Introduction: The ICH guidelines for peptide-oligonucleotide conjugates give developers a scientifically justified framework, even though no single ICH guideline is […]
ICH Guidelines Applicable to Peptide-Oligonucleotide Conjugate Development 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: GIP/GLP-1 Dual Agonist Forced Degradation is an analytical strategy used to understand how a dual-receptor peptide therapeutic responds to
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: PLGA molecular weight and drug release are closely connected because polymer chain length controls water penetration, degradation, matrix erosion
Does Gamma Irradiation or Autoclaving Affect PLGA Molecular Weight and Drug Release? Read More »
Introduction Developing robust Reference Standards and Analytical Method Validation strategies for peptide-oligonucleotide conjugates (POCs) is critical for establishing biopharmaceutical identity,
