Introduction TFA Counterion Exchange and Salt Form Selection is a critical downstream unit operation in active pharmaceutical ingredient (API) manufacturing […]
TFA Counterion Exchange and Salt Form Selection in Peptide API Manufacturing Read More »
Introduction: NMR vs LC-MS for Peptide Characterization is not simply a question of choosing the more advanced instrument — it’s
Introduction Extractables and Leachables Testing for Peptide Injectables is an essential analytical prerequisite for assessing the chemical compatibility, physical stability,
Introduction A comprehensive Nitrosamine Risk Assessment for Peptide APIs examines the specific chemical pathways through which reactive secondary and tertiary
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
