How Many Stability Batches Are Required for an ANDA Submission and How Long Must They Be Stored?
Introduction An Abbreviated New Drug Application (ANDA) submission requires stability data from a minimum of three primary exhibit batches, which […]
Custom Peptide Synthesis Services: What to Look for in a GMP Manufacturing Partner
Introduction Choosing an appropriate Good Manufacturing Practice (GMP) manufacturing partner for custom peptide synthesis services requires a detailed assessment of
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How CDMOs Support Abbreviated New Drug Submission (ANDS) for Health Canada Approval
Introduction: CDMO support for ANDS can provide generic drug sponsors with the scientific, analytical, manufacturing, and documentation capabilities needed to
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Case Study: EU Generic Drug Dossier Development and EMA Submission Support at a Canadian CDMO
Introduction Achieving an efficient EU Generic Drug Dossier Development and EMA Submission through a Canadian Contract Development and Manufacturing Organization
Charge Variant Analysis of Therapeutic Peptides: Capillary IEF, CE-SDS, and Ion Exchange Methods
Introduction Charge Variant Analysis of Therapeutic Peptides is a critical analytical framework for profiling, quantifying, and monitoring charged proteoforms and
Peptide-Oligonucleotide Conjugate Sequence Confirmation Strategies (MS/MS + Enzymatic Digestion)
Introduction Peptide-Oligonucleotide Conjugate Sequence Confirmation Strategies integrate multi-stage tandem mass spectrometry (MS/MS) with targeted enzymatic digestion to achieve comprehensive primary
Extractables and Leachables (E&L) Testing for Generic Injectable Drug Products at a CDMO
Introduction: Generic injectable manufacturers face a unique quality challenge: unlike oral or topical products, injectables can expose patients directly to
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NMR-Based Structural Elucidation of Peptide-Oligonucleotide Conjugates
Introduction NMR-Based Structural Elucidation provides a definitive analytical approach for determining the three-dimensional architecture, solution-state dynamics, and covalent linkage geometry
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Charge Variant Analysis Service for Biosimilars: icIEF, CEX, and What the Data Reveals
Introduction Implementing an advanced Charge Variant Analysis Service for Biosimilars generates the essential comparative analytical evidence required to establish structural
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Case Study: End-to-End Biosimilar Analytical Package for a Regulatory Submission — How a CRO Partnership Delivered a Complete ICH Q6B Dossier
Introduction A well-executed End-to-End Biosimilar Analytical Package establishes molecular comparability between a proposed biosimilar candidate and its reference product through