Small-Scale to Commercial: Can One US Peptide CDMO Scale With You?
Small-Scale to Commercial: Can One US Peptide CDMO Scale With You? Read More »
How to Choose a Peptide CDMO: A Sponsor’s Evaluation Checklist for Synthesis, Scale-Up, and Quality
Introduction How to Choose a Peptide CDMO? Sponsoring organizations must perform a comprehensive technical audit that assesses chemical synthesis platforms,
How Long Does Generic Drug Development Take at a CDMO? Timeline Expectations Explained
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 »
Peptide Technology Transfer: A Sponsor’s Step-by-Step Guide to Moving Programs Between CDMOs
CDMO Technology Transfer Peptide Technology Transfer: A Sponsor’s Step-by-Step Guide to Moving Programs Between CDMOs By Anusha Sinha • July
Peptide-Related Impurities and Degradation: ICH Q3A/Q3B Considerations Unique to Peptide APIs
Introduction Synthetic peptide active pharmaceutical ingredients (APIs) present unique regulatory and analytical challenges because conventional International Council for Harmonisation (ICH)
Canadian vs. US Peptide CDMOs: Which Is Right for Your Program?
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 CDMO vs. CMO: Which Does Your Program Actually Need?
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 »
How to Choose a Peptide CDMO in the US: A Buyer’s Checklist
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 »
Cross-Border Drug Development: One Testing Lab for Both FDA and Health Canada Submissions
Introduction: Sponsors developing a drug for the North American market almost always end up filing in both the United States
Peptide API Scale-Up: From Milligram Discovery Batches to Kilogram GMP Production
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 »