Manufacturing· September 14, 2026 · 29 min read
An OOS Result Is Not Confirmed Failure or a Field Alert
By Ran Chen#CMC#FDA#Manufacturing
Topic
Manufacturing
Drug substance and drug product manufacturing, facility inspections, CDMO partnerships, and supply chain operational execution.
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 25, 2026 · 15 min read
FDA's 2026 CCS Draft Replaces 1999 Packaging Guidance, Not Biosimilar Devices
By Ran Chen#CMC#Manufacturing#Combination Product
Pipeline· August 19, 2026 · 16 min read
INTerpath-001 Phase 3: Intismeran Autogene and Keytruda's Post-2028 Strategy
By Ran Chen#Pipeline#Clinical Evidence#Pivotal Trials
Manufacturing· August 7, 2026 · 18 min read
AI Dossier Governance Checklist: What DJ Fang's Benchmark Means for eCTD Teams
By Ran Chen#FDA Approval#Policy#Manufacturing
Manufacturing· August 5, 2026 · 21 min read
2026 oncology injectable shortage: ifosfamide, carboplatin & buy-and-bill
By Ran Chen#Supply Chain#Oncology#Manufacturing
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