Bharat Biotech International Limited has crossed production and delivery of more than 150 million doses of Revac-B, recombinant hepatitis B vaccine since its launch in October 1998.
Revac -B has been marketed and sold in more than 30 countries worldwide with manufacturing and quality standards on par with US FDA, EMEA and WHO guidelines. The vaccine has established an excellent safety and efficacy profile since its launch 10 years ago.
According to Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, the next Generation Revac-B mcf (Thiomersol and Cesium Chloride Free) Recombinant Hepatitis-B Vaccine manufactured by the company is cost-effective and addresses the safety concerns expressed by parents and members of the medical profession.
The company is a major supplier of the Cesium Chloride Free Hepatitis-B Vaccines. It has taken steps to ensure a smooth transition for customers from the traditional Hepatitis-B vaccine to the new preservative-free Revac-Bmcf vaccine apart from effectively upgrading and optimizing production technologies to ensure the phasing out of thiomersol as preservative in some of BBIL products.
Revac-Bmcf vaccine contains the same components utilized in the company's previous Hepatitis-B vaccine, but now it is supplied preservative-free in a single-dose vial. It had successfully manufactured a preservative-free pediatric vaccine of a highly reputed MNC on a contract basis and the product was exported to a regulated market in Far East.
The preservative thiomersal which contains mercury is used in the production process for many vaccines. There are trace amounts of thiomersol leftover from the production process that cannot be removed, but these amounts are so small that regulatory agencies consider the vaccine to be preservative-free. The Global Advisory Committee on Vaccine Safety of WHO in its July 2006 Statement on thiomersol stated that it does not support concerns over safety of thiomersol. The Immunization Safety Review Committee of the National Academy of Sciences Institute of Medicine, USA, however, recommends for a phase-out of thiomersol as a preservative in vaccines.
The Hepatitis-B surface Antigen (HBsAg) is produced in genetically engineered yeast cells of Pichia pastoris which carry the gene that codes for the major surface antigen protein of the hepatitis-B virus. HBsAg expressed in yeast cells is purified by complex physical, chemical and biochemical processes. The resultant highly purified surface antigen assembles spontaneously into spherical particles of an average diameter of 20-24nm containing non-glycosylated polypeptides in a lipid matrix. An extensive and rigorous R&D processes characterised and confirmed that these 20-24nm spherical particles resemble the natural HBsAg protein in their antigenic properties. The efficacy and safety of the formulated Revac -Bmcf is ensured through stringent adherence to the highest standards of bio-process control and consistent Quality Assurance measures. No substance of Human origin is used in the manufacture of HBsAg protein.