- Preclinical testing on animals under the strict OECD (OECD – Organisation for Economic Co-operation and Development) GLP conditions (GLP – Good Laboratory Practice) is a key and indispensable element in the development of novel pharmaceuticals. Ethical codex guidelines for the use of experimental animals are strictly followed (link). Successful completion of preclinical studies is essential prerequisite for starting Clinical trials on humans. Due to the existing vast knowledge base, as well as functional facilities, the preclinical studies on promising therapeutic agents can be performed very effectively within Czech Academy of Science (CAS). Promising potential drugs will be generated within CAS. Commercially oriented entities can also participate. Range of our services within CPT is growing continuously very often based on your unique projects and requirements. In addition to our core activities, which comprises toxicity testing, pharmacokinetic and toxicokinetic testing, hematology, clinical chemistry and histopathology, we can provide additional specialized studies in the area of cardiology, immunology, neurophysiology, pharmacological studies on xenografts, including PDX and others. We also offer various methods for imaging in vivo, from microscopy or roentgen, echography to micro PET/CT for radionuclides.
Several animal husbandry facilities within CAS are available, allowing to conduct a wide scope of preclinical testing using different animal models comprising e.g. mice, rats and minipigs. We are experienced with biocompatibility studies, for instance implants. We prepare highly optimized systems for xenotransplantations (e.g. heart valves). We are experienced in organic synthesis and can on the request help with preparation of chemical substances with therapeutic potential. Therefore, we can realize complete preclinical studies with these substances as a one stop shop solutions. We are proud to be able to offer you our professional services for reasonable cost (value for money), fast track approach, flexibility, fair prices, interesting delivery time, studies under GLP regulations, including studies under GMO regulations. Some of our facilities are designed as SPF.
- Toxicity studies, including toxicokinetic studies of promising chemical or biological agents on model animals – rodents and non-rodents (test systems: mouse, nude mouse, rat, guinea pig, rabbit, minipig) in compliance with ICH (International Council for Harmonisation) and OECD (Organisation for Economic Co-operation and Development) guidelines (e.g. skin irritation test, limit test, MTD, DRF studies, 28 days or longer TK GLP studies).
- Bioanalytical, hematological and biochemical testing of samples taken from animals during toxicity studies (determination of active substance in plasma or other biological matrices. We offer common hematology parameters like RBC, HCT, HGB, WBC, MCH, MCHC, MVC, PLT, or others based on the needs of sponsor, biochemical parameters like ALT, AST, CREA, UREA, TBIL, CHOL, GLU, TP, ALB, ALP, GMT, or others based on the needs of sponsor)
- Development and validation of bioanalytical methods for various test systems and biological matrices.
- Determination of metabolites in tissues and biological matrices (blood, plasma, urine)
- Histopathological evaluation of tissues from animals used in toxicity studies
- Pharmacological studies on xenografts (nude mice) with various cancerous cell lines, including Patient Derived Xenografts (PDX); patient derived xenografts is the area of interest, which is now being established, studies to determine therapeutic window of promising therapeutic agents.
- Cardiology diagnostic tests on animal models – electrocardiogram (ECG), blood pressure measurement, cardiac imaging (Echo)
- Synthesis, characterization and certification of chemical substances with therapeutic potential, development of formulations for drug application (well-equipped technology lab, top chemists, complicated custom synthesis – non GMP)
We are always trying to search for optimum specific service based on unique needs of our customers, utilizing mix of our best competencies within CAS.
We have long term experience with toxicity studies for our partners within CAS and for commercial parties.
We have performed considerable amount of acute oral toxicity studies, MTD and DRF studies on rodents
Institute of Organic Chemistry and Biochemistry of the CAS
University of California
FNUSA – ICRC