Intertek Pharmaceutical Services
For over 20 years we have helped the world’s most innovative pharmaceutical and biopharmaceutical companies to navigate challenges of new product development, scale-up, manufacturing and market release. Our chemistry, manufacturing and controls (CMC) development strategies and Good Manufacturing Practice (GMP) laboratory services can play a key role in reaching your next milestone through regulatory-driven, phase-appropriate GMP analytical services. Our CMC laboratory services help to identify sources of risk early in development and provide sufficient information to help you meet the stringent regulatory requirements of development, registration and production. Our expertise ensures sufficient information for your filings through expert method development and validation, stability studies and GMP batch release testing. Our scientists are adept at applying advanced technology in GMP compliant analytical development programs
Our GLP/GMP Centre of Excellence in Blackley, Manchester, UK, offers world-class scientific support to clients focused on the development of biologic medicines and advanced therapy medicinal products (ATMP) including biosimilars, proteins, monoclonal antibodies, antibody-drug-conjugates, vaccines and cell and gene therapies. Our programs include protein structural analysis, physico-chemical properties and potency testing for use in product characterization packages, stability or batch release. From this facility, we are also able to offer bioanalysis, immunogenicity, biomarker studies, early-stage product characterization and biological activity testing.
Bringing quality and safety to life, we respond precisely to your needs with solutions that go beyond just testing to help you achieve Total Quality Assurance.