What Happens After a Complete Response Letter (CRL) for a Generic ANDA? CDMO Support Options
Introduction After the issuance of a Complete Response Letter (CRL) for a Generic ANDA, the applicant enters a critical regulatory […]
Do Peptide Drugs Require Special Containment and Handling at a CDMO?
Introduction Peptide drugs require highly specialized containment and handling measures at a contract development and manufacturing organization (CDMO) because their
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How to Choose a Peptide CDMO in Canada: A Buyer’s Checklist
Introduction Understanding How to Choose a Peptide CDMO in Canada requires biopharmaceutical companies to carefully assess a contract manufacturer’s regulatory
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Does Gamma Irradiation or Autoclaving Affect PLGA Molecular Weight and Drug Release?
Introduction: PLGA molecular weight and drug release are closely connected because polymer chain length controls water penetration, degradation, matrix erosion
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Reference Standards and Analytical Method Validation for Peptide-Oligonucleotide Conjugates
Introduction Developing robust Reference Standards and Analytical Method Validation strategies for peptide-oligonucleotide conjugates (POCs) is critical for establishing biopharmaceutical identity,
Case Study: How Charge Variant Profiling by icIEF Identified a Critical Comparability Failure in an Adalimumab Biosimilar Programme
Introduction Charge Variant Profiling by icIEF identified a critical comparability failure in an adalimumab biosimilar candidate by detecting an unacceptable
Case Study: Resolving an Out-of-Specification Impurity Result and Rescuing a Delayed Peptide Batch
Introduction Resolving an Out-of-Specification Impurity Result during therapeutic peptide manufacturing requires a systematic analytical and regulatory approach to identify the
Scale-Up Challenges in Injectable Steroid Manufacturing
Introduction: Injectable steroid manufacturing scale-up is one of the most technically demanding transitions in sterile parenteral drug development, because a
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Sample Preparation and Extraction Techniques for Nitrosamine Analysis: SPE, LLE, and Headspace Methods
Introduction: Nitrosamine sample preparation and extraction is the single most consequential step in generating defensible, low-level impurity data — get
Bioanalytical CRO Services for Gene Therapy and AAV-Based Drug Programs
Introduction: Bioanalytical CRO Services for Gene Therapy provide the specialized analytical support needed to measure therapeutic agents, biomarkers, biological responses,
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