New European immunochemistry laboratory will meet clients’ global demand for clinical development support
Intertek, the leading quality solutions provider to industries worldwide, has announced plans to open a new European immunochemistry laboratory for bioanalytical support of clients’ clinical and pre-clinical immunogenicity and pharmacokinetic (PK) studies for biologic medicines.
Operated from the Manchester biologics centre of excellence, this new 10,000 ft2 facility with temperature and humidity control will deliver world class scientific support to clients focused on clinical and pre-clinical development of biologic medicines such as monoclonal antibodies, proteins and biosimilars.
The expansion not only builds on the existing service at Manchester, but gives clients access to large molecule bioanalytical support in both Europe and the USA. This facility mirrors the Intertek San Diego immunochemistry facility, which was expanded last year, and will provide global clients with access to specific methods operated from both facilities, requiring no further local validation.
This expansion reflects the fast growth of the global biopharmaceutical market over the past decade and the predicted further growth in particular in the development of novel therapeutic antibodies. Accompanying this growth in the sector is also the fast growth of demand for outsourcing services, including bioanalytical support.
These biologic medicines provide a new class of therapeutics for those diseases previously treated with small-molecule drugs, as well as a type of novel treatment for those previously untreatable diseases.
'Expanding our large molecule bioanalytical capability in Europe enables us to be more responsive to the needs of our clients who increasingly seek global service support from regional locations,' said Chetan Parmar, Senior Vice President of Intertek Life Sciences.
Ashleigh Wake, Biopharmaceutical Services Leader, UK, said: 'This expansion will help meet many challenges that our clients face throughout increasingly complex biologic drug development. The clinical and pre-clinical bioassay capability complements our strengths in protein analysis and biological activity testing.'
Intertek has been providing Good Laboratory Practice (GLP) compliant bioanalytical services to global pharmaceutical clients supporting their preclinical and clinical studies and immunogenicity assessment for more than 20 years. Intertek also 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 across the globe.