Introduction Choosing an appropriate Good Manufacturing Practice (GMP) manufacturing partner for custom peptide synthesis services requires a detailed assessment of […]
Custom Peptide Synthesis Services: What to Look for in a GMP Manufacturing Partner Read More »
Introduction: CDMO support for ANDS can provide generic drug sponsors with the scientific, analytical, manufacturing, and documentation capabilities needed to
How CDMOs Support Abbreviated New Drug Submission (ANDS) for Health Canada Approval Read More »
Introduction Achieving an efficient EU Generic Drug Dossier Development and EMA Submission through a Canadian Contract Development and Manufacturing Organization
Introduction Charge Variant Analysis of Therapeutic Peptides is a critical analytical framework for profiling, quantifying, and monitoring charged proteoforms and
Introduction Peptide-Oligonucleotide Conjugate Sequence Confirmation Strategies integrate multi-stage tandem mass spectrometry (MS/MS) with targeted enzymatic digestion to achieve comprehensive primary
Introduction: Generic injectable manufacturers face a unique quality challenge: unlike oral or topical products, injectables can expose patients directly to
Extractables and Leachables (E&L) Testing for Generic Injectable Drug Products at a CDMO Read More »
Introduction NMR-Based Structural Elucidation provides a definitive analytical approach for determining the three-dimensional architecture, solution-state dynamics, and covalent linkage geometry
NMR-Based Structural Elucidation of Peptide-Oligonucleotide Conjugates Read More »
Introduction Implementing an advanced Charge Variant Analysis Service for Biosimilars generates the essential comparative analytical evidence required to establish structural
Charge Variant Analysis Service for Biosimilars: icIEF, CEX, and What the Data Reveals Read More »
Introduction A well-executed End-to-End Biosimilar Analytical Package establishes molecular comparability between a proposed biosimilar candidate and its reference product through
Introduction Chiral Purity Testing and D-Amino Acid Quantification in a synthetic octapeptide active pharmaceutical ingredient (API) requires high-resolution liquid chromatography
