Case Study: Resolving a Peptide Assay Discrepancy Using Amino Acid Analysis and Counter-Ion Testing
Introduction: A Peptide Assay Discrepancy Investigation is a systematic review that explains why two analytical results for the same peptide […]
Amino Acid Analysis by HPLC: How Acid Hydrolysis and AQC Derivatization Confirm Peptide Composition
Introduction Amino Acid Analysis by HPLC determines the precise amino acid composition and absolute peptide content of biopharmaceutical preparations through
Semaglutide Amino Acid Analysis: Composition Confirmation for GLP-1 Peptide Comparability and Vendor Qualification
Introduction Semaglutide Amino Acid Analysis is an essential quantitative characterization technique used to determine the precise stoichiometric molar ratios of
USP <665> Risk Assessment Explained: How to Classify Your Plastic Manufacturing Components and Avoid Unnecessary Extractables Testing
Introduction The USP Risk Assessment Explained framework provides biopharmaceutical manufacturers with a standardized, science-based methodology for classifying polymeric manufacturing components
Synthetic vs Recombinant Manufacturing of Long Peptides and Small Proteins: Choosing the Right Route
Introduction Evaluating Synthetic vs Recombinant Manufacturing for long peptides and small proteins requires balancing sequence length, non-canonical modifications, scale-up economics,
Subvisible and Visible Particle Testing Service for Biosimilars: MFI, RMM, and USP <788>
Introduction A specialized Subvisible and Visible Particle Testing Service provides essential physical characterization and quality control data needed to establish
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PTM and Glycosylation Analysis Services for Biologics
Introduction: Biologics, including monoclonal antibodies (mAbs), recombinant proteins, enzymes, fusion proteins, and biosimilars, are structurally complex medicines whose quality depends
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Phosphoramidite Solid-Phase Synthesis: How Therapeutic Oligonucleotides Are Manufactured at Scale
Introduction Therapeutic oligonucleotide manufacturing depends on Phosphoramidite Solid-Phase Synthesis to assemble custom single-stranded and double-stranded nucleic acid sequences at scales
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
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