Infrastructure

BSL-3 Animal Facility

Biosafety is a major concern in every biomedical and medical setting across the world. The need of instituting biosafety and biosecurity norms/measures is increasing due to the possible dual use of microbial pathogens and increasing awareness. Laboratory associated infections (LAI) have caused diseases and fatal outcome to laboratory workers due to absence or failure of any one of the four basic controls (Engineering, Personal Protective Equipment, Standard Operating Procedure and Administrative Controls) of biosafety.

We have India’s 1st, World’s 2nd BSL-3 + Ag Production Animal Facility. It is a Global Standard Facility with INR 150 Cr Investment. It is also a BSL-3 + Ag Large Animal Testing Facility located at Bengaulru

Research & Development

“We aim to develop novel Animal Vaccines by leveraging our exceptional scientific talent pool and developmental capabilities”.

Biovet’s R&D division is engaged in the development of products and processes, and in transferring the technologies to the production section. The focus is on infectious emerging and reemerging diseases of animals with the aim to bring out economical products in the health care segment. From a one-product company Biovet has growing to a multi-product company because of its in-house R&D and process development. Scientists from various disciplines such as microbiology, biotechnology, and biochemistry work on novel and conventional technologies to develop vaccines, diagnostics, monoclonal antibodies and biologicals.

Collaborations with national and international organizations help to bring in the latest concepts and methods in product development. Scientists working in various projects interact and complement each other’s technical knowledge and skills. This provides a vibrant atmosphere for innovation and improvement.

Scientists from various disciplines such as microbiology, biotechnology, and biochemistry work on novel and conventional technologies to develop vaccines, diagnostics, monoclonal antibodies and biologicals.

Collaborations with national and international organizations help to bring in the latest concepts and methods in product development.

Scientists working in various projects interact and complement each other’s technical knowledge and skills. This provides a vibrant atmosphere for innovation and improvement. Biovet has research collaborations with several reputed national and international institutes including:

Biovet Private Ltd., partners some of the world’s finest Institutions and organizations.

Manufacturing

Biovet’s world-class facility in Malur, Karnataka has the following manufacturing infrastructure:

  1. Foot & Mouth Vaccine Manufacturing Plant
    • Ultra Modern / High-tech Bio-containment BSL 3+ facility at Malur.
    • Battery of Fermentors with different capacity for manufacturing of FMD Vaccine
    • Online Medium filtration.
    • Dedicated areas for both virus & Cell culture as per OIE, WHO, GMP specification.
    • Production area is as per OIE / WHO / GMP specification.
    • Concentration of virus assembly and Antigen Bank.
    • Antigenic mass estimated as 146s protein.
    • Production area is as per BSL 3+ Specification i.e., 5 meters below soil level ETP, Kill tank- In built 5 meters below soil level and drain to main ETP (Effluent Treatment Plant).
  2. Filling & Formulation
    • Online Blending & Formulation.
    • Mixing of adjuvant with Yastral pump for Micronization.
    • Online automated filling & sealing facility.
    • Online Vaccine Labeling and cold storage.
  3. Animal Challenge Facility
    • Animal challenge experimental facility having BSL-4 Bio-containment facility having in built incineration facility.
    • Dedicated Serological lab.
    • Small Animal Experiment Room.
    • Documentation.
  4. Quality Operations
    • Instrumentation, Water testing, Raw material testing, Packing material testing, Online quality process control, Virus titration, Purity, virus innocuity In-vivo and In-vitro as per IP 2007.
    • Product sterility, safety, efficacy and potency.
    • Serological & microbiological lab.
    • Walk in cold room facility (+4°C and -20 °C).
    • Shaker culture, CO2 incubator & cell culture testing facility.
  5. Warehouse
    • Finished goods demarcated area as per GMP standard warehouse.
    • Raw material substantial storage area.
    • +4°C for vaccine storage facility.
  6. Engineering, Maintenance & Utility Services
    • Steam generation plant.
    • Demineralised water plant.
    • Reverse osmosis plant.
    • 610 KVA standby power generator.
    • Air compressor.
    • Air handling unit (AHU).
    • Water for injection plant.
  7. Transformer Yard Capacity:
    • 950KVA with a backup generator for uninterrupted power support.
  8. Environmental Health and Safety
    • Effluent treatment plant (ETP).
    • Incinerator for disposal of Biowaste.

Quality Assurance

The assurance of quality starts from the Raw Material itself as soon as it enters the premises. It goes without saying that Qualification studies are mandatory for all equipment and all production and analytical procedures are validated. The stringency of control can be adjudged by the challenge that the production of vaccine.

The Quality Assurance department is well equipped with a huge investment in men and machines. The entire process is managed with the State-of-the-art ERP system, which controls and provides instant information on every aspect of Production and Quality Control. The QC of massive batches of FMD vaccine is a challenge in itself. All this has been possible with the high work ethic that ensures that every safeguard is instituted and every norm of cGMP is scrupulously followed.

Complementing our team of competent and experienced personnel is the wide array of sophisticated analytical equipment. With these, our scientists have developed and adapted special tests, ensuring Total Quality Management.

Testing

In adhering to our quality principle, every product from the Biovet stable is put through an array of stringent tests. Biovet has world-class infrastructure to carry out the following quality tests:

In Process Tests:

  • Virus Testing (Titer, Purity)
  • Virus Inactivation (Innocuity – Invitro and Invivo)

Quality Control Tests:

  • Water Testing
  • Raw material testing
  • Packing Material Testing
  • Cell Growth Promotion test
  • Concentration of Antigen (146s), Sterility, Safety
  • Virus Inactivation (Innocuity – Invivo)

Finished Product Tests:

  • Sterility
  • Safety
  • Efficacy
  • Potency