Q-One Biotech provides specialist safety testing
and process validation services and contract
manufacturing to the biopharmaceutical industry.
Our services include GLP accredited safety testing
of biopharmaceuticals, human blood products,
vaccines, transgenics and gene therapy products.
Q-One Biotech has devised over 300 study protocols
to test cell lines, biological material and final
products to fulfil regulatory requirements. We can
also validate your processes for
removal/inactivation of viral, DNA, mycoplasma and
scrapie/BSE contaminants. The company offers a GMP
production unit to serve the gene therapy and
vaccine industries in the manufacture of viral
vectors, cell banks, plasmid DNA and vaccines.
Q-One's purpose built facilities are located in
Glasgow, Scotland, UK and Worcester, MA, USA and
operate
in full compliance with GMP and GLP standards.
Both our facilities operate to the same high
standards of service and provide consistency in
terms of quality systems, study protocols and
technical and regulatory support. In early or late
stage biological product development, Q-One is
here to provide the support you need.
We have been successful in forming lasting
partnerships with many of the major international
biopharmaceutical and biotechnology companies, and
have tested and validated a number of products
which are now licensed by the EMEA, FDA and
Japanese Ministry of Health and Welfare.
This quality service and scientific excellence is
provided in the testing and validation of:
Monoclonal antibodies
Human blood products
Recombinant DNA products
Gene therapy products
Human vaccines Veterinary vaccines
Transgenic animal products
Xenotransplants
Medical devices
Q-One provides comprehensive services for the
complete characterisation of cell lines and the
validation of the manufacturing process, using the
following techniques:
In vitro co-cultivation and infectivity assays
In vivo assays
Polymerase chain reaction, DNA hybridisation,
ELISA, lmmunofluorescence
Isoenzyme, DNA fingerprinting and Karyology
Electron Microscopy
Mycoplasma and Sterility assays
Genetic Stability - DNA sequencing, mRNA analysis,
copy number, FISH
Tissue cross reactivity studies
and offer a GMP production unit to serve the Gene
Therapy and Vaccine industries in the manufacture
of:
Viral Vectors Plasmid DNA
Cell Banks Human and Veterinary Vaccines
Our services enable clients to submit to
regulatory authorities such as the US Food and
Drug Administration (FDA), the European Medicines
Evaluation Agency (EMEA) and the Japanese Ministry
of Health and Welfare confident in the knowledge
that their product licence application has
addressed all the relevant biosafety issues.
The reliability of Q-One's service is a result of
rigid adherence to quality assurance and Good
Laboratory Practice (GLP) which is critical for
the acceptance of data by regulatory authorities.
We are fully accredited for GLP by the UK
Department of Health GLP Compliance Unit and for
cGMP by the UK Medicines Control Agency.
