When Do You Need NMR and When Is LC-MS Sufficient for Therapeutic Peptide Characterization?
Introduction: NMR vs LC-MS for Peptide Characterization is not simply a question of choosing the more advanced instrument — it’s […]
Extractables and Leachables Testing for Peptide Injectables: Syringes, Stoppers, and Single-Use Systems
Introduction Extractables and Leachables Testing for Peptide Injectables is an essential analytical prerequisite for assessing the chemical compatibility, physical stability,
Nitrosamine Risk Assessment for Peptide APIs and Drug Products: Where NDSRIs Actually Come From
Introduction A comprehensive Nitrosamine Risk Assessment for Peptide APIs examines the specific chemical pathways through which reactive secondary and tertiary
Peptide Drug Master File (DMF) Preparation and Filing Support
Introduction Peptide Drug Master File (DMF) Preparation requires the development of a comprehensive Chemistry, Manufacturing, and Controls (CMC) technical dossier
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GMP Manufacturing of Peptide-Oligonucleotide Conjugates: What to Expect from a CRO
Introduction: GMP Manufacturing of Peptide-Oligonucleotide Conjugates requires a manufacturing strategy that accounts for the distinct chemical and analytical characteristics of
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How to Qualify and Audit a CDMO Under FDA GMP and ICH Q10 Requirements
Introduction: Choosing the right manufacturing partner can make or break a drug product’s journey from development to market. CDMO qualification
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How Does the FDA Evaluate Sameness for Complex Generic Drug Products Such as Injectables and Topicals?
Introduction: FDA Sameness for Complex Generic Drugs is a scientific and regulatory assessment used to determine whether a proposed generic
FDA Registered Testing Laboratory: What Registration Actually Covers (and What It Doesn’t)
Introduction: Choosing an FDA registered testing laboratory can look like a simple checkbox exercise, but the terminology around registration, approval,
Case Study: Supporting a Virtual Biotech Through First-in-Human Peptide Drug Manufacturing
Introduction: First-in-human peptide drug manufacturing is the process of developing, manufacturing, testing, documenting, and releasing a peptide drug substance or
North American Peptide CDMO Services: Why Sponsors Are Reshoring Peptide API Supply
Introduction Biopharmaceutical sponsors are increasingly reshoring active pharmaceutical ingredient (API) manufacturing through North American Peptide CDMO Services to address critical
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