The evaluation of potential toxicological effects of all biopharmaceuticals
is required by various legislation around the world prior to product registration.
The safety evaluation of these products is performed in mammalian systems for
which extensive background data is required in order to accurately evaluate
any responses observed in the studies. Huntingdon Life Sciences, with over fifty
years experience in this work is ideally placed to assist you with this testing.
We have considerable experience, capacity and a wide variety of skills enabling
us to design and conduct all study types in accordance with the requirements
of the product under test. For example, all the common dosing routes, such as
dermal, inhalation and oral are available as well as some other specialist routes
such as vascular infusion and intrathecal. All areas of regulatory toxicology
can be covered:
- Rodent and non-rodent toxicology
- Acute toxicity – single administration by oral or dermal routes
- Reproductive toxicology
- Carcinogenicity
- Modified local lymph node assay - can be used to assess immunosuppression.
- Distribution and persistence studies (stand alone or combined with toxicity
studies)
- Local tolerance - designed to assess local tissue reactions around the
dose site.
- Skin sensitization test - assessment of the potential to cause delayed
contact hypersensitivity: local lymph node assay
Due to the wide diversity and complexity of biotechnology products, study designs
can be tailored to meet the needs of individual customers. Huntingdon Life Sciences
has the capability to include the following in an individually tailored study.
- Toxicity studies can be performed in rodents, rabbits, dogs, mini-pigs
or primates
- Clinical pathology (with the capability to perform non-routine assays, e.g.
quantification of various cytokines or hormones)
- Immunotoxicology: Flow Cytometry, Natural Killer Cell Assay and Antibody
Plaque-Forming Cell Assay can be incorporated into study designs
- Assessment of the distribution and / or persistence of the test substance
can be incorporated into the study design
- The presence of anti-drug antibodies can be assessed during the study
- Electrocardiography and blood pressure measurement can be incorporated into
the study design
Together with our extensive support departments, we provide the full comprehensive
package of tests required for registration and market authorisation, which ultimately
helps speed your product to market.
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