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Reliance Life Sciences develops fibrin sealant for hemostasis in surgeries
Our Bureau, Mumbai | Monday, November 25, 2002, 08:00 Hrs  [IST]

Reliance Life Sciences, under its innovative medical biotech products initiative, is currently developing fibrin sealant, a natural agent for the achievement of rapid hemostasis and tissue sealing, used in a variety of surgical applications. The product, which is currently in the developmental stage at the Cell Biology Research Center at Mumbai, would be another pioneering concept of the company's medical biotechnology initiative for the Indian market.

According to highly placed sources in the company, the development process is in the advance stage now and it is likely to be ready for pilot production shortly. Once the pilot project is proved to be viable, there will not be for making it ready commercial distribution to the hospitals. “Since the product is already in use in the developed world, the regulatory procedures to approve the marketing there will not be lengthy,” the sources said. The Reliance's project is the first attempt towards this technology and once it is made available for marketing in India, the use of fibrin sealant in surgeries will become affordable to Indian patients. Currently, the cost of fibrin sealant developed by multinationals, which is already in use abroad is very high.

ReliSeal kit, the fibrin sealant, which is under development at Reliance Life Sciences, consists of key plasma derivatives. These plasma derivatives when applied, reproduces the last stages of the natural hemostasis cascade i.e., the conversion of fibrinogen into fibrin monomers and the cross linking of these to form an insoluble fibrin matrix. Its administration is facilitated through a specific applicator, which serves to hold the components in separate syringes, and provides simultaneous mixing and delivery to the surgical site. A solid adhesive coagulum possessing good tensile strength and elasticity is formed within 3-5 minutes from the time of delivery.

Two basic components of ReliSeal, Fibrinogen concentrate and Thrombin along with calcium ion and factor XIII will be dispensed in two separate syringes. The two components gets mixed at the time of application through "Y" shaped dispenser to the actual site.

Fibrin sealant, apart from its use as an adjunct to hemostasis in surgeries such as cardiopulmonary bypass, spleen and liver injuries etc, is also indicated for controlling bleeding when conventional surgical techniques such as sutures, ligature or cautery are ineffective or impractical and as a reliable means for sealing the suture line thereby preventing leakage-related complications as in the case of colostomies.

The product would offer three primary benefits to the surgeons related to wound healing such as speed, less scarring, reduced leakage and blood loss. According to sources though the product can be classified as a pharmaceutical, it is currently considered as biological as the raw materials are plasma derivatives from blood.

Reliance Life Sciences, which has recently introduced cultured epithelial bank and cord blood repository under the medical biotechnology initiative, covers cell biology (stem cells and tissue engineering), therapeutic proteins and gene therapy. In the cell biology area, there are dedicated groups working on assisted reproduction, embryonic stem cells, hematopoietic stem cells, skin cells, tissue engineering, genetics and molecular diagnostics. The company's Cell Biology Research Center in Mumbai is the first of its kind in Asia. This initiative is uniquely integrated - both horizontally across several cell biology disciplines, and vertically, from repository infrastructure through basic and applied research to the clinical environment.

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