Horsham, Pennsylvania

Explore Our Horsham, Pennsylvania Site

Development and Reproductive Toxicology (DART)

Charles River offers overall developmental and reproductive toxicology (DART) program planning and individual study design to conduct safety assessments for your products according to internationally recognized guidelines, including ICH and OECD.

The Safety Assessment site in Horsham, PA, has been performing developmental and reproductive toxicology studies for over 40 years and juvenile toxicology studies for over 30 years. The long-standing reputation of this site as a leader in reproductive toxicology has resulted in a broad range of experience with pharmaceuticals, including small and large molecules, chemicals and agrochemicals, gene therapies, and cellular therapeutics. Our scientists at Horsham can conduct studies to assess the potential effects of a test article on the full spectrum of reproduction as well as perform a range of specialized functional evaluations, including neurobehavioral testing and immunologic assays. 

Juvenile Toxicology

We offer juvenile toxicology studies to evaluate pharmaceutical and biologic drugs indicated for pediatric use. We have decades of experience planning, designing, and performing these studies, ensuring they assess specific developmental milestones from birth to adulthood.

Phototoxicology

The evaluation of a product’s phototoxic potential is an important part of its safety assessment. Utilizing different light sources, our scientists at Horsham can perform a broad range of preclinical in vitro and in vivo phototoxicology studies in addition to the ability to customize these and other study designs to the Sponsor’s specific requirements.

Cell and Gene Therapy

The journey to market for a cellular therapeutic is challenging due to the unique nature of each individual program. Our extensive expertise in handling immunodeficient mice and rats, specialized dosing expertise, skill in maternal and litter handling, scientific expertise, postmortem tissue handling, on site PCR analysis, along with our collaboration with sites performing the bioanalytical, histopathology and immunohistochemistry endpoints for these studies allows for the successful design, execution and interpretation of these always unique studies.

Horsham has extensive experience in gene therapy studies using several vectors and with expertise in maternal/litter handling, neonatal dosing expertise, quality tissue collection for PCR and on site PCR analysis, the site has all the tools necessary to perform these studies. The site can perform work with level 1 biological risk category materials and with limitation level 2 biological risk category materials.

Formulations and Analytical Chemistry Laboratory

Horsham has a separate and fully equipped facility offering formulation and analytical chemistry services. The Formulation team works closely with the Study Director and Client to ensure successful preparation of dosing solutions to support the various study designs. The team has extensive experience in handling a variety of Drug modalities and preparation techniques and is skilled in supporting the unique features of DART, juvenile, cell and gene therapy study designs.

The Analytical Chemistry team provides support services meeting the Dose- Formulations-Analysis (DFA) criteria for GLP studies. The team can provide analytical services using Ultra-Violet and Visible Light Spectrophotometer (UV-Vis), High-Performance Liquid Chromatography (HPLC), and Ultra-Performance Liquid Chromatography (UPLC) techniques. The team has extensive experience in developing and validating Analytical assays to support Dose confirmation for GLP and Non-GLP studies.

In Vitro Services

Horsham's In Vitro Services team has extensive experience in providing GLP compliant in vitro phototoxicity study services, including evaluating UV-VIS Absorption Spectra of chemical moieties and routinely performing the OECD 432 In Vitro 3T3 Neutral Red Phototoxicity Test. The In Vitro team also has experience in developing and validating large molecule biomarker methods to support GLP compliant biomarker analyses. The team's cell culture expertise supports cell therapy study designs. They work with the Study Director and Client to ensure successful study planning and formulation procedures for various cellular therapy products to support GLP cellular therapy toxicology studies.

The team's cell culture expertise supports the formulation of various cell therapy products for toxicology studies. They also assist in preparation of study specific cell preparation procedures of various cell products.

Molecular Biology

Horsham’s Molecular Biology team is skilled in developing and validating quantitative real time PCR assays to support the GLP analysis of various tissues and matrices for gene therapy studies. The team has experience with a variety of vectors and can support primer design for different projects. The team has also validated an off the shelf assay for a human teleromase reverse transcriptase gene to support biodistribution studies of cellular therapy products.

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