Fill and Finish from Downstream to Upstream Manufacturing for Advanced Therapies

Standardising Fill and Finish from Downstream to Upstream Manufacturing for Advanced Therapies

A recorded panel discussion from Advanced Therapies Connect, lead by Fresenius Kabi

Fresenius Kabi's Steven Binninger lead a panel discussing fill and finish for advanced therapies. Steven was joined by:
  • Pierre Heimendinger, VP Pharmaceutical Development, Sangamo
  • Brian Newsom, Director of Business Development, Cell Therapy, KBI Biopharma
  • Maria Bianchi, Medical Director Cell Processing Lab, Polyclinico Gemelli

This lively panel discussed the following:
  1. Standardisation for source material collection, fill and finish and control rate freeze is desired and needed
  2. Granting clinical site flexibility for fill and finish procedures while standardising specific attributes (e.g. tubing sets, fill volumes, DMSO used) can be an important route to rapid clinical site adoption
  3. Automation to drive standardisation and reliability for fill and finish and cryopreservation unit operations are opportunities for tool developers. These are also essentials for the scaling biotech to ensure consistency from one centre to the next

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