Introduction: For sponsors planning an Abbreviated New Drug Application (ANDA) or Abbreviated New Drug Submission (ANDS), one of the first […]
How Long Does Generic Drug Development Take at a CDMO? Timeline Expectations Explained Read More »
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,
Canadian vs. US Peptide CDMOs: Which Is Right for Your Program? Read More »
Peptide Manufacturing Strategy Peptide CDMO vs. CMO: Which Does Your Program Actually Need? By Anusha Sinha • July 22, 2026
Peptide CDMO vs. CMO: Which Does Your Program Actually Need? Read More »
Introduction Choosing a peptide Contract Development and Manufacturing Organization (CDMO) in the US requires a comprehensive assessment of technical synthesis
How to Choose a Peptide CDMO in the US: A Buyer’s Checklist Read More »
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 API Scale-Up: From Milligram Discovery Batches to Kilogram GMP Production Read More »
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
