Q-One Biotech Ltd.

Description

Q-One Biotech provides specialist safety testing services, CGMP contract manufacturing of cell banks, and gene therapy products and process validation services to the biopharmaceutical industry. The company provides the level of quality, technical, and regulatory support that its customers require when outsourcing virological and microbiological studies. All studies are conducted in house so that the company has total control of both the quality and the timing of the studies. Several monoclonal antibodies, recombinant proteins, blood products, and animal-derived products that O-One has tested and validated are now licensed by FDA, EMEA, and in Asia.

Markets

Since its founding in 1990, G-One has worked globally and is well known to the European, U.S. and Japanese regulatory authorities. The company's safety testing and virus validation studies are designed to comply fully with ICH guidelines. O-One employs experts in the design of both scientifically sound and cost-effective strategies for new technologies in areas such as xenotransplantation, tissue engineering, gene therapy, and DNA vaccines.

Services

Technical services offered by O-One Biotech include the following.

Biomanufacturing. O-One Biotech specializes in the CGMP production of master and working cell banks, viral vaccines, and plasmid and viral DNA vectors (including retrovirus, adenovirus, herpesvirus) for gene therapy.

Process validation. The company designs and implements virus, prion, and other contaminant validation studies to satisfy the increasingly stringent guidelines of the regulatory authorities. Service to customers includes advice on the design of the down-scale process and the inclusion of specific contaminant inactivation steps.

Biosafety testing. Q-One is expert in the development and validation of custom assays to detect viruses and other microrganisms. Over 300 study protocols are available and the company's reputation has been built on its extensive range of retroviral assays for all species, its human and monkey viral assays, and the quality of its electron microscopy studies. Its PBRT assay for testing vaccines and its quantitative PCR assays have been widely accepted.

Other services. The company provides the full range of tests required to characterize and establish the genetic stability of expression constructs in both prokaryotic and eukaryotic systems. It offers biodistribution studies for gene therapy and DNA vaccination protocols, and assays for patient monitoring, as well as providing rapid serological and PCR-based assays to screen transgenic animals used in xenotransplantation and to produce therapeutic proteins.

Facilities

Q-One's purpose-built facilities are located at the company's corporate headquarters in Glasgow, Scotland, and Worcester, MA (complete in the Spring 2000). They operate in full compliance with GMP and GLP standards. Whether a company is located in Europe, North America, or Asia, it can be sure that both facilities operate to the same high standards of service and provide consistency in terms of quality systems, study protocols, and technical and regulatory support.

Write in 62

Q-One

Biotech Ltd.

Todd Campus West of Scotland Science Park GLASGOW G20 OXA UK Tel: +44 141 946-9999 Fax: +44 141 946-0000

U.S. facility Q-One Biotech Inc. 5 Biotech 381 Plantation Street Worcester, MA 01605 www.q-one.com marketing@q-one.co.uk

Employees: 160 Founded: 1990