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In-depth writing on tech transfer, process validation, drug product, CDMO governance, and regulatory CMC for advanced therapies. Free to read, no login, no paywall.
- →Drug Product Advanced 48 min readBuilding a Container Closure Integrity Program Under USP <1207>
How to build a CCIT program that holds up in an inspection: deterministic versus probabilistic methods, matching the method to vials, prefilled syringes, and cryobags, validating the method itself, and testing at the right points across the lifecycle.
- →CDMO Governance Intermediate 34 min readDeviations and Change Control Across a CDMO Network: Who Really Owns What
How to run deviations, root cause investigations, CAPA effectiveness verification, and change control across a network of contract manufacturers, from what the quality agreement actually buys you to the metrics that reveal a partner's quality system drifting.
- →CDMO Governance Intermediate 60 min readTechnical Assessment of a CDMO Before You Sign
How to run the technical assessment, capability, capacity, culture, equipment fit, analytical readiness, and data systems, that turns CDMO selection into a defensible technical agreement instead of a leap of faith.
- →Regulatory CMC Advanced 45 min readCMC Validation Summaries for Regulatory Filings: Writing the Process Validation Story a Reviewer Can Follow
What INDs, NDAs, and BLAs actually require for process validation content, how to write S.2.5 and P.3.5 sections and PPQ summaries a reviewer can follow, and how to handle review-cycle questions and pre-approval inspection readiness.
- →Process Validation Intermediate 51 min readContinued Process Verification: Building a Stage 3 Program That Actually Monitors
How to build a Stage 3 CPV program that catches process drift before it becomes an OOS, covering parameter selection, control charts versus capability indices, escalation rules, and right-sizing for batch volume.
- →Drug Product Beginner 56 min readCold Chain for Advanced Therapies: Qualifying Cryoshippers and Dry-Vapor Shippers
How to qualify the cold chain for cell and gene therapies: shipper types, shipping study design, real-time monitoring and alert escalation, reverse logistics, customs and import contingency planning, and how a temperature excursion actually gets investigated.
- →Drug Product Intermediate 39 min readFilter Validation for Biologics and Oligonucleotides
How to build a sterilizing-grade filter validation package: bacterial retention studies with the manufacturer, product-specific versus matrix bracketing, the extractables handoff, routine integrity testing, and the traps that catch low-volume programs.
- →Drug Product Advanced 42 min readFormulation Development Patterns Across Advanced Therapies
How formulation logic shifts from proteins to oligonucleotides to cells to AAV vectors: stability drivers, excipient choices, custom cryoformulation development, mixing equipment selection, lyophilization cycle basics, and what changes at high concentration heading toward a prefilled syringe.
- →Process Validation Beginner 31 min readOne Validation Mindset, Six Modalities
What carries and what breaks when the same validation instinct moves from small molecule tablets through medical devices, RNAi-LNPs, oligonucleotides, autologous cell therapy, gene therapy, and now RNA editing.
- →Tech Transfer & NPI Beginner 49 min readPerson-in-Plant Oversight: What a PIP Is Actually For
Person-in-plant oversight at a CDMO: what to watch on the floor, virtual versus on-site models, and how to drive CAPA to closure without becoming the contractor's second QA unit.
- →Process Validation Advanced 43 min readPPQ Readiness: The Prerequisites That Decide Success Before Batch One
What Process Performance Qualification readiness actually requires: the process, analytical, documentation, and CDMO prerequisites that decide whether a PPQ campaign succeeds, checked before batch one starts.
- →Tech Transfer & NPI Intermediate 59 min readTechnology Transfer for Advanced Therapies: How a Transfer Actually Gets Done
How to run a technology transfer for cell, gene, and RNA therapeutics: the document spine, phase-appropriate rigor, engineering runs, and the handoff criteria that make a transfer actually done.
- →Process Validation Beginner 50 min readValidation Master Planning for a Clinical-Stage Biotech: Getting Started the Right Way
What a Validation Master Plan is for, how to scope it by risk instead of habit, and how to keep it a living document an inspector can actually follow.