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Guryev

Artem M.

Director of Pharmacy

Телефон: 8 (3822) 901-101 (extens. 1859)
Адрес: 2g Moskowski Trakt Street, building 18, room 10
Analytical laboratory: 8 (3822) 901-101 (extens. 1864)
Pilot-scale production unit: 8 (3822) 901-101 (extens. 1865)
Clean room facilities – material preparation: 8 (3822) 901-101 (extens. 1868)
Clean room facilities – manufacturing of active pharmaceutical substances: 8 (3822) 901-101 (extens. 1871)
Clean room facilities: 8 (3822) 901-101 (extens. 1869)
Электронная почта: center.vner.teh@ssmu.ru


Technology Implementation Center deals with development and implementation of technologies for production of active pharmaceutical substances and dosage forms, medical devices and diagnostic kits, as well as dietary supplement and cosmetic products. Pilot-scale production of SSMU Technology Implementation Center, designed in accordance with GMP EU, totally meets the requirements of the Russian and European standards for premises and equipment of the pharmaceutical industries.

Our area of competence includes development of production technologies, elaboration of standardization methods, technological regulations and instructions, monographs, specifications, and other regulatory documents as well as organization of pre- and post-clinical studies (including bioequivalence), compiling of registration dossiers and support of the process of state registration and certification of new products for human and veterinary medicine.


Directions of activity:

Development of technologies and manufacturing of pilot runs:

  1. Of innovative drugs
    • inventive substances (active pharmaceutical substances)
    • me-too drugs
    • well-known drugs with new prescription
    • new (including innovative) drugs with known APS

  2. Of generic drugs
    • with expiring patent
    • orphan drugs

  3. Of parapharmaceutical production
    • diagnostic kits
    • dressing materials
    • biologically active additives
    • cosmetics

Characteristic features of Technology Implementation Center:



  • Total area of production floor – 280 sq.m.
  • Total area of private premises – 180 sq.m.
  • Availability of clean zones of all classes, including those for production of injectable medications.
  • Number of personnel – 14 people including 4 DSs and 2 PhDs.

  

Advantages of cooperation with Technology Implementation Center:

  1. High flexibility of pilot production – the opportunity to manufacture a wide range of products
  2. Availability of pilot and industrial equipment allowing to practice parameters of a real manufacturing process
  3. Compliance of processes and equipment with the GMP requirements – testing of industrial processes and document flow at the project stage and their further transfer to industrial production
  4. Target staff training – attraction of students and post-graduates from SSMU and other universities to work on the project with their subsequent move to the production under formation
  5. The use of research potential of SSMU and other scientific organizations of Siberia
  6. Turn-key development – from an idea to a working draft of production, including organizational technological documents and staff provision.


Who we are working for

  • Scientific workers of SSMU, working on development of new products and technologies for medicine, pharmacy and veterinary medicine
  • Students, interns, post-graduate students and university teacherswho plan on working with science and innovative business
  • Research teams from external educational and R&D institutions, engaged in development of products for medicine and pharmacy
  • Private companies – developers of drugs and medical devices
  • Pharmaceutical companies and manufacturers of medical devices, who wish to expand the assortment of manufactured products or improve the existing production technologies
  • Manufacturers of pharmaceutical and laboratory equipment
  • Private or institutional investors, working in the area of venture capital financing.