Introduction: Oligonucleotide CDMO Services give drug developers a single, analytically grounded route from sequence design to GMP drug substance, and […]
Introduction: Peptide-Oligonucleotide Conjugation Yield Optimization is the systematic improvement of the reaction and recovery processes used to make a peptide-linked
Case Study: Improving Conjugation Yield in a Complex Peptide-Oligonucleotide Program Read More »
Introduction: Data Integrity at CDMOs: ALCOA+ and 21 CFR Part 11 is the foundation of trustworthy outsourced development and manufacturing,
Data Integrity at CDMOs: ALCOA+ Principles and 21 CFR Part 11 Expectations Read More »
Introduction: ICH Q3D elemental impurities risk assessment is a critical part of pharmaceutical quality management, because metals can enter drug
ICH Q3D Elemental Impurities Risk Assessment: How a CDMO Builds the Control Strategy Read More »
Introduction: Immunogenicity Risk Assessment of Peptide Impurities is a key part of pharmaceutical development whenever an unexpected impurity appears in
Case Study: Immunogenicity Risk Assessment of a New Impurity in a Generic Peptide ANDA Read More »
Introduction: Peptide Synthesis vs Protein Manufacturing is an important distinction in pharmaceutical development, biotechnology, and analytical science, and the two
Is Peptide Synthesis the Same as Protein Manufacturing? Read More »
Introduction: Clinical Trial Material Manufacturing for Phase I and II is a critical part of drug development because clinical studies
Clinical Trial Material Manufacturing at a CDMO: Phase I and II Supply Planning Read More »
Introduction Peptide Analytical Method Development and Validation is a critical component of peptide drug development because peptide molecules present analytical
Peptide Analytical Method Development and Validation Services under ICH Q2(R2) and Q14 Read More »
Introduction: Intact Mass Analysis and Middle-Up Characterization of Biosimilar mAbs are mass spectrometry-based approaches for evaluating the molecular identity and
Intact Mass Analysis and Middle-Up Characterisation Service for Biosimilar mAbs Read More »
Introduction: An Insulin Glargine Biosimilar PK Comparability Study is a core part of the evidence showing that a proposed insulin
