Article
Cell Therapy CMC — Why the Module 3 Architecture for SM Will Fail Your CBER Reviewer
Cell therapy CMC packages fail at CBER not because the science is wrong, but because the regulatory architecture is borrowed from the wrong framework.
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Article
Cell Therapy CMC — Why the Module 3 Architecture for SM Will Fail Your CBER Reviewer
Cell therapy CMC packages fail at CBER not because the science is wrong, but because the regulatory architecture is borrowed from the wrong framework.
Article
FY2025 Enforcement Signals and 2026 CMC Regulatory Intelligence: Turning a Dated Year-in-Review Into a Forward CMC Risk Register
A year-in-review article is most valuable when it remains explicitly dated. Its purpose is not to pretend that FY2025 is current forever; it is to preserve the enforcement…
Article
GT Post-Approval Lifecycle — Long-Term Follow-Up, Registry Studies, and the Post-BLA CMC Commitment Architecture
The approval of a gene therapy BLA does not end the regulatory program — it begins the most operationally complex phase. A company with an approved AAV gene…
Article
Conference Intelligence — PDA-FDA Joint Regulatory Conference, Cell and Gene Therapy CMC Framework
Three weeks after the PDA/FDA Joint Regulatory Conference closed at the Westin DC Downtown in Washington, DC (September 14–16, 2026), the most operationally consequential CMC signal for the…
Article
In Vivo Genome Editing Drug Products — CBER Regulatory Strategy for Direct In Vivo Patient Administration
In vivo genome editing programs face a safety characterization challenge that ex vivo programs do not: when the editing machinery is delivered directly to the patient, every tissue…
Article
XGene CMC Consulting Intelligence — The Ten Questions Every CMC Program Must Answer Before IND
FDA places a meaningful share of INDs on clinical hold each year — roughly 10-20% depending on modality, with cell and gene therapy programs trending toward the higher…
Article
Epigenome Editing Drug Products — CMC Regulatory Considerations for CRISPR-dCas9 Epigenetic Platforms
Epigenome editing programs often make their first regulatory mistake before the IND CMC package is drafted — by assuming that because dCas9 does not cut DNA, the CMC…
Article
AI in Drug Manufacturing CMC — Emerging Technology Application
FDA's draft guidance "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products," published January 7, 2025, was the first document from…
Article
Base Editing and Prime Editing CMC — Precision Genome Editing Drug Products Beyond Double-Strand Break
Base editing and prime editing programs routinely receive the description "next-generation CRISPR" — a framing that creates a specific CMC regulatory trap. The CRISPR-Cas9 double-strand break framework that…
Article
FDA Expedited Programs — CMC Implications of RPDD, PDUFA, and Rare Pediatric Priority Review
Rare Pediatric Disease Designation is pursued primarily for the Priority Review Voucher — a tradeable asset that has sold for $100 million or more, with the program recently…
Article
CRISPR Delivery CMC — LNP, AAV, and RNP Delivery Systems for Genome Editing Drug Products
Every CRISPR delivery decision is presented as a biology question: which system delivers the editing machinery to the target tissue with the highest efficiency and lowest immunogenicity? It…
Article
Reference Product Selection for Complex Drug Products — CMC Evidence for Hybrid Applications
Reference product selection is the first CMC decision in a 505(b)(2) NDA or biosimilar BLA, and it is the decision with the highest correction cost if wrong. Selecting…
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