The development of recombinant DNA methodologies and hybridoma
technology, as well as advances in functional genomics and proteomics, has led
to a rapid increase in the number of biopharmaceuticals that are being developed
for human use.
To complement our world-renowned expertise in the testing of new
chemical entities (NCE’s) Huntingdon Life Sciences has considerable experience
in developing biopharmaceuticals. We have been involved in the pre-clinical
safety testing of these products since they were first introduced in the early
1980’s.
Biopharmaceuticals could revolutionise the prevention and treatment
of diseases such as cancer, HIV, inflammatory disease, coronary arterial disease
and genetic diseases that currently are incurable or have inadequate treatments.
The relative infancy and complexity of the science of biopharmaceuticals present
considerable challenges in demonstrating product safety and efficacy.
A scientific and rational approach to biopharmaceutical product
development is crucial. There should be particular focus on the unique characteristics
of the product together with an understanding of the current regulatory environment.
Such an approach can add value to a product and prevent performance of inappropriate
studies or the need to repeat studies later on in the product development process.
Huntingdon Life Sciences has worked with major pharmaceutical
companies and small-medium sized biotechnology companies in developing a diverse
range of biopharmaceutical products leading to their successful registration
in Europe, USA and Japan.
- Blood and tissue products
- Gene and somatic cell therapy products
- Monoclonal antibodies
- Recombinant proteins
- Synthetic polypeptides and nucleotides
- Vaccines
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