Center of Preclinical and Translational Studies

Presentation of the Center of Preclinical and Translational Studies

Transcript

1. Almazov National Medical Research Center CENTER FOR PRECLINICAL AND TRANSLATIONAL STUDIES (CPTS)
2. Since 2018, the CPTS has been providing a wide range of scientific and preclinical studies at state- of-the-art level in compliance with international standards. The uniqueness of our center reveals the fact that we are both a nursery for key laboratory animal species and a site with equipped laboratory facilities for a wide range of research.
3. Our advantages: Strict adherence to research deadlines 1 2 3 Extensive technological capabilities Transparent price formation 4 Strict adherence to industry standards
4. Our principles: - Compliance with AAALAC International requirements - Compliance with standard operating procedures (SOPs) - Compliance with EEA Good Laboratory Practice (GLP OECD) - Compliance with Russian regulatory requirements - Adhere to ISO 9001 guidelines - Working only with certified suppliers - Redundancy of technological processes- Technological zoning- External monitoring of animal health status (Sentinel programme)
5. State-of-the-art facilities and highly qualified staff are the most important resources of our centre We carry out high-tech basic, applied and pre-clinical full-cycle research, develop new ways of preventing, diagnosing and treating diseases, evolve and validate experimental models of various diseases from in silico to in vivo.
6. We carry out research and quality control outputs: - Original, hybrid, combination and biosimilar medicines (including therapeutic antibodies) - Vaccines - Medical devices - Medical technology - High Technology Medicines - Preparations based on human somatic cells
7. In our storage we have a large number of validated models of pathological processes and diseases for pharmacological drug activity studies
8. List of ongoing pre-clinical studies - General toxic properties - Metabolism - Specific toxicity - Pharmacodynamics - Comparability of biosimilar drugs - Cross reactivity of therapeutic antibodies - Stability - Biological and immunochemical activity in vitro - Quality Control in Site Changing - Quality Control Biologics - Final quality control etc.
9. Our centre produces recombinant proteins for research purposes growth factors, complement system proteins, receptors, enzymes, etc.
10. We offer preclinical testing services of radiopharmaceuticals The service is carried out in strict compliance with the requirements of the Federal Act on “Radiation safety of the population"
11. Turnkey pre-clinical studies 01 02 03 04 05 Terms of Reference development and approval Creating a research plan Conducting the experimental part Formation of a list of documents for the registration dossier Performing an animal study
12. We breed high quality laboratory animals and sell them - We keep and breed laboratory animals (mice, rats) in individually ventilated cages behind the barrier line - We keep medium and large laboratory animals (mini pigs) - Engage in the generation of transgenic and knockout mice - Conduct redistribution activities. - Ensure the health of laboratory animals kept - Protect personnel from allergens
13. - The nursery premises comply with the sanitary and veterinary regulations - The air supplied to the animal housing is cleaned in two stages and complies with ISO class 7 cleanliness - The facility's bio-safety level complies with ABSL-1 (minimum level of bio-hazard) - According to the Russian Federation classification, the facility is allowed to handle microorganisms of pathogenicity group IV Work process in the vivarium is carried out in accordance with GLP standards and in full compliance with technological procedures
14. The area of the kennel allows for the simultaneous keeping of 13 PIGS 250SPURGE FROGS 12 000 RATS 25 000 MICE 34 000 DANIO RERIO FISHES
15. To perform surgical modifications on laboratory animals, our centre has a 50 m2 operating theatre equipped with two operating tables with a full range of anaesthetic, respiratory and resuscitation equipment There is an operating theatre in the large animal holding area. It is equipped with all the necessary equipment, in particular the Da Vinci robotic surgery system
16. We have four lines of transgenic fish Danio rerio - Sox 10 CreERT 2 ubi Zebrabow S - Krox 20 GAL 4 /UAS Cre DsRed - HB 9 GFP - Casper lines
17. The Danio rerio genome contains homologues of 80% of the genes responsible for inherited monogenic diseases in humans. The fish are therefore successfully used in research on human diseases, including haematological disorders, tumours, heart, muscle, kidney, central nervous system disorders and eye diseases.
18. Studies with Danio rerio: - Screening of biological activity, toxicity and mutagenicity of chemical compounds - Developmental, embryo and organogenesis biology studies - Genetic modification using morpholine oligonucleotides - Studying the mechanisms of angiogenesis using molecular imaging techniques
19. We are open to cooperation with biotechnology and pharmaceutical companies as well as medical universities for research projects of a basic and applied nature. We are also ready to offer our site for you to conduct independent research. At your service: • state-of-the-art Russian and foreign equipment • Metodological advice from our specialists • wide range of animal species for research Open Lab and the methodological assistance
20. We offer biobanking and master bank services - Collection of blood samples, NK (DNA, RNA), proteins, tissue, cell cultures, etc. - Aliquoting of biosamples - Storage of biosamples in cryochambers (-80°C and -196°C) We work with databases and biosample collections: - Provide necessary collections of biosamples - Store medical and laboratory information about biosamples - Exchange biological samples between biobanks and medical institutions
21. Contacts: 43 Dolgoozernaya str., St. Petersburg, Russia www.almazovcentre.ru Cooperation: Anastasia Kirichenko, D.Sc. (Biology) Director of Center of Preclinical and Translational Studies Phone: +7 (931) 533-59-39 Mail: kirichenko_as@almazovcentre.ru