Manufacturing· September 17, 2026 · 27 min read
Equipment Qualification Is Not Process Performance Qualification
By Ran Chen#CMC#Manufacturing#Manufacturing Capacity
Topic
Manufacturing Capacity
Drug substance, fill-finish, CDMO bottlenecks, inspections, tech transfer, and capacity as a commercial constraint.
Manufacturing· September 13, 2026 · 26 min read
A PPQ Protocol Is Not Commercial Batch Release: Stage 2 Versus Stage 3 Records
By Ran Chen#CMC#Manufacturing Capacity#Manufacturing
Manufacturing· September 8, 2026 · 23 min read
Starter-PN Compounding Discretion Is Not an Approved Drug or 503B CGMP Waiver
Manufacturing· September 7, 2026 · 28 min read
PreCheck's Type V Facility DMF Is Not a PAI, and a CDMO Seat Does Not Transfer CGMP
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Manufacturing· September 6, 2026 · 30 min read
Annex 1 CCS Is Not FDA's 2026 Packaging CCS, and Neither Replaces 2004 Aseptic Guidance
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Manufacturing· August 24, 2026 · 17 min read
FDA's ACTIMP Potency Guidance: Personalized Peptide and Neoantigen Lot Release
By Ran Chen#CMC#Manufacturing Capacity#Pipeline
Generics· August 21, 2026 · 17 min read
The Estradiol Patch Shortage: Reading FDA's Database Against ASHP Bulletins
By Ran Chen#Supply Chain#Generics#Orange Book
Deals· August 4, 2026 · 13 min read
Samsung Biologics' $1.8B PolyPeptide Deal: Peptide & GLP-1 Bet
By Ran Chen#Manufacturing Capacity#GLP-1#Manufacturing
Manufacturing· August 1, 2026 · 20 min read
FDA Warning Letters by the Numbers (2026): CDER Drug Enforcement Surge
Manufacturing· July 26, 2026 · 17 min read