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
Introduction Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) serves as a label-free biophysical approach for investigating peptide conformational dynamics, solvent accessibility, and
