How Do You Detect and Quantify D-Amino Acid Impurities in a Synthetic Therapeutic Peptide?
Introduction: D-Amino Acid Impurity Analysis in Peptides is the set of analytical procedures used to detect, locate, and quantify unwanted […]
Phase-Appropriate CMC Development at a CDMO: What Changes from Preclinical to Phase III
Introduction Phase-Appropriate CMC Development at a CDMO represents a risk-managed approach to scaling that aligns Chemistry, Manufacturing, and Controls activities
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Analytical Characterization for 505(b)(2) Peptide Products: Comparative Data to Bridge to the Listed Drug
Introduction Analytical Characterization for 505(b)(2) Peptide Products provides the comprehensive physicochemical, structural, and functional profile required to establish product safety,
Peptide-Drug Conjugate (PDC) Characterization Services: Conjugation Site, Payload Ratio and Linker Stability
Introduction Peptide-Drug Conjugate (PDC) Characterization Services deliver specialized analytical testing that uses high-resolution mass spectrometry and liquid chromatography to confirm
Case Study: PLA Nanoparticle Formulation for Targeted Solid Tumour Oncology Delivery
Introduction: PLA nanoparticles for targeted cancer delivery are nanoscale polymeric carriers in which an anticancer compound is incorporated into biodegradable
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GMP Release and ICH Stability Testing Services for Peptide Drug Substance and Drug Product
Introduction The execution of GMP Release and ICH Stability Testing establishes the comprehensive analytical framework necessary to demonstrate that therapeutic
Counter-Ion Analysis Services for Peptide APIs: TFA, Acetate and Chloride Quantification
Introduction Counter-Ion Analysis Services for Peptide APIs provide essential quantitative determinations of non-peptidic ionic species—specifically trifluoroacetate (TFA), acetate, and chloride—that
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Net Peptide Content and Amino Acid Analysis Testing Services for Peptide APIs
Introduction Quantitative characterization of active pharmaceutical ingredients (APIs) requires accurate differentiation between total lyophilized mass and the true active drug
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ICH Guidelines Applicable to Peptide-Oligonucleotide Conjugate Development
Introduction: The ICH guidelines for peptide-oligonucleotide conjugates give developers a scientifically justified framework, even though no single ICH guideline is
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Can Peptide Characterization Data Generated by a CRO Be Submitted Directly to the FDA?
Introduction Peptide characterization data produced by a Contract Research Organization (CRO) may be submitted to the U.S. Food and Drug
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