BioReliance’s mammalian toxicology services include:
Functional Observation Battery (FOB)
The Functional Observation Battery (FOB) is a series of tests and evaluations to detect gross function deficits resulting from exposure to chemicals. This battery is run in conjunction with neuropathologic evaluation and/or general toxicity testing to assess potential neurotoxicity of chemicals.
To support in vivo studies performed at BioReliance or for outsourced efforts, BioReliance performs full Bioanalysis with state-of-the-art Mass Spectrometry to prepare Toxicokinetics reports.
Transgenic Carcinogenicity Studies
Advances in our understanding of the mechanisms of carcinogenesis combined with the ability to create transgenic animals have given toxicologists new tools with which to test materials for potential carcinogenic activity.
The Food and Drug Administration (FDA) announced in 1997 that it adhered to the International Conference on Harmonization (ICH) S1B Guideline "Testing for Carcinogenicity of Pharmaceuticals." Click here for more info.
This was a dramatic milestone for institutionalizing the use of short-term transgenic mouse models for carcinogenicity testing. Much of the early validation work that led to the FDA acceptance of the ICH guideline was carried out at BioReliance under a National Toxicology Program (NTP) contract, giving BioReliance a unique advantage in this new area of toxicology.
BioReliance also participated in the research collaboration organized by the International Life Sciences Institute (ILSI). These new alternative animal models are now accepted globally by regulatory agencies as a replacement for one of the two long-term lifetime studies that were previously required, and give results in less than one year.
Short term transgenic studies bring you an accelerated time-to-market and the security and confidence you need now with the approval of the regulatory authorities.
ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), Guidelines S1B "Testing for Carcinogenicity in Pharmaceuticals." See website for more information: http://www.ich.org/
BioReliance offers the three transgenic models accepted globally by regulatory agencies as an alternative to traditional studies.
- Tg.rasH2 Non-genotoxic drugs or genotoxic non-dermal drugs
- P53 +/- Genotoxic drugs
- Tg.AC Dermal drugs
Traditional Toxicology Studies
Single-dose, 14-day or 28-day repeated-dose and 90-day subchronic studies are currently performed at BioReliance.
Analytical Chemistry Services
Method Validation using HPLC or GC methodology to include:
- Formulation verification
- Stability, homogeneity and purity determinations
- Sample Retention/Storage Services
- Repeated-Dose Studies
BioReliance offers a fully validated, state-of-the-art GLP analytical service using Liquid Chromatography–Mass Spectrometry (LC/MS). This powerful technology provides quantitative analysis of chemicals within a given sample, with high sensitivity and selectivity.
Gene Therapy Toxicology Studies
BioReliance provides preclinical safety studies for nucleic acid–based therapeutics, including gene therapies, viral oncolytics, DNA vaccines and other gene-based products. Studies offered include acute toxicity, repeat-dose safety tests and biodistribution studies.
Custom Vaccine Toxicology Studies
BioReliance provides vaccine toxicity studies in rats, mice or rabbits. Animal models are used to determine the toxicity of a vaccine by evaluating clinical signs, immunogenic response and clinical pathology.
Specialty Toxicology Studies
BioReliance has experience in the successful management and performance of multidisciplinary biomedical and toxicological research projects that draw scientific expertise from a variety of disciplines. Specialty studies include enzyme induction studies, tumor initiation and promotion.
In June 2007 a new European Union (EU) regulation on the management of chemicals came into force. This regulation is known as REACH (Registration, Evaluation and Authorisation of Chemicals). See website for more information: http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
REACH was enacted to ensure that all chemicals on the market in the EU do not adversely affect human health or the environment. BioReliance offers an extensive line of services for the toxicology testing required by REACH.
Biodistribution studies are necessary to provide pre-clinical safety evaluation of novel gene therapy technologies and to address regulatory concerns. They are designed to investigate the integration or expression of the vector construct in the germ line, the persistence of the vector in the target tissues and dissemination to non-target tissues. Quantitative PCR (Q-PCR) is the method of choice for the detection and quantification of specified gene sequences in biodistribution studies. BioReliance is a world leader in the development and application of Q-PCR methods.
By combining the capabilities of our state-of-the-art animal facility and experienced staff, we can undertake a complete biodistribution study. We will ensure that critical assay steps such as nucleic acid extraction from tissues are conducted under the most stringent conditions so that samples are in optimal condition for highly sensitive molecular assays. At BioReliance, these studies are performed in GLP compliant facilities and meet full regulatory requirements.