Chemically Synthesized vs Recombinant Proteins: Can a Synthetic Copy Be Approved as a Biosimilar?
Introduction A chemically synthesized protein may qualify for approval as a biosimilar under Section 351(k) of the Public Health Service […]
How FDA Reviews a 351(k) Biosimilar Application: Inside the Evaluation of the Evidence
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 »
Biosimilar Reference Standard Development and Characterisation Service
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 »
Immunogenicity Without a Comparative Efficacy Trial: Where Biosimilar Immunogenicity Data Now Comes From
Introduction Evaluating immunogenicity without a comparative efficacy trial relies on replacing Phase III clinical efficacy studies with orthogonal bioanalytical characterization,
Chemical Synthesis of Glycoproteins: How Interferon β-1a Was Made Without Living Cells
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 »
ICH Q7 for Peptide APIs: What GMP Really Means at Each Step of Peptide Synthesis
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 »
How Do You Derive an Acceptable Intake Limit for a Novel NDSRI with No Existing Toxicology Data?
Introduction: Deriving an NDSRI Acceptable Intake Limit for a novel nitrosamine drug substance-related impurity with no existing toxicology data is
What Is a ‘Reasonably Expected’ Nitrosamine Under FDA’s Guidance and How Does It Affect Your Risk Assessment?
Introduction: A “reasonably expected” nitrosamine is one that your chemistry, process, materials or storage make plausible, and that judgment decides
Regulatory Starting Materials for Synthetic Peptides: How to Justify Them Under ICH Q11
Introduction Justifying Regulatory Starting Materials for Synthetic Peptides under the International Council for Harmonisation (ICH) Q11 guideline requires a robust
Regulatory Starting Materials for Synthetic Peptides: How to Justify Them Under ICH Q11 Read More »
Amino Acid Derivatives and Building Blocks: How Raw Material Quality Shapes Impurities in GMP Peptides
Introduction Establishing rigorous quality attributes for Amino Acid Derivatives and Building Blocks is one of the most critical factors in