Introduction Analytical Characterization for 505(b)(2) Peptide Products provides the comprehensive physicochemical, structural, and functional profile required to establish product safety, […]
Introduction Peptide-Drug Conjugate (PDC) Characterization Services deliver specialized analytical testing that uses high-resolution mass spectrometry and liquid chromatography to confirm
Introduction: PLA nanoparticles for targeted cancer delivery are nanoscale polymeric carriers in which an anticancer compound is incorporated into biodegradable
Case Study: PLA Nanoparticle Formulation for Targeted Solid Tumour Oncology Delivery Read More »
Introduction The execution of GMP Release and ICH Stability Testing establishes the comprehensive analytical framework necessary to demonstrate that therapeutic
Introduction Counter-Ion Analysis Services for Peptide APIs provide essential quantitative determinations of non-peptidic ionic species—specifically trifluoroacetate (TFA), acetate, and chloride—that
Counter-Ion Analysis Services for Peptide APIs: TFA, Acetate and Chloride Quantification Read More »
Introduction Quantitative characterization of active pharmaceutical ingredients (APIs) requires accurate differentiation between total lyophilized mass and the true active drug
Net Peptide Content and Amino Acid Analysis Testing Services for Peptide APIs Read More »
Introduction: The ICH guidelines for peptide-oligonucleotide conjugates give developers a scientifically justified framework, even though no single ICH guideline is
ICH Guidelines Applicable to Peptide-Oligonucleotide Conjugate Development Read More »
Introduction Peptide characterization data produced by a Contract Research Organization (CRO) may be submitted to the U.S. Food and Drug
Can Peptide Characterization Data Generated by a CRO Be Submitted Directly to the FDA? Read More »
Introduction From a characterization perspective, synthetic vs recombinant peptide drug characterization differs primarily in the assessment of process-related impurity profiles,
Introduction A peptide purity testing report should be assessed as a comprehensive analytical record that establishes molecular identity, relative chromatographic
Do I Need a CRO, a CDMO, or Both for My Generic Injectable Program? Read More »
