Why Cell & Gene Therapy Manufacturing Needs Two People to Do One Job with Steven Keizer
Update: 2025-07-30
Description
Ever wonder why cell and gene therapy manufacturing is so expensive? CDMO veteran Steven Keizer (15+ years experience) reveals a shocking operational reality: these procedures literally require two people to do what should be a one-person job.
In this episode, Steven breaks down:
- Why sterile manufacturing forces operators to work with a dedicated scribe
- How this violates FDA documentation requirements (but is necessary for patient safety)
- The fundamental disconnect between R&D teams who want blank pages and operators who need templates
- When biotech companies should start thinking about tech transfer (hint: much earlier than you think)
- Quality by design principles that can save millions in failed engineering runs
Steven has worked across large pharma and CDMOs, giving him unique insight into both sides of the tech transfer equation. Whether you're scaling your first process or your tenth, this conversation will change how you think about documentation.
Key topics: Tech transfer, SOP documentation, cell and gene therapy, GMP manufacturing, quality by design, CDMO operations
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