State Enterprise on the Right of Economic Management “Research Institute for Biological Safety Problems” of the Ministry of Health of the Republic of Kazakhstan
The Scientific Research Institute for Biological Safety Problems LLP of the Ministry of Health of the Republic of Kazakhstan is located in an isolated, guarded military township, remote from large populated areas, and is equipped with a round-the-clock physical security system.
The Institute operates several specialized laboratories:
– Cell Culture Laboratory – conducts preparation, seeding, cultivation, and sterility control of cells derived from various animal and avian species.
– Virus Cultivation Laboratory – equipped with modern ventilation systems, bioreactors, and instruments for cultivating vaccine strains of microorganisms, as well as for the storage and sterilization of materials.
– Laboratory for the Prevention of Infectious Diseases – carries out experimental and production work with recombinant and vaccine virus strains, including seasonal influenza viruses. The laboratory is equipped with biosafety boxes, a ventilation system, autoclaves, and refrigeration units.
– Laboratory of Finished Biological Products – performs lyophilization (freeze-drying) and preparation of various vaccines and diagnostic preparations produced by the Institute.
– Testing Laboratory “Control of Technology and Biological Products” – conducts quality control of the Institute’s biological products, as well as virological, microbiological, and molecular-biological studies.
TOO “OtarBioPharm”
Domestic manufacturer – OtarBioPharm LLP began its activities in 2021.
In 2020, a production site was organized in the Zhambyl region and the authorized body issued a license to engage in activities related to the production of medicines. The company began to carry out secondary and tertiary packaging of medicines.
The construction of the plant was completed in June 2021, the workshop building was put into operation and the authorized body issued an appendix to the license for the implementation of activities for the production of pharmaceutical products.
The production site of OtarBioPharm LLP carries out its activities on the basis of:
- state license for pharmaceutical activity No. 21021475 dated 06/29/2021.
- Appendix No. 001 to the state license “Production of medicines” No. 21021475 dated 06/29/2021.
- Appendix No. 002 to the state license “Wholesale of medicines” No. 21021475 dated June 29, 2021. Licensor: Republican State Institution “Department of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan for Zhambyl Region”. Ministry of Health of the Republic of Kazakhstan.
In 2022, a total of 11 series of the QazCovid-in®️ vaccine were released – an inactivated vaccine against COVID-19, with a total volume of 35,000 vials, 1.5 ml/3 doses per vial, 105,000 doses in one series.
In OtarBioPharm LLP, the equipment intended for the production of medicines meets the requirements of the GMP standard, which is confirmed by qualification documents.
JSC “Scientific Center of Anti-Infective Drugs”
“The pilot production is a structural subdivision of JSC NCPP, created in 2008 on the basis of the RSE Scientific Center for Anti-Infectious Drugs, and includes:
- liquid dosage forms production area;
- solid dosage form production area;
- area for the production of sterile dosage forms.
The pilot production operates on the basis of the State License for Pharmaceutical Activity No. 14007640 dated 05/28/2014 and Appendix No. 001 “Production of Medicines, Manufacturing, Wholesale and Retail Sale of Medicines”.
In 2019, the site for the production of liquid dosage forms was accredited for compliance with the requirements of good pharmaceutical practices in the field of circulation of medicines. From February 14 to 17, 2023, an inspection was conducted for compliance with the rules of good manufacturing practice of the Eurasian Economic Union (Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 77 “On approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union”).
The main purpose of the pilot production within the Scientific Center is to implement into practice the planned developments of laboratories of new chemical substances and materials (previously, the laboratory of physical and bioorganic chemistry), pharmaceutical chemistry of pharmaceutical technology; the use of pilot industrial technologies (scaling of laboratory technologies) for obtaining new substances and finished liquid and solid dosage forms, including the development and improvement of technological parameters of production processes and the development of regulatory and technical documentation in accordance with the requirements of GMP standards, the organization of small-scale production of substances and finished dosage forms based on them in accordance with the requirements of the GMP standard for conducting clinical trials, and in quantities that meet the needs of the domestic pharmaceutical market.