A Practical Approach to Early-Phase CMC
Integrated, risk-based chemistry, manufacturing and controls strategies support early-phase development, writes Richard Chubb
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Integrated, risk-based chemistry, manufacturing and controls strategies support early-phase development, writes Richard Chubb
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October 22, 2026
5 min read
Rob DiCicco discusses how FDA–industry collaboration is helping sponsors rethink safety reporting, selective safety data collection, and pragmatic clinical trial design.
October 22, 2026
5 min read
Alcami’s Kerrie Powell, Senior VP of Sales, discusses the challenges of sterile biologics manufacturing and what sponsors should look for in a CDMO partner
October 20, 2026
4 min read
Regeneron Genetics Center’s Luca Lotta explains how population-scale genetic evidence can reveal more promising drug targets and open new possibilities for disease prevention
October 20, 2026
5 min read
John Wichelt discusses Kindeva’s Bridgeton facility, supporting injectable programs from clinical development through commercial manufacturing, and choosing a long-term fill-finish partner
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