Introduction Peptide Drug Master File (DMF) Preparation requires the development of a comprehensive Chemistry, Manufacturing, and Controls (CMC) technical dossier […]
Peptide Drug Master File (DMF) Preparation and Filing Support Read More »
Introduction: GMP Manufacturing of Peptide-Oligonucleotide Conjugates requires a manufacturing strategy that accounts for the distinct chemical and analytical characteristics of
GMP Manufacturing of Peptide-Oligonucleotide Conjugates: What to Expect from a CRO Read More »
Introduction: Choosing the right manufacturing partner can make or break a drug product’s journey from development to market. CDMO qualification
How to Qualify and Audit a CDMO Under FDA GMP and ICH Q10 Requirements Read More »
Introduction: FDA Sameness for Complex Generic Drugs is a scientific and regulatory assessment used to determine whether a proposed generic
Introduction: Choosing an FDA registered testing laboratory can look like a simple checkbox exercise, but the terminology around registration, approval,
Introduction: First-in-human peptide drug manufacturing is the process of developing, manufacturing, testing, documenting, and releasing a peptide drug substance or
Introduction Biopharmaceutical sponsors are increasingly reshoring active pharmaceutical ingredient (API) manufacturing through North American Peptide CDMO Services to address critical
North American Peptide CDMO Services: Why Sponsors Are Reshoring Peptide API Supply Read More »
Introduction Establishing a dependable Clinical Trial Material Supply for Peptide Programs requires a coordinated Chemistry, Manufacturing, and Controls (CMC) strategy
Introduction Comprehensive Peptide Stability Testing Services establish the chemical, physical, and microbiological quality characteristics of therapeutic peptides when stored under
Introduction: Technology Transfer to GMP CDMO is one of the most technically demanding steps in bringing a first-in-generic modified-release tablet
