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,
Introduction Charge Variant Profiling by icIEF identified a critical comparability failure in an adalimumab biosimilar candidate by detecting an unacceptable
Introduction Resolving an Out-of-Specification Impurity Result during therapeutic peptide manufacturing requires a systematic analytical and regulatory approach to identify the
Introduction: Injectable steroid manufacturing scale-up is one of the most technically demanding transitions in sterile parenteral drug development, because a
Scale-Up Challenges in Injectable Steroid Manufacturing Read More »
