Introduction Counter-Ion Analysis Services for Peptide APIs provide essential quantitative determinations of non-peptidic ionic species—specifically trifluoroacetate (TFA), acetate, and chloride—that […]
Counter-Ion Analysis Services for Peptide APIs: TFA, Acetate and Chloride Quantification Read More »
Introduction Quantitative characterization of active pharmaceutical ingredients (APIs) requires accurate differentiation between total lyophilized mass and the true active drug
Net Peptide Content and Amino Acid Analysis Testing Services for Peptide APIs Read More »
Introduction Peptide characterization data produced by a Contract Research Organization (CRO) may be submitted to the U.S. Food and Drug
Can Peptide Characterization Data Generated by a CRO Be Submitted Directly to the FDA? Read More »
Introduction From a characterization perspective, synthetic vs recombinant peptide drug characterization differs primarily in the assessment of process-related impurity profiles,
Introduction A peptide purity testing report should be assessed as a comprehensive analytical record that establishes molecular identity, relative chromatographic
Do I Need a CRO, a CDMO, or Both for My Generic Injectable Program? Read More »
Introduction After the issuance of a Complete Response Letter (CRL) for a Generic ANDA, the applicant enters a critical regulatory
Introduction Peptide drugs require highly specialized containment and handling measures at a contract development and manufacturing organization (CDMO) because their
Do Peptide Drugs Require Special Containment and Handling at a CDMO? Read More »
Introduction Understanding How to Choose a Peptide CDMO in Canada requires biopharmaceutical companies to carefully assess a contract manufacturer’s regulatory
How to Choose a Peptide CDMO in Canada: A Buyer’s Checklist Read More »
Introduction Developing robust Reference Standards and Analytical Method Validation strategies for peptide-oligonucleotide conjugates (POCs) is critical for establishing biopharmaceutical identity,
Introduction Charge Variant Profiling by icIEF identified a critical comparability failure in an adalimumab biosimilar candidate by detecting an unacceptable
