Diagnosis, prevention, medicine

About company

Directions of activity

  • Developments of diagnostic platforms for detection of human and farm animal infections.
  • Development and manufacturing of diagnostic products for laboratory medecine - enzyme-linked immunosorbent assays (ELISA), PCR test kits.
  • Scientific developments in the field of diagnostic device assessment.
  • Production of human sera panels intended for use in sensitivity and specificity assessment of commercial diagnostic ELISA-based kits, external control and testing the work standards of clinical diagnostic laboratories.
  • Production of recombinant protein monoclonal antibodies for diagnostic purposes.
  • Scientific development of immunobiologicals.
  • Production of immunobiological substances.

 

Quality management system

The quality management system ISO 13485 is designed and realized in JSC "Diaproph-Med". The company was certified by mdc medical device certification GmbH (Germany) in 2006.

 

Intellectual property

Intellectual property rights are protected by twenty-one declarational patents for a utility model. PJSC "SPC" Diaproph-Med" has the rights of property on the signs DIA® and DiaProph•Med® (Certificate for a sign for goods and services #60088 and #60948).

 

 

Products

 

  • 34 ELISA-based assays for laboratory diagnostic of human infections:
    • 7 for diagnostic of HIV-infection,
    • 8 for diagnostic of hepatitis B and C,
    • 19 for diagnostic of ToRCH-infections;
  • 6 PCR test kits:
    • 11 for diagnostic of influenza virus  type  H1N1 (avian influenza),
    • 1 for diagnostic of influenza virus type H5N1 (swine influenza),
    • 1 for simultaneous determination of hepatitis , C and HIV-1,
    • 3 for determination of HIV-1.
  • 6 ELISA-based assays for diagnostics of infectious diseases in farm animals:
    • 1 for diagnostic of leukemia ,
    • 2  for diagnostic of brucellosis,
    • 1 for diagnostic of tuberculosis ,
    • 1 for diagnostic of trichiniasis,
    • 1 for diagnostic of avian influenza.
  • 18 panels of human sera.
  • Substance of human recombinant interferon alfa-2b.
  • Veterinary immunobiologicals – human recombinant interferon alfa-2b.
  • Recombinant analogs of antigens of infection coasing agents for human and farm animals: monoclonal antibodies, which recognize human and cattle immunoglobulins, and also virus-specific antigens.

CEO – Chairman of board Olexander Shevchuk

 

Personnel

95 workers: managerial staff  – 9; personnel of management/quality assurance – 16; personnel involved in quality control – 10; personnel, involved in production – 20, scientific personnel – 30.

 

Areas

Production has 60 scientific production  areas and laboratories, 37 auxiliary rooms.  Total area is 2 000 m2.

 

R&D department

Research and development department provides the information about advances and trends in biotechnology. R&D department is responsible for creating innovative new products and improvement existing consumer products.

R&D department consists of four laboratories:

  • Laboratory of immunochemistry;
  • Laboratory of biotechnology;
  • Laboratory of hybridoma technology;
  • Laboratory of chemical synthesis.

Activities:

  • Development of E.Coli strains producing recombinant proteins; optimization of cultivation conditions of recombinant bacterial strains.
  • Development of purification protocols for recombinant antigens and monoclonal antibodies.
  • Development of hybridomas producing monoclonal antibodies of defined specificity.
  • Development of technology for conjugation of horseradish peroxidase and/or biotin to recombinant antigens and/or monoclonal antibodies using chemical cross-linkers.
  • Preparation of recombinant proteins, monoclonal and polyclonal antibodies, biotin or horseradish peroxidase conjugates on the request of manufacturing department.
  • Chemical synthesis of affine resins for antibodies and antigens purification.
  • Implementation of chromogenic substrates and preservatives synthesis, and also production of such products on the request of manufacturing department .
  • Development of strategies for stabilizing of different test kits compounds.
  • Construction of ELISA-based assays.
  • Advisory and educational activity.

 

Marketing department

The marketing department is responsible for coordination in manufacture, sales or distribution of products.The activity of department aimed at manufacture of competitive products, corresponding to established requirements, in defined amount according to market supply and demand. The head of marketing department coordinates and manages the department activity in relation to market research, order analysis, celebration of contracts, product deliveries, organization of after-sales service for consumers.

 

Manufacturing department

The manufacturing department consists of 9 subdivisions. It provides complete manufacturing of high quality production.

 

Department of biotechnological control

The department of biotechnological control is responsible for turn-off control. Department employers monitor the product quality during the storage with the aim to avoid delivery of low-grade products to consumer.

 

Department of product control

The department of product control monitors the quality of intermediate products, raw materials with the aim to avoid delivery of low-grade production to consumer.

 

Group of monitoring and audit

The group is responsible for internal audit of subdivisions, monitoring and gauge the effectiveness of the process, controls an execution of plans and programs, hands over important information to the board of directors, provides the control of quality  protocols in accordance to ISO 13485 Standard requirements.

 

Service of the quality management system ensuring

The group ensures the proper performance of the quality management system.

 

Registration group

The group is responsible for the drawing up the documentation for abroad registration of company production and for the registration of new production in accordance to requirements of normative and regulatory documents  of Ukraine and European Union related to medical and in vitro diagnostic devices.

 

Supply department

The department is responsible for supply of the company with all material resources required for manufacturing and scientific activity (raw materials, fuel, complementary furnishings, labware, replacement parts, working clothes, household equipment and others).

 

Storage facility

The facility includes raw material storage, intermediate and final product storages. All storage rooms are outfitted with the cooling, control and measuring equipment and provide the proper production storage.

 

Service facility

The facility includes engineering, metrological, labor protection services, personnel department and technological division.