Biopharmaceuticals are a rapidly growing sector of the pharmaceutical industry with over 80 biologic drugs now approved for clinical use. More than 30% of all new pharmaceuticals in development are biologics. These drugs provide effective new treatments for a wide range of diseases. Analytically they present a unique set of challenges. Novel methodologies are required to measure drug potency, pharmacokinetics and biodistribution, patient responses and product efficacy, and these all require development and validation in order to satisfy regulatory requirements.

BioAnaLab was established in 2002 to provide these services based on the experience of its founders at the University of Oxford where they had developed a large number of therapeutic monoclonal antibodies, including CAMPATH®. This involved the development, validation and use of novel assays to measure serum concentrations of monoclonal antibodies and antibody responses.

Since then the company has grown rapidly and now has a substantial team of experienced scientists. We offer analytical services for all protein-based therapeutics such as vaccines, monoclonal antibodies, cytokines, growth factors, enzymes, hormones, etc...

BioAnaLab is a member of the GLP compliance monitoring scheme and is accredited by the UK MHRA to carry out analytical work meeting the requirements of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) as required. All projects, whether early stage research and development, assay transfer, validation or sample analysis to support clinical trials or post-marketing commitments, are carried out under our comprehensive Quality System which is designed to comply with the relevant regulatory requirements.