| Analytical Services
is a broad term and is used here to describe our operations in the
fields of Analytical Chemistry, Bioanalytical Analysis and Immunoassay.
Our Analytical Chemistry group was set up in
1999 and is housed in well-equipped laboratories with up-to-date
analytical instrumentation, including extensive chromatographic
and electrophoretic equipment. The group, which is based on two
sites in the UK and the US, offers comprehensive services for all
your lot release, stability testing, assay development and routine
testing needs.
Our scientists are experienced in transferring
client validated assays to BioReliance laboratories quickly and
efficiently, using a custom prepared transfer protocol. We have
transferred a wide range of assays which are used for the lot release
of our clients’ material into the market and include peptide
mapping, carbohydrate analysis, deamidation analysis, HPLC (SEC,
IEX, RPC), SDS PAGE, IEF and UV spectroscopy.
BioReliance can also aid in the assessment of
the short and long term stability of your materials in development,
under either forced degradation or long-term storage conditions.
We can provide sample storage and associated assays under ICH recommended
conditions: -70°C, -20°C, 4°C, 25°C/60%RH (relative
humidity), 30°C/60%RH, 40°C/75%RH and photostability cabinets.
BioReliance Analytical Services employ a wide
range of methods and techniques to ensure that your product is well
characterized. Our services include:
The Bioanalytical and Immunoassay departments
are located in both the US and UK. The departments offer a comprehensive
service in analysis of test samples for stability and potency using
a variety of biological and immunoassay methods.
Custom assays may be developed using our wide experience in the
application of biological potency assays and immunoassays. We have
performed many successful transfers of existing assays in-house
from clients laboratories in order to meet specific testing requirements.
Services offered include assay development and validation, stability
testing, bio-potency testing and analysis of purified drug &
final drug products for contaminating host cell proteins or contaminating
reagents.
Other services include:
- Purposeful Degradation
- Method Development
- Comparability Testing
- Method Transfer
You can order: BioReliance's Guide to Analytical Testing of
Biopharmaceuticals, please email info@bioreliance.com
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