The production of biological products for use in veterinary medicine dates back to 1921, when Veterinarski Zavod Subotica was founded. This makes us a reference institution for the production of serums and vaccines against infectious diseases of animals, not only in the country but in the Balkans region as a whole.
Since we are part of Labiana group, our goal is to promote and expand our services of CMO biological manufacturing as well as our own range of biological products worldwide. Commitment is our benchmark to become a new reference in the field of biological manufacturing internationally. We rely on a rich experience of almost 100 years: our manufacturing capacity and our portfolio of biological products has grown along the years. Nowadays, it includes inactivated and live, bacterial and viral vaccines as well as autogenous vaccines against various infectious diseases and for different species and categories of animals.
Veterinary vaccines are used for prevention of diseases that affect animals. They are complex biological products with lengthy manufacturing and control processes. At Veterinarski Zavod Subotica customers can find not only the appropriate facilities, complying with the standards defined for Current Good Manufacturing Practices (cGMP), but also a qualified and experienced team who looks after with accuracy all the operations.
Quality is our flagship: successful manufacturing of high-quality vaccines requires international standardization of starting materials, production and quality control testing, and the setting of high expectations for regulatory oversight of the entire manufacturing process from start to finish, all while recognizing that this field is in constant change.
These strong quality requirements involve ad hoc pharmaceutical quality systems, quality assurance measures and procedures, several quality controls at each stage and an adequate infrastructure and separation of activities to guarantee vaccine identity, purity, sterility, efficacy and safety.
The facility for the production of inactivated bacterial vaccines is EU-GMP certified and covers an area of 1,315.74 m2. In terms of layout, cleanliness class and air conditioning, the production space is in complete accordance with the following conditions: EU-GMP guidelines (Annex 1 Manufacture of Sterile Medicinal Products and Annex 5 Manufacture of Immunological Veterinary Medicinal Products), WHO Biosafety guidelines (Laboratory biosafety manual: Third edition and Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities) and the Rulebook on Preventive Measures for Safe and Healthy Work When Exposed to Biological Hazards.
Veterinarski Zavod Subotica produces inactivated bacterial vaccines in a complex process consisting of 14 phases. Inactivated bacterial vaccines are usually combined with an adjuvant (oily adjuvant or aluminum hydroxide) to stimulate the host immune response and increase the stability of the product. At Veterinarski Zavod Subotica we also manufacture our own brand bacterial vaccines:
Viral vaccines are preparations of viral antigens (lyophilized or combined with an adjuvant) that effectively induce the body's immune response. The facility for the production of viral vaccines is GMP certified and covers an area of 889.87 m2.
For the production of viral vaccines, we use a virus, an infectious strain and, unlike bacterial vaccines, we need a living organism in which the virus will multiply. According to the affinity of the virus for various living organisms, at Veterinarski Zavod Subotica we carry out production in two ways:
The production of viral vaccines on cell lines is carried out in 10 phases: The production of viral vaccines on fertilized eggs is carried out in 12 phases. At Veterinarski Zavod Subotica we also manufacture our own brand virus vaccines: