Introduction Synthetic peptide active pharmaceutical ingredients (APIs) present unique regulatory and analytical challenges because conventional International Council for Harmonisation (ICH) […]
Introduction Nitrosamine Testing for Antibiotics and Beta-Lactam APIs is a specialized analytical mandate focused on the detection, identification, and quantification
Introduction Poly(lactic-co-glycolic acid) characterization provides the essential analytical data required to control degradation rates, optimize drug entrapment, and ensure batch-to-batch
Introduction: The CTD Format for Generic ANDA and ANDS Submissions plays a fundamental role in the successful approval of generic
What Is the Role of the CTD Format in Generic ANDA and ANDS? Read More »
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 Establishing structural equivalence through a specialized Disulfide Bond Mapping Service for Biosimilars is critical for verifying higher-order structural integrity,
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 »
