We apply our experience and depth of industry knowledge to help you to navigate the challenges of new product development, scale-up, manufacturing and market release while minimising risks and meeting regulatory criteria accurately. At our GLP/GMP Biologics Centre of Excellence (Manchester, UK) we are adept at applying advanced technology in GMP analytical development programs, providing world-class structural analysis, physico-chemical properties and potency testing supporting biologic drug product characterization packages, quality control, stability or batch release.
• Clinical/preclinical bioanalysis (PK, ADA, Nab) and biomarker solutions
• Structural characterisation and physicochemical properties (ICH Q6B)
• Method development / validation and GMP analysis
• ICH stability programs
• Virology assay and identification