The pharmacological studies performed on non-human primates (NHP) generate complementary, high quality and valuable data that bridge translational research between small animal models and humans. They are an essential step for the preclinical development of drug candidates.
Based on our extensive experience, Cynbiose’s teams offers support and guidance all along your projects:
- Scientific advice regarding preclinical models and methods
- Technical and scientific support
- Hands-on and flexible study design
- Close and long-term customer relationship
- Preclinical studies undertaken in a highly reliable quality environment (BPL-like)
Preclinical research services
The clinically relevance of NHP models and their predictive power in different types of preclinical studies ensure a successful transition to clinical development.
Pharmacokinetics (PK) and pharmacodynamics (PD) investigations
These exploratory studies produce a complete dataset describing the in vivo behaviour of drug candidates ahead of preclinical regulatory studies.
Cynbiose has unparalleled expertise in Central pharmacokinetics studies and the in vitro and in vivo evaluation of the crossing the blood brain barrier (BBB).
Derisking novel drugs and immunotherapies, particularly in the early stages, further increases the drug candidates’ development success into the clinics.
Early non-GLP toxicology studies
Early assessment of the safety profile of new drugs in a clinically relevant in vivo model will provide preclinical teams with valuable data, in order to derisk discovery programs or help design safety regulatory studies.
Our experienced and skilled teams will provide you with time and cost-effective non-GLP toxicology studies, such as:
- Toxicokinetics and tolerability studies: single-dose or dose-escalation studies
- Dose range finding studies (DRF / MTD)
- Safety pharmacology to determine the MABEL and identify potentially adverse functional effects (NOEL, NOAEL).
One of Cynbiose’s main assets is the ability to tackle complex, unorthodox experimental designs: we routinely combine PK and safety elements in order to provides sponsors with custom protocols.
Efficacy studies with pharmacological models (POC)
We provide proprietary and predictive physiopathological models providing decisive evidence of the efficacy of drug candidates. Discover our in vivo models for Proof of Concept studies or contacts us for the development of customized efficacy models.
Types of products
- Small molecules (NCEs)
- Viral vectors, such as adeno-associated viruses (AAV), adenoviruses, lentiviruses, …
- Advanced therapy medicinal products (ATMPs), such as cell therapies, CAR-T, tissue engineered medicines, ASO…
- Gene therapy medicinal products (GTMPs)
- Medical devices
- Oral (nasogastric, oral)
- Parenteral routes: classical routes (IV, SC, IM, ID, IP), intrathecal, intracerebral, intravitreal, intravaginal, intranasal, intratracheal, intra-articular (knee)
- Inhalation: aerosolization, nebulization
- Topical: dermal
Our veterinary team masters a wide range of surgical skills based on a decade-long practical experience, and performs high quality surgery to fit the sponsors’ requirements.
Depending on the study’s objectives, our highly skilled technicians can provide various sampling of fluids, tissues and organs. These sampling methods include the collection of blood, saliva, tears, urine, feces, CSF, organ biopsies, etc.
Different options are available for further bioanalysis.
Cutting-edge proprietary exploration platforms
- KineC3© dedicated to the study of the crossing of the blood-brain barrier (BBB) for drug candidates targeting the central nervous system.
- Kine IA© : thanks to in-house techniques for vascular catheterization of the portal vein, we are able to conduct pharmacokinetics studies to examine the «first pass effect » (also known as first-pass metabolism) of active substances administered orally.
Clinical follow-up and Bioanalysis
We have developed specific expertise and skills for the clinical monitoring of our animals. Specific proprietary evaluation grids have been developed and are continuously improved upon for the assessment of different clinical aspects (neurological signs and behavior, locomotion, etc…).
Various types of bioanalysis can be performed, either internally or thanks to our local and european network of preferred partners:
- Clinical pathology, including on infectious or GMO BSL1-3 samples
- CBC with differential WBC
- Blood pressure, ECG
- Implanted body temperature logging
- Bleeding time tests
- Circulating biomarkers (ELISA, LUMINEX)
- Immunophenotyping (FACS)
- Histopathology / Immunohistochemistry
- Specific analyses: Viremia, bacteremia, Ab, Nab, ADA
- Pharmacokinetics (e.g. LC/MS/MS)
In vivo preclinical imaging
Thanks to its anatomy similar to human regarding critical aspects (brain, joints, lungs…), the non-human primate can be involved in clinically relevant imaging protocols, using the same devices and methods than those used in human patients. Cynbiose has established long-lasting relationships with public and private partners to offer multimodal state-of-the-art imaging methods, such as :
- Echocardiography, Doppler
- CT scanner, µCT scanner