Altasciences Preclinical Services
Leveraging decades of experience conducting safety assessment, Altasciences offers a full range of in vivo GLP and non-GLP preclinical evaluation studies in multiple species to thoroughly assess the safety profile of your molecules. Working as an extension of your team, our scientists and technicians help you expedite your research goals, always looking ahead so that you can reach critical decisions faster.
We provide rigorous attention to your needs, data integrity, science, and animal welfare. Our solutions include IND/NDA-enabling toxicology, safety pharmacology, and laboratory services that meet global regulatory requirements, for both small and large molecules. Our preclinical and clinical services work hand in hand to ensure a rapid and smooth transition from safety testing to first-in-human trials.
- 210KSQ.FT. PURPOSE-BUILT FACILITY
- 1400+ safety studies completed to date
- 250+ TEAM MEMBERS
We serve a wide range of clients from multiple sectors, including:
- Nucleic acid therapies
- Stem cell
- Gene therapies
- Genome editing technologies
- Animal health products
PRECLINICAL STUDY TYPES
We offer a full range of IND/BLA/NDA-enabling toxicology and bioanalytical services, providing powerful tools and rigorous solutions to find the answers you’re looking for as you evaluate therapeutic candidates, advance lead compounds toward first-in-human trials, and support ongoing clinical development.
We investigate specific drug characteristics to identify optimal candidates for clinical success.
Our pharmacological testing predicts biological effects of new therapeutic entities, supported by our extensive bioanalysis capabilities.
Our team of scientists is adept at evaluating PK/PD parameters for the characterization of active substances on a test system and understands the importance of selecting the right candidates for development.
A well-designed, streamlined acute toxicity study by Altasciences can help predict likely target organ toxicity and help with dose selection for initial repeat dose toxicity tests. We offer efficient study designs that honor the three Rs of animal welfare (replacement, reduction, refinement), while ensuring that proper scientific rigor is achieved.
Dose Range Finding/Maximum Tolerated Dose
Through a rapid assessment of the toxicological profile of your new therapeutic entity, we will help you establish initial safety — facilitating subsequent regulatory toxicological studies.
REPEATED DOSE TOXICITY
The partner you select to characterize the toxicological profile of your new therapeutic entity can be a difference-maker since it is a key component of your safety assessment program — and we’re ready to exceed your expectations.
Let us help you assess the impact of your therapeutic entity on vital organ systems before first-in-human testing. To support your IND submissions, our experienced team can assist you in identifying and minimizing potential risks earlier, so that you can advance your best molecule.
Sub-Chronic/Chronic, Repeated Dose Toxicity
If your therapeutic entity is intended for repeated or chronic use in patients, we can test it for any adverse effects over extended periods of time up to one year.
We have developed a world-class radiation safety program, performing studies that can take the place of human clinical trials under the FDA’s ‘Animal Rule’.
ROUTES OF ADMINISTRATION
We have expertise with multiple routes of administration, including the ones listed below. If your study needs a route not listed here, please contact us.
- Oral (gavage, diet, capsule)
- Parenteral (intravenous, subcutaneous, intramuscular, intraperitoneal, intrathecal and intra-articular)
OUR PRECLINICAL FACILITY
Altasciences’ preclinical facility provides efficient and standardized workflows to ensure consistency in practices and uniform quality in results — with industry-leading start times and competitive reporting timelines.
- 140 custom-designed animal rooms, including European housing
- Barrier facilities for NHPs, dogs, mini pigs , rodents and rabbits
- AAALAC accredited, USDA registered, OLAW Assurance, BSL-2
- Client-dedicated NHP colonies available upon request
- FDA inspected
- Archive facility and services on site
COMPREHENSIVE FULL-SERVICE OFFERING
Our full support service model complements our preclinical offering to best meet your needs.
- Scientific, Regulatory and Strategic Guidance
- Protocol Development
- Project Management
- Analytical Chemistry
- Bioanalysis (small and large molecules)
- Anatomic Pathology
- Clinical Pathology