Biologics & Gene Therapy 𝘐𝘯 𝘝𝘪𝘷𝘰 Services
In vivo studies using preclinical models are critical throughout biologic development, from early PK/PD studies to GLP-approved safety and efficacy programs. Maximising insight requires expertise in the models, surgical techniques and endpoint assays to provide results you can rely on.
The USFDA recommends preclinical animal studies for assessing various attributes of biologic products, including proof-of-concept (POC) studies, pharmacology and distribution, safety and toxicology and efficacy (Preclinical Assessment of Investigational Cellular and Gene Therapy Products, 2013).
Specific guidance on which animal models are suitable for different studies is often left to the sponsor, but can have a huge impact of the validity and usefulness of results.
Absorption Systems offers the client a wide range of support for in vivo animal studies for research and clinical applications. We offer:
- flexible plans for managing studies, from facility rental to end-to-end design and delivery
- specialist routes-of-entry services, such as ocular or dermal biologics
- custom animal models from a range of rodent and non-rodent species
- diverse studies from POC efficacy to regulator-approved toxicology
The Absorption Systems Difference
Working as an extension of your laboratory, we offer flexibility in the planning of your studies as well as progress reports at each phase. Absorption Systems is AAALAC accredited and USDA registered and maintains an internal Institutional Animal Care and Use Committee (IACUC) in accordance with USDA and HHS regulations and guidelines. We value a close relationship and communication with our clients, you’ll always have a dedicated team who’ll answer your questions within 24 hours and you will know in real-time what is going on with your study.
FREQUENTLY ASKED QUESTIONS
Core Experience and Technology:
In Vivo Studies
- Prepare and approve IACUC protocols in accordance with USDA and HHS regulations and guidelines.
- Development of vaccine immunization schedules, dosing and adjuvant screening
- Dose tolerability and Immunogenicity evaluation
- PK and PD rodent studies
- Extensive experience with Gene therapy applications and AAV testing
- Dermal and metabolism (i.e. DIO) model
- Injection Site Reaction (ISR) studies
- Xenograft tumor models
- Transgenic breeding programs
- Biodistribution studies using Li-Cor Fluorescent Imaging system for tissue section imaging (including full body image).
- Bioanalytical support for dose-ranging and bioavailability studies
- Tissue homogenization, protein and nucleic acids extraction
- Vivarium and Laboratory Space Rental
Our in vivo services include:
- Biodistribution & Shedding
- Small and Large Animal Models
- Regenerative/Stem Cell Testing
- Full Spectrum Ocular Services
- Custom Animal Models
- Immunocompetent & Immunocompromised Models