Sawyer Chen (Siyu)

Primera Analytical Solutions is a GLP and GMP CRO in great standing with the FDA. Our primary objectives are quality and to become a trusted partner. Services include: - Large and small molecule CMC, bioanalytical, release testing. Method development/validation, method transfer (Assay, Impurities, Dissolution, PK/PD, ADA, cell-based/non cell-based NAb) - Cell & Gene Therapy (FACS, qPCR, ddPCR, cell-based assays - Cell potency assays - Impurity studies (LC/MS/MS, GC/MS, ICP/MS) - Extractable and leachable studies - Stability studies - Dissolution - Abuse-deterrent studies - Solid state characterization - Product and raw material release testing - Metabolite characterization, bioavailability and bioequivalence studies - Bioassay method development and validation - Impurities by ELISA - Peptide mapping - HRMS