Insights
Practical thinking on materials, quality, and manufacturing.
Not thought leadership for its own sake. These are the things I actually think about - written for the people who have to make decisions about them.
Materials qualification
A risk-based approach to single-use consumable qualification for cell therapy
What a qualification program actually looks like when you have 10+ suppliers and a filing deadline.
Regulatory
USP <665> is mandatory. Here's what that means for your single-use components.
What changed, what it means for E&L testing, and what you need to do if you haven't started.
CMC strategy
What I learned authoring CMC sections for an FDA-approved NDA
Practical lessons from taking Ermeza from formulation through successful FDA approval.
Supplier management
Phase-appropriate supplier qualification: stop over-engineering early and under-documenting late
The qualification you need at Phase I is different from commercial. Most companies get this wrong in both directions.
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