|
Manufacturers of biologics, such as
blood products, monoclonal antibodies, recombinant proteins, tissue derived
products, and some medical devices, are required to assess the ability
of the manufacturing process to produce a product that is safe for use
in humans. BioReliance has been conducting viral clearance studies for
European, Asian and US clients since 1984. Many biologics such
as plasma derivatives, monoclonal antibodies, recombinant proteins and
medical devices have been licensed around the world using data generated
from viral clearance studies performed by BioReliance. Our clients include
many of the worlds major pharmaceutical and biotechnology companies.
The viral clearance division at BioReliance has
performed more than 2000 clearance studies, including approximately
100 TSE clearance studies and a number of mycoplasma, bacteria and
DNA clearance studies. We were one of the first companies to use
the Western blot assay to study the effectiveness of manufacturing
processes to remove TSEs. This extensive experience helps us to
design the most cost-effective studies for our clients. We have
performed both virus and TSE clearance studies on a wide range of
different products, and different process steps. Our experience
allows us to advise our clients on the most appropriate process
steps to study in order to satisfy the regulators.
- Pioneers in the application of Q-PCR used in conjunction with infectivity-based
assays
- One of the first companies to use the Western blot for TSE clearance
studies
- Real time endpoint testing (process samples tested directly, not frozen)
- Approximately 26 different viruses available
- Virus titres up to 9.0 log10/ml
- Many viruses grown in serum free media without phenol red
- Largest historical clearance study database in industry
- Multiple state-of-the-art viral clearance suites with facilities on
three sites worldwide allows us to commence studies with minimal delay.
- Biohazard category II and III facilities available with 6ft laminar
flow hoods
- Separate virus titration cell banking and assay seed laboratories
- Walk in cold rooms for +4°C process steps available
- Dedicated client offices separate from laboratory areas with computers
available to allow clients to access e-mail.
- A number of ÄKTA chromatography systems available with Unicorn
software version 4.0 and above
- Microprocessor controlled small scale freeze driers
- Free standing fraction collectors, UV monitors peristaltic pumps and
chart recorders recirculating waterbaths, ovens for dry heat treatments
digital chart recorders for temperature monitoring
- Senior personnel are available to meet directly with the authorities,
if required, to review study results and data.
- Our regular dialogue with the FDA, EMEA and other Regulatory Authorities
help ensure the advice we give is up to date and relevant. Expert scientists
provide technical and regulatory support before, during and after completion
of the study.
- Fully validated assays.
- GLP compliant.
- Dedicated QA personnel audit specific steps and procedures during
each study.
|  |
