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.
- 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 Republican State Enterprise on the Right of Economic Management “Research Institute for Biological Safety Problems” of the Ministry of Health of the Republic of Kazakhstan is located far from large populated areas in a separate military town, fenced and guarded from unauthorized persons. The production facility itself is equipped with all-round physical protection, consisting of a concrete fence, equipped with razor wire on top. The entire perimeter of physical protection is equipped with video cameras, through which round-the-clock surveillance is conducted via a monitor. The entrance and exit to the territory of the production site is guarded by a special security service, and access to this territory is carried out with special passes, issued with the permission of the general director of the enterprise.
Cell Cultivation Laboratory
The Cell Biotechnology Laboratory occupies the second floor of facility #92, 12 rooms on the third floor, and 5 rooms on the first floor.
The laboratory’s work boxes are equipped with an alarm, bactericidal lamps, and supplies of disinfectants. The walls are tiled, and the work tables in the boxes are made of a material resistant to disinfectants. Upon entering the sterile box, each staff member puts on individual sterile clothing – a gown, a headscarf, and a disposable mask.
In the primary group, work is carried out on the preparation and seeding of cells after trypsinization obtained from various organs of animals (LAM – lamb kidneys, LA – lamb testicles, PT – calf kidneys, TT – calf testicles, ECO – sheep embryonic skin, PP – piglet kidneys, PS – puppy kidney, PK – rabbit kidneys) and birds (KEF – chicken embryo fibroblasts). This box belongs to the “conditionally clean” zone, since there is a risk of infection with microorganisms of pathogenicity groups 2-4 when working with organs (sheep embryo, lamb kidneys and testicles, chicken embryos) taken from animals and birds.
In the group working with transplantable cell lines, work is carried out with cultures of various origins, MDVC – normal bull kidney, RK-15 – rabbit kidney, TT – calf testicles, CV – kidneys of the green African monkey, blood serum of various animal species, which, as a rule, may contain mycoplasmas. The following types of work are carried out in the laboratory:
– preparation of nutrient media, glutamine, EDTA, trypsin, serum, soda and checking their sterility. Here, sealing of ampoules with cell culture suspensions is also carried out, which are placed for long-term storage in liquid nitrogen;
– maintenance of continuous cell lines described above;
– work is carried out to sterilize nutrient media, solutions of soda, EDTA, trypsin, glutamine, and blood serum;
– disinfection measures are regularly carried out in rooms where cell cultures are worked with and media and solutions are prepared;
– biological waste is disinfected by autoclaving. There is a fire alarm system. The building is locked with a combination lock and an iron door
Virus Cultivation Laboratory
The Microorganism Cultivation Technologies Laboratory is a complex consisting of a laboratory facility located in a three-story building occupying an area of 313.2 sq. m. The laboratory has 1 separate entrance for personnel, clean material and biomaterial. The laboratory is divided into two zones: “clean” and “conditionally clean”.
The “clean zone” is equipped with forced exhaust and supply and exhaust ventilation with fine filters. This zone has four boxes in which work is carried out with vaccine strains of microorganisms.
The “Clean Zone” includes a thermal room, which is designed to maintain a certain temperature necessary for cultivating microorganisms, a room for storing vaccine liquid, which is equipped with low-temperature and household refrigerators, a box with a bioreactor installed inside designed for suspension cultivation of cell cultures and microorganisms, and a room for microscopy.
The “conditionally clean zone” contains a room for sterilization and preparation of laboratory glassware, nutrient media, a room for disinfection of infectious material, 3 offices (the office of the head of the laboratory, for senior and junior research staff), a warehouse, a bathroom with a washbasin, a canteen and a corridor with a central exit.
The windows of the boxes and other rooms of the “Clean Zone” are tightly closed, the laboratory floor is completely covered with porcelain tiles, the walls and ceiling are covered with a washing emulsion resistant to disinfectants. The walls around the washbasins are tiled in the form of aprons. In the conditionally clean zone, the floor is covered with laminate in three rooms. Telephones in the corridors are available for communication with other rooms and buildings.
In the sterilization and assembly room, work is carried out to sterilize auxiliary solutions and environments, special clothing and gowns by autoclaving and laboratory glassware by dry heat in cabinets.
Production waste is disinfected in an autoclave, followed by disposal of biomaterial and washing of dishes with cleaning agents.
The laboratory’s sewer collector is equipped with a two-stage wastewater disinfection system.
Biological waste of class “B” and “C” is rendered harmless by autoclaving and disposed of in Bekkari pits, in accordance with the Rules for the disposal and destruction of biological waste, approved by the order of the Minister of Agriculture of the Republic of Kazakhstan dated April 6, 2015 No. 16-07/307. Upon completion of work, all scientific and production premises are subject to sanitary disinfection, and all laboratory employees take a hygienic shower in the central sanitary checkpoint. There is a fire alarm system. The building is locked with a combination lock and an iron door.
Laboratory of Infectious Disease Prevention
The laboratory for the prevention of infectious diseases is a single complex consisting of two laboratory facilities and a vivarium located at a distance of at least 100 m from the facility.
The facility is located in a one-story building occupying an area of 366.5 sq. m. The facility has three separate entrances for personnel, clean material, and biomaterial. The virology block is represented by three boxes, a centrifuge room, a thermal room, a cold room, rooms for short-term and long-term storage of virus-containing materials. Entrance to the “infectious” zone is through a sanitary checkpoint with a shower, where protective clothing is put on. The entire block is equipped with forced supply and exhaust ventilation with fine filters. The block has three boxes in which experimental and production work is carried out with recombinant and vaccine strains of the seasonal influenza virus, as well as influenza viral vectors expressing brucellosis proteins (boxes No. 1 and No. 2). In addition, the laboratory has a centrifuge room (clean room), where viruses are purified and concentrated using an industrial high-speed ultracentrifuge eKII (AlfaWassermann, USA). Considering that the laboratory can change the subject of research work, it is possible to conduct research with other viruses of a higher hazard class. The windows of the boxes and other rooms of the infectious block are tightly closed. The floor, walls to the ceiling in the boxes are lined with easy-to-clean tiles resistant to disinfectants. In the pre-box room of each box there is a sink with a sensor switch for hand washing and a supply of disinfectants. For communication with other rooms and buildings, there is a telephone in the corridor and additional intercoms in the corridor, boxes No. 2 and No. 3, on the street.
At the end of work, a hygienic shower is taken in the shower room, which separates the infectious and conditionally clean zones, and clothes are changed – at the exit from the infectious block in the shower room, and at the end of the working day – in the central sanitary checkpoint.
The laboratory has certified biological safety cabinets, an incubator for 16 thousand chicken embryos, drying cabinets, thermostats, water baths, laboratory centrifuges, and autoclaves.
The virus-containing material produced for the production of vaccines is stored in a sealed cold room (2-8ºС) or low-temperature refrigerators (minus 40-70 ºС). Intermediate (bulk) vaccine products are stored in household refrigerators (2-8ºС) boxes, and finished vaccine preparations are transferred for secure storage to a finished product warehouse.
In the sterilization and assembly room, work is carried out to sterilize auxiliary solutions and environments, special clothing and gowns by autoclaving and laboratory glassware by dry heat in cabinets.
Production waste is disinfected in a pass-through autoclave, followed by disposal of biomaterial and washing of dishes with cleaning agents.
The laboratory’s sewer collector is equipped with a two-stage wastewater disinfection system. There is a fire alarm system. The building is locked with a combination lock and an iron door.
Laboratory of finished forms of biopreparations
The technical equipment of the laboratory allows performing work on sublimation drying of biopreparations produced at the Research Institute of Bioorganic Bacteria, such vaccines as vaccine against sheep pox, contagious ecthyma of sheep and goats, peste des petits ruminants and other lyophilized vaccines and diagnostic preparations, and the equipment of the laboratory allows for the preparation of emulsified inactivated vaccine against bird flu. The laboratory also includes a workshop for sublimation drying of biopreparations and a vivarium (isolator).
The laboratory for the “technology of finished forms of biopreparations” consists of three floors.
First floor
The left wing contains: one class A clean room, a class C washroom, a box, a class C labeling room, a class C room for preliminary storage of biological products, a toilet and a changing room.
The right wing contains: a sanitary checkpoint, an autoclave, a technical block, and three boxes.
The sanitary checkpoint is intended for the sanitary treatment of personnel and changing of special clothing, for which there are showers. The floors of the premises are tiled, water supply, sewerage.
All rooms in the right wing of the first floor are equipped with an exhaust ventilation system, water supply, sewerage and heating, and are connected to a compressor system for spray treatment of production areas.
Second floor
The left wing contains three offices, a laboratory technician room, a microscope room, a thermal room, and a washing room.
The right wing contains a refrigeration room and an autoclave room.
The floor of the room is tiled, there is a ventilation system, heating, water supply, sewerage. The box is equipped with bactericidal lamps and fluorescent lamps.
Third floor
On the third floor there are technical rooms, where the laboratory exhaust ventilation system (air purification filters) is located, designed to clean and neutralize the air in boxes and other production areas.
Testing laboratory “Control of technology and biopreparations”
The main task of the laboratory “Control of technology and biopreparations” is to conduct quality control of the biopreparations produced by the Research Institute of Bioorganic Bacteria. The laboratory also conducts virological, microbiological, serological and molecular biological studies with microorganisms.
The laboratory “Control of technology and biopreparations” consists of three blocks: biological, microbiological and chemical.
In the biological block, work is carried out to determine the biological activity and biological properties of microorganisms, identify and detect viral and bacterial diseases. After receiving and registering in a special room, samples are transferred to the box rooms for testing. In the box, work is carried out on sequencing virus genes. Research work is also carried out to determine the biological activity and biological properties of microorganisms on cell culture. Neutralization reactions are set up, work is carried out to determine the biological activity of lyophilized vaccines (sheep pox, nodular dermatitis of cattle, pustular dermatitis of sheep and goats, camel pox, etc.). In the box rooms, work is carried out to identify and detect viral and bacterial diseases using the PCR method. Serological reactions are carried out when monitoring the vaccine against bird flu.