Characterisation of a biopharmaceutical product, determination of physico-chemical
properties, biological activity, immunochemical properties, purity and impurities
by appropriate techniques is essential for identifying the key characteristics
of the product that should be considered when setting specifications for the
product. These should be defined prior to conducting early clinical studies
since they are essential for demonstrating product and process consistency and
quality as well as demonstrating comparability, i.e. that a product used in
early studies is the same as that intended for marketing.
Huntingdon Life Sciences offers a comprehensive analytical service for characterisation
of biopharmaceuticals as recommended in the ICH guideline:
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- Biological activity
- Concentration
- Biological activity
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Our scientists are able to characterise reference material, bulk or formulated
material and a Qualified Person is available for GMP batch release of your product
for clinic or market.
- Amino Acid Analysis
- Biological Potency Assay
- Carbohydrate Analysis
- DNA Content
- ELISA
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- Endotoxin determination
- Host Cell Protein
- HPLC
- IEF
- Mass Spectrometry
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- N- and C-Terminal Sequencing
- Peptide mapping
- SDS PAGE/Western blotting
- Sterility
- Water Content
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We are able to carry out development of the new method or the optimisation
of existing methods and method validation to regulatory standards (ICH and FDA)
ensuring that these methods are successfully transferred to the Contract Manufacturing
Organisation (CMO). Complementing our biopharmaceutical analysis capacity are
our storage facilities. We can offer walk-in controlled-environment rooms that
meet current ICH requirements for biopharmaceutical storage. In addition, long-term
and short-term stability analysis can be conducted in accordance with ICH Q5C,
other customer-specific storage requirements and photostability testing (ICH
Q1B).
We operate in compliance with current GMP regulations, as they relate to quality
control laboratories. The pharmaceutical analysis operations are subject to
regular GMP compliance inspections by the US (FDA) and EU (UK Medicines and
Healthcare products Regulatory Agency - MHRA) authorities and are approved for
nomination as a Contract Acceptor on product licences.
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