Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce the expansion of its centre of excellence for biopharmaceutical services in Manchester, UK, through an additional 14,000 ft² laboratory space supporting the development of biologics and gene therapies.
The current facility provides a broad range of Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) bioanalysis and analysis services to clients involved in the development and manufacture of pharmaceuticals and biologic medicines. The new facility is currently being commissioned and is expected to be formally opened in early 2020. This increased capacity includes temperature-controlled laboratories, leading-edge analytical technologies with recruitment of over 60 additional scientists, statisticians and regulatory project managers.
The increasing global growth of biologic and gene therapy development is improving patient access to new, effective and targeted therapies across many different indications including cancer, neurological disorders, infectious, and cardiac diseases. These therapies are complex, with challenging and highly regulated development processes; this drives the need for robust, advanced analysis expertise to assure drug safety and quality, thus expediting research and development, shortening time to market whilst maximizing clinical benefit.
Ashleigh Wake, Laboratory Director, said “As global demand grows for specialist contract laboratory services, particularly in the fields of biologics and gene therapy development, our latest expansion brings increased capacity and flexibility to help deliver solutions for our clients around the world enabling them to develop industry leading products adhering to evolving regulatory requirements.”
Graham Ritchie, Executive Vice President – Europe said “We are delighted to expand and invest in our centre of excellence for biopharmaceutical services in Manchester. The team has a strong heritage of supporting complex pharmaceutical product development through industry-leading analytical and regulatory expertise. This expansion advances our ability to help clients navigate the challenges of development programs for biologics or gene therapies through our systemic, end-to-end Total Quality Assurance solutions.”
Intertek provides pharmaceutical development and manufacturing support services spanning analysis, bioanalysis, formulation development, regulatory consultancy, auditing and supply chain management solutions from its network of offices and regulatory laboratories including Melbourn, near Cambridge (UK), Basel (Switzerland), San Diego (California, USA), Whitehouse, (New Jersey, USA) and Melbourne, (Australia).