Article
Neoantigen Cancer Vaccines — CMC for Personalized mRNA-LNP Cancer Vaccine Drug Products
Every patient's neoantigen cancer vaccine has a different mRNA sequence. There is no reference standard, because the reference is the patient's own tumor mutational profile — and no…
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Article
Neoantigen Cancer Vaccines — CMC for Personalized mRNA-LNP Cancer Vaccine Drug Products
Every patient's neoantigen cancer vaccine has a different mRNA sequence. There is no reference standard, because the reference is the patient's own tumor mutational profile — and no…
Article
3D Bioprinting and Scaffold-Based Drug Delivery — CMC for Combination Device-Drug Biofabricated Products
A 3D-bioprinted scaffold delivering a drug is not a drug product with a device delivery system bolted on. It is a combination product in which the scaffold material,…
Article
Microbiome Therapeutics — CMC Regulatory Framework for Live Biotherapeutic Products Under FDA
Vowst received FDA approval in April 2023 — the first orally administered microbiome therapeutic for C. difficile recurrence prevention. Rebyota was approved in November 2022 as the first…
Article
Oncolytic Virus Drug Products: Building CMC Under the Current FDA CBER OTP and EMA CAT Frameworks
Oncolytic viruses sit at an unusually demanding CMC intersection: the product must retain a defined viral identity and engineered genotype, reproduce consistently, express any therapeutic transgene as intended,…
Article
Base Editing and Prime Editing Drug Products — CMC at the Precision Genome Medicine Frontier Beyond CRISPR
A base editor is a deaminase fused to a Cas9 nickase. A prime editor is a reverse transcriptase fused to a Cas9 nickase. Neither requires a double-strand DNA…
Article
Circular RNA Therapeutics — CMC Emerging Considerations for This Novel RNA Therapeutic Modality
Circular RNA has no 5' cap. It has no poly(A) tail. The analytical methods validated for linear mRNA drug substance — capping efficiency by LC-MS/MS, poly(A) tail length…
Article
mRNA Capping and Modification Chemistry — CMC Control of Therapeutic mRNA Drug Substance Quality Attributes
Cap 1 mRNA is immunologically silent. Cap 0 mRNA triggers innate immune sensors. Uncapped mRNA does both — without the translational efficiency advantage. The ratio of cap 1…
Article
siRNA Drug Products Beyond LNPs — GalNAc Conjugate CMC from Alnylam Precedent to Your Program
Alnylam has four FDA-approved GalNAc-siRNA drugs. Their CMC frameworks are in FDA's review files. The FDA reviewer who evaluates your GalNAc-siRNA NDA will compare your CMC documentation to…
Article
Antisense Oligonucleotide CMC — Sequence-Specific Synthesis, Impurity Profile, and Specification Strategy
An ASO n-1 shortmer is not a typical process impurity. It is a pharmacologically active sequence-truncated version of your drug substance that differs from the full-length ASO by…
Article
PROTAC Drug Products — CMC Considerations for Heterobifunctional Targeted Protein Degraders
A PROTAC is a small molecule in the regulatory sense — it is not a biologic, it does not require a BLA, and it files as an NDA…
Article
Photodynamic Therapy Drug Products — CMC for Photosensitizer Drug Products Under CDER Complex Drug Product Review
A photosensitizer drug product's therapeutic mechanism depends on a photophysical event — absorption of light at a specific wavelength followed by energy transfer to molecular oxygen, generating the…
Article
PROTAC and Targeted Protein Degraders — CMC Considerations for This Novel Heterobifunctional Small Molecule Modality
PROTACs are classified as small molecules for regulatory purposes. This classification creates a CMC illusion: because the drug substance is not a biologic, the CMC team believes the…
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