Q-One Biotech (Acquired By And Now Part Of BioReliance)
Press releases archived for reference only.
West of Scotland Science Park
North America Location:
381 Plantation Street
Worcester, Massachusetts 01605-2323 U.S.A.
Phone: 508-791-8000 Fax: 508-791-8008
Q-One Biotech is a world-renowned company providing specialist safety testing services, cGMP contract manufacturing of cell banks and gene therapy products and virus validation services to the biopharmaceutical industry. We are committed to providing the level of quality, technical and regulatory support that our customers require when outsourcing virological and microbiological studies. All our studies are conducted in house so that we have total control of both the quality and the timing of the studies.
Q-One Biotech was founded in 1990 with just 5 employees, and has expanded worldwide to more than 260 in 2003. Whether your company is located in Europe, USA or Asia our two facilities provide consistency in terms of quality systems, study protocols and technical and regulatory support.
We have been successful in forming lasting partnerships with many of the major biopharmaceutical and biotechnology companies around the world, and have tested and validated a number of products that are now licensed by the FDA and EMEA. Our services enable clients to submit applications to the regulatory authorities in the USA, Europe and Japan confident in the knowledge that their product license application has addressed all of the relevant biosafety issues.
Biosafety Testing: Development and validation of custom assays to detect viruses and other microorganisms (over 500 study protocols are available). Our PBRT assay for testing vaccines has a worldwide reputation and we are experts in the development of quantitative PCR assays.
Virus Validation: Design and implementation of virus, prions and other contaminant validation studies to satisfy the guidelines of the Regulatory Authorities. Advice on the design of the downscale process and the inclusion of specific contaminant inactivation steps.
BioManufacturing: cGMP production of master and working cell banks, viral vaccines and viral vectors (including retrovirus, adenovirus, herpesvirus) for gene therapy.
Regulatory Services: Q-One Biotech can provide a full range of Regulatory Affairs activities ranging from an advice and consultancy service through to expert reports, dossier preparation and submission. Specific reports can be prepared depending on our client's unique requirements. These can be provided as stand-alone documents or as part of the entire submission. Q-One Biotech can also co-ordinate, maintain and update submissions on our clients behalf.
Other Services: Characterisation and establishment of genetic stability of expression constructs in both prokaryotic and eukaryotic systems; biodistribution studies for gene therapy and DNA vaccination protocols; assays for patient monitoring; rapid serological and PCR-based assays to screen transgenic animals used to produce therapeutic proteins and in xenotransplantation.
Last Updated: 10-06-03