Generic Drug Development CDMO

CDMO Technology Transfer Peptide Technology Transfer: A Sponsor’s Step-by-Step Guide to Moving Programs Between CDMOs By Anusha Sinha • July […]

Introduction Synthetic peptide active pharmaceutical ingredients (APIs) present unique regulatory and analytical challenges because conventional International Council for Harmonisation (ICH)

Peptide CDMO Selection Canadian vs. US Peptide CDMOs: Which Is Right for Your Program? By Anusha Sinha • July 22,

Peptide Manufacturing Strategy Peptide CDMO vs. CMO: Which Does Your Program Actually Need? By Anusha Sinha • July 22, 2026

Introduction Choosing a peptide Contract Development and Manufacturing Organization (CDMO) in the US requires a comprehensive assessment of technical synthesis

Introduction: Sponsors developing a drug for the North American market almost always end up filing in both the United States

Introduction Peptide API Scale-Up requires translating laboratory solid-phase synthesis into scalable, robust, and compliant current Good Manufacturing Practice (cGMP) processes

Peptide Formulation & Stability Peptide Drug Formulation Challenges: Lyophilization, Prefilled Syringes, and Injectable Stability By Anusha Sinha • July 20,

Introduction Global contract development and manufacturing organization (CDMO) capacity is under severe pressure because the unprecedented multi-ton demand for semaglutide

Introduction Developing therapeutic peptides within a regulated environment requires selecting a synthetic strategy that effectively balances chemical scalability with stringent