Case Study: Nitrosamine Leachable Investigation in a Blister-Packaged Oral Solid Dosage Form
Introduction: Nitrosamine leachables in blister packaging have become one of the most closely scrutinized contamination pathways in oral solid dosage […]
Native Mass Spectrometry for Therapeutic Peptide Characterization: Non-Covalent Interactions and Complex Stoichiometry
Introduction The structural characterization of biomolecular assemblies increasingly depends on Native Mass Spectrometry for Therapeutic Peptide Characterization, as it enables
PLGA Microsphere Scale-Up Services: From Lab Bench to Pilot and GMP Manufacturing
Introduction Professional PLGA Microsphere Scale-Up Services provide the essential engineering, analytical, and manufacturing infrastructure needed to successfully transition complex poly(lactic-co-glycolic
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Nitrosamines from Excipients: How Common Pharmaceutical Excipients Contribute to Nitrosamine Formation Risk
Introduction Nitrosamines from Excipients primarily arise when trace levels of nitrite impurities present in inactive formulation components react with susceptible
Protein Binding and Free Fraction Measurement in Bioanalysis: Methods and Regulatory Expectations
Introduction Protein Binding and Free Fraction Measurement in Bioanalysis is a fundamental analytical process used to determine the concentration of
Extractables & Leachables (E&L) Testing for Biosimilar Drug Development: CRO Capabilities and Timelines
Introduction Extractables & Leachables (E&L) Testing for Biosimilar Drug Development is a highly specialized, risk-based analytical approach developed to detect,
Biosimilar Regulatory Dossier Structure: Building the CTD Module 3 Analytical Package
Introduction Developing a compliant Biosimilar Regulatory Dossier Structure demands an in-depth understanding of the sophisticated analytical expectations established by global
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Case Study: Comprehensive Analytical Characterisation of a Trastuzumab Biosimilar — From CQA Mapping to Comparability Package
Introduction: Trastuzumab biosimilar analytical characterization is the foundation on which any HER2-targeted biosimilar’s regulatory approval is built, since agencies require
Acidic Microenvironment from Poly(lactic-co-glycolic acid) (PLGA) Degradation: Impact on Protein and Peptide Stability and Mitigation Strategies
Introduction The formation of an acidic microenvironment during the degradation of poly(lactic-co-glycolic acid) (PLGA) matrices represents one of the most
ICH Q6B Guidelines for Biological Characterisation: What Every Biosimilar Developer Needs to Know
Introduction Implementing the ICH Q6B Guidelines for Biological Characterisation requires a comprehensive, multi-orthogonal analytical strategy to verify that a proposed