Introduction: Biologics, including monoclonal antibodies (mAbs), recombinant proteins, enzymes, fusion proteins, and biosimilars, are structurally complex medicines whose quality depends […]
PTM and Glycosylation Analysis Services for Biologics Read More »
Introduction Therapeutic oligonucleotide manufacturing depends on Phosphoramidite Solid-Phase Synthesis to assemble custom single-stranded and double-stranded nucleic acid sequences at scales
Introduction A chemically synthesized protein may qualify for approval as a biosimilar under Section 351(k) of the Public Health Service
Introduction Understanding how the FDA reviews a 351(k) biosimilar application requires examining a risk-based evaluation framework designed to establish that
How FDA Reviews a 351(k) Biosimilar Application: Inside the Evaluation of the Evidence Read More »
Introduction: Biosimilar Reference Standard Characterization is the systematic analytical profiling that establishes the properties of reference materials used to evaluate
Biosimilar Reference Standard Development and Characterisation Service Read More »
Introduction Evaluating immunogenicity without a comparative efficacy trial relies on replacing Phase III clinical efficacy studies with orthogonal bioanalytical characterization,
Introduction The chemical synthesis of glycoproteins enables the precise, cell-free assembly of full-length, functional proteins containing uniform oligosaccharide chains. This
Chemical Synthesis of Glycoproteins: How Interferon β-1a Was Made Without Living Cells Read More »
Introduction The implementation of ICH Q7 for Peptide APIs establishes the essential regulatory framework and Good Manufacturing Practice (GMP) requirements
ICH Q7 for Peptide APIs: What GMP Really Means at Each Step of Peptide Synthesis Read More »
Introduction: Deriving an NDSRI Acceptable Intake Limit for a novel nitrosamine drug substance-related impurity with no existing toxicology data is
Introduction: A “reasonably expected” nitrosamine is one that your chemistry, process, materials or storage make plausible, and that judgment decides
