Biobest hold a GMP Test Site (Biologicals) certificate from the MHRA. This means that we are authorised to perform biological QC testing in accordance with Art. 111(1) of directive 2001/83/EC (or Article 80(1) of Directive 2001/82/EC) transposed in the following national legislation: For human medicines 'The Medicines Act 1968 as amended'; for veterinary medicines 'The current Veterinary Medicines Regulations'; for investigational medicinal products 'The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)'. A copy of our current GMP certificate can be found here.
Biobest operates to the international standard of Good Laboratory Practice (Good Laboratory Practice Regulations SI 1999:3106 as amended by SI 2004:994) as inspected by the UK Department of Health. All results are internally quality controlled before reporting.
Biobest is accredited by UKAS to ISO/IEC 17025:2005 for diagnostic tests where relevant. Accreditation not only assures the quality of the tests performed by Biobest, it also covers customer service, procedure validation, supplier performance, and organisation management.
Biobest are a VMD authorised Equine Stem Cell Centre. This authorisation enables us to prepare autologous mesenchymal stem cells for use in the treatment of tendon and ligament injuries in horses. A copy of our ESCC authorisation can be found here.
Rabies Serology Testing
All rabies testing is carried out in a dedicated category 3+ laboratory on our site at the Pentlands Science Park. Biobest's quality of results are ensured through participation in the annual rabies serology proficiency tests organised by the world reference laboratory.