Preclinical Translational Research Centre

Prof. Yulia Vakhitova, DSc in Biology
RAS Corresponding Member
Director of Preclinical Translational Research Centre

The specialists at the Preclinical Translational Research Centre are responsible for the following:

• Full cycle of high-tech basic, applied and preclinical research
• Development and validation of analytical methods and various disease experimental models, from in silico to in vivo
• Development of new methods of prevention, diagnostics and treatment

The Preclinical Translational Research Centre comprises:

• Large animal vivarium with an operating theatre
• SPF vivarium with an operating theatre
• Aquatics area
• Laboratory rodent nursery
• Laboratory for embryo transfer, transgenesis and cryopreservation
• Analytical laboratories for a wide range of research at the highest level of technology and methodology

Through collaborative efforts with prominent pharmaceutical companies, we have built a strong reputation for delivering excellence in the organization and execution of a wide range of trials, encompassing diverse stages of the life cycle of medicines and medical devices. Our expertise extends from the early stages of development to the launch of the drug into circulation.

The Preclinical Translational Research Centre operates strictly in accordance with the principles of Good Laboratory Practice (GLP).

We conduct preclinical studies of biological, biosimilar and synthesized drugs, medical devices, medical technologies and biomedical cell products. Our services include developing the terms of reference and the preclinical study plan, transferring a complete package of reporting documentation and accompanying documents to the customer, necessary for the preparation of a registration dossier.

Our clients:

• Pharmaceutical companies
• Biotechnology companies
• Public and private universities
• Public and private research institutes
• Contract Research Centres
• Testing centres

Our advantages:

• 100% compliance with deadlines
• Turnkey delivery
• State of the art equipment
• Risk-oriented quality management system
• Highly qualified personnel
• Transparent pricing

Structure

• Directorate
• Preclinical Research Support Group
• Quality Assurance Unit
• Testing Centre:
  — Veterinary Service
  — Pharmaceutical Department
  — Sterilization Department
  — Chemical Analysis Unit
  — Cell and Genetic Technology Unit
  — Pathomorphology and Histology Unit

The work is carried out in close cooperation with the client and the departments of Almazov Centre responsible for document management and administration.

Our principles:

• Adherence to AAALAC International requirements
• Adherence to Standard Operating Procedures
• Compliance with EU principles of Good Laboratory Practice (GLP OECD)
• Compliance with Russian regulatory requirements
• Adherence to ISO 9001 principles
• Engagement with certified suppliers only
• Video recording of technological processes
• Process redundancy
• Technological zoning
• External monitoring of animal health status (Sentinel Animal Program)

Preclinical studies
Recombinant protein production
Polyclonal antibody production
Preclinical studies of radiopharmaceuticals
Breeding of laboratory animals
Preclinical studies of medical devices and testing of surgical techniques
Open lab and methodological guidance
Biobank and master bank services
Large animal studies
Consulting
Laboratory animals
Equipment