Introduction A specialized Subvisible and Visible Particle Testing Service provides essential physical characterization and quality control data needed to establish […]
Subvisible and Visible Particle Testing Service for Biosimilars: MFI, RMM, and USP <788> Read More »
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 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 Neutralizing Antibody (NAb) Assays for Biosimilars evaluate the functional ability of anti-drug antibodies (ADAs) to inhibit the mechanism of
Introduction Pharmacodynamic Biomarkers in Biosimilar Development provide precise, quantitative measurements of a biological drug’s pharmacological activity and target engagement, enabling
Introduction Designing a Comparative PK Similarity Study for Biosimilars requires the strategic integration of sensitive population selection, rigorous bioequivalence metrics,
Introduction The adoption of the EMA Reflection Paper on a Tailored Clinical Approach introduces a modern regulatory strategy designed to
