Biovel Life Sciences (P) Ltd is planning to introduce a range of vaccines and therapeutic proteins in the domestic market by mid 2008. These are Polysaccharide vaccines for Typhoid and Hib (Haemophilias Influenza-B) vaccine, a remedy for fatal brain infection in babies. The vaccines have been tested at Central Research Institute, Kasauli and approved for clinical studies.
The company has an established procedure to conjugate PRP with the protein to convert B-cell dependent vaccine to T-cell dependent vaccine. This method increases the safety and applicability of vaccine. Biovel is also working towards conjugating Vi-polysaccharide with a protein to increase its applicability. The conversion of bio-similar polysaccharides into bio-superiors will help to increase immune response of the product and enable better and wider applications, Dr Durgaprasad Annavajjula, director, Technical, Biovel Life Sciences (P) Limited told Pharmabiz.
The Indian market size for typhoid vaccines is Rs 25 crore with GSK being a major player among others. The HiB market is valued at Rs 100 crore, informed P. Sudhakera Naidu, chairman and managing director Biovel.
The company is also working on a comprehensive, effective and affordable wound management system in collaboration with national and international institutes. The wound management system will be for a variety of products for a specific application.
The highlight of the system is the gel which contains cocktail of growth factors required for wound healing at different stages especially for chronic conditions. "The development of the wound management system is a first-of-its-kind effort by a biotech company in the Asian region," according to Biovel officials.
The Sodium Enoxaparin (Thrombovel) introduced in four different strengths has been well accepted in market and made its entry into some of the leading hospitals in India. With regards to global market entry, Thrombovel is in the process of registration in the non-regulated countries. Biovel has tied-up with a leading Indian company (name withheld) to co-market the brand in selective international markets.
On the technology transfer of Pfenex Expression to manufacture Human Growth Hormone (HGH), Biovel is in the process of importing the clone. Permissions from regulatory authorities have been sought to conduct the experiments at its facility. This is expected to be one of the prestigious products in our portfolio, stated Dr Annavajjula.
Biovel is aggressively pursuing its CRAMS project and is in discussions with a European major for a strategic alliance. The validation of its main production plant located at Hoskote in the outskirts of Bangalore is on. In the meanwhile several enquires for the contract manufacturing and fill finish work from both India and abroad have come in which would be finalized soon.
Its advanced multi product manufacturing facility built according to USFDA norms can produce four products simultaneously. A regulatory consultant, from US visited our facility on-behalf of a US based customer and expressed his satisfaction with our facility, stated Dr Annavajjula.
The production unit infrastructure consists of two cGMP pilot plants for in-house or contract works. The total clean room area spans over 40,000 sq. ft. There are two independent vial fill finish lines, one of which is attached to the lyophilizer besides an advanced PFS system. The facility can simultaneously produce three independent biologicals using 20 litre, 100 litre and 300 litre fermenters followed by downstream processing and purification systems. In addition, there is also a state-of-the-art water purification system which can support the needs of the production unit.