Saturday, June 14, 2008

Recombinant collagens and synthetic gelatins

FibroGen is the only producer of highly purified, fully characterized recombinant collagens and synthetic gelatins intended to replace similar animal- or plasma-derived materials currently used in a variety of medical, pharmaceutical, and consumer applications. The company's fermentation system enables the large-scale production of medical-grade materials. FibroGen's collagens and gelatins are fully synthetic materials that eliminate the risk of contamination with disease-causing pathogens such as viruses and prions. Currently FibroGen's products are intended for laboratory research purposes only and are not to be used in humans or for any other purposes, including but not limited to, in vitro diagnostic purposes, foods, drugs, medical devices or cosmetics or animals or for commercial purposes.

Autologous Products

Scandanavian company Vivolution sells their product range the Vivostat® System in Europe comprising two groups of products that utilize the same patented technology. The Vivostat®System is an automated system for the on-site preparation and application of patient-derived fibrin sealant or platelet rich fibrin (PRF®). It incorporates a unique and patented biochemical process that produces an autologous sealant from 120 ml of the patient’s own blood in only 23 minutes.
Vivostat® autologous fibrin sealant is used during surgery to prevent and stop bleedings and oozing of body fluids.
Vivostat® PRF® autologous platelet rich fibrin is used to promote cell growth for a range of procedures e.g. orthopaedic surgery and wound healing.

PlasmaSeal has designed three devices (called Cebus, Ateles, and Proteus) that produce Platelet Plasma Concentrate from the patient's own blood. From a regulatory perspective PPC is an autologous blood product. PlasmaSeal PPC technology is remarkably simple to use. Depending on the extent of wounded area 10 to 100 cc of blood is withdrawn from the patient and immediately mixed with standard citrate anticoagulant. The platelet plasma is separated from whole blood by centrifugation, then it is concentrated by removing some of the salt water. This second step can be accomplished in many ways. A simple method, called hollow fiber concentration uses small tubes with special walls, which are porous to salt water but not to the larger proteins and platelets in blood. It is this basic procedure and two step method that is used in all the devices.

Thermogenesis offer the advanced CryoSeal® FS System a new generation of performance for the production of fibrin sealant. The system safely and conveniently extracts high-quality fibrinogen-rich cryoprecipitate and thrombin from a single unit of autologous or allogenic plasma in approximately 60 minutes. Also the advanced Thrombin Processing Device (TPD™) provides busy operating rooms and other fast-paced environments with a rapid, safe, easy-to-use method for producing active human thrombin from either plasma or whole blood.
Inoteb has developed what it believes to be the world's first fully autologous biological glue. This Autologous Biological Glue is prepared using the patient's own blood, in a closed system, eliminating immunologic problems and the risk of blood-borne disease transmission such as, for example, HIV and hepatitis. In contrast, all surgical glues currently on the market (whether autologous or homologous) require foreign proteins such as thrombin or antifibrinolitic agents. Clinical trials have been done especially for skin replacement and skin grafts eliminating the need for protein based skin grafts.In its use to date in European trials, the Autologous Biological Glue has been shown to be clinically safe and effective. Biocoral, Inc. will continue to push through the clinical trials examining the use of the Autologous Biological Glue for cosmetic applications, utilizing well-known plastic surgeons in Europe and the United States.