Rodents. Simulation of physiological effect of drug exposure to human body is the obligatory stage of the life cycle of any drug product. The use of laboratory SPF animals (pathogen-free and, correspondingly, having intact immune system) is the most reliable way for laboratory tests. We use certified lines of laboratory animals meeting international AAALAC requirements for studies.

Rabbits. In accordance with the regulatory requirements, preclinical drug studies should be carried out on several types of biological models - rodents (mice, rats, hamsters) and non-rodents (rabbits, mini-pigs, etc.). Physiological particularities of the rabbit immune system, and namely, the highest reactivity, the lack of opportunities for studies of capsulated forms in rabbits, and the requirements to local irritance studies make the rabbits a convenient laboratory model, and the use of SPF makes the study scientifically reliable.

Primates. Transfer of fundamental studies on immunobiological, innovative and biosimilar biotechnological products on human population makes it necessary to use relevant biomodels, in particular, primates. The GLP study program developed together with SNAS specialists for studies on non-human primates guarantees the proper quality of studies and includes the quality control and assurance system for studies, as well considers administrative and ethical particularities.

Certified cell lines. Drug efficacy studies should include tests of cell lines which are kept in specialized cell banks. The documented certificates of proper origin – Certificates of cell lines, conditions of their storage and cultivation are the obligatory part of the Preclinical study report and Drug registration dossier. The use of certified lines allows to predict with high reliability pharmacological effects of a drug In Vivo.

Validated systems including the new ones. Immunotoxicity studies of innovative and biosimilar biotechnological and immunobiological drugs should include immunotoxicity testing – the assessment of immune system reactivity on a study product. The detailed information on physical and chemical properties of a study product is necessary for creation of ELISA system based on which an antigen should be first determined, and then specific antibodies should be derived in corresponding biological models. The creation of validated AG-AT systems is a reliable instrument for assessment of immunotoxicity in preclinical drug studies.

Antibody and antigen conjugation. We offer the whole range of services on production of antibodies beginning from animal immunization, production of ascites fluid (scaled manufacture), selection of anti-sera (scaled manufactured) to selection of monoclones and affine purification of antibodies. Moreover, the detailed antibody characterization: all types of ELISA testing, western-blotting, immunocytochemistry, immunohistochemistry and other methods. Production capacities of the animal facilities allow to produce more than 15-20 gram of antibodies or their conjugates a month.

Immunization of SPF models. Protocols of animal immunization, methods and technologies for investigation of immunogenic vaccines, protein and synthetic products require to use a cascade of certified biological models which is not possible without participation of highly qualified specialists. The presence of the professional team having more than twenty-year working experience in engineering immunology and unique GLP animal facilities in which more than 3000 mice, 500 rats, 100 rabbits with SPF-status may be concurrently maintained which allows to carry out simultaneous immunization of several carrier models and to reduce terms for production of the final biological product.

Additional antibody-related activities: preparation of protein conjugates with the carrier protein (for animal immunization), isolation of antigens from various biological samples, preparation of Fab antibody fragments, preparation of antibody conjugates with various labels (enzymatic or fluorescent labels, biotinylation, etc), preparation of affine carriers (sorbents, long-term maintenance of immunized animals.

Early Phase Clinical center. The Clinical Site of the Pushchino Scientific Center has the separate unit equipped for 45 beds and personnel of 50 ICH GCP certified physicians and medical employees, own base of healthy volunteers. The Clinical Site is equipped with modern highly technological laboratory equipment for biosample handling and storage, the separate resuscitation room is allocated. The site was accredited for the early phase clinical studies and bioequivalence study, Certificate №1284 dated 08.07.2016

Site Management Organization. Additional quality assurance of clinical studies in the center owing to:

• participation in development, implementation and control of the site quality management system by the SMO coordinator;
• support of Principal Investigator in arrangement of the processes in accordance with the valid standard operating procedures;
• training of the study team on the standard operating procedures, Good Clinical Practice and engagement of external experts for necessary trainings;
• additional support of the coordinator to the Principal Investigator and team of study physicians via delegation of administrative powers to the coordinator in accordance with the Site Standard Operating Procedures;
• additional quality control of the obtained data by the experienced coordinator

Moreover, SMO provides convenient work with the site for the Sponsor owing to:

• the presence of the experience coordinator as the contact person for the Sponsor representatives which allows to get the necessary information and responses to inquires in shorter terms;
• arrangement of payments to volunteers;
• support in execution of agreements with the institution which allows to make it in shorter terms.