FibroGen - a company trying to commercialize synthetic collagens and gelatins

Recombinant human collagens and gelatins
Based on expertise in collagen and the role of prolyl hydroxylase enzymes in the formation of collagen, FibroGen has developed the first known recombinant methodology for making fully synthetic collagens that are essentially identical to those found in nature. By making and testing different types of collagen that exist in nature, FibroGen scientists have demonstrated that recombinant type III collagen persists longer in tissue than any form of human or animal type I collagen. This unique characteristic of type III collagen serves as the basis for FibroGen's dermal filler product candidate for cosmetic applications.
Focused efforts over several years have also led to the development of a highly efficient production system employed by FibroGen to supply recombinant human collagens and gelatins (collagen fragments) as biomaterials for use in a variety of pharmaceutical and medical device applications. FibroGen produces recombinant human type III collagen (never before available in commercial quantities), recombinant human type I collagen, and distinct recombinant gelatin molecules optimized for specific applications. FibroGen's biomaterials address the needs of a wide range of customers in the pharmaceutical and medical device industries for safer, highly pure, and fully characterized alternatives to animal-sourced collagen and gelatin.

FDA moves to prevent Mad Cow Disease infecting Hemostat's and other Devices

The FDA is moving (some would say with glacier-like speed) to barr deadly prions from contaminating humans and animals via prohibiting the use of "high risk" animal products being used in drugs, biologics and medical devices (e.g. hemostat's) intended for humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.

The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:

the brain, skull, eyes and spinal cords from cattle 30 months and older;
the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
any material from "downer" cattle--those that cannot walk;
any material from cattle not inspected and passed for human consumption;
fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
mechanically separated beef.
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Collagen from Plants

CollPlant Ltd. is a biotechnology company specializing in the development and commercialization of safe, plant-derived collagen and protein-based biomaterials for the healthcare industry.

Collagen is one of the primary materials found in a variety of medical products including bone growth matrices, facial aesthetics, wound dressings, hemostats and sealants. During the last few years public awareness of the potential hazards of animal-derived collagen has begun to drive the healthcare industry to seek alternative sources for collagen.

CollPlant has developed a proprietary transgenic plant-based expression and production system for safe, high-quality, Type I recombinant human collagen. The Company's plant-derived collagen has an enhanced safety profile, as it is free of potential viral and other animal-derived hazards such as prions associated with Mad Cow Disease. In addition, CollPlant's transgenic plants are grown and cultivated within a completely sealed, environmentally-safe greenhouse.

In addition to its Type I collagen product, CollPlant is developing an extensive pipeline of additional high value, plant-derived protein polymers and composites with a variety of specialized characteristics tailored to specific markets such as orthopedics, aesthetic medicine, urinary incontinence, and wound healing.

CollPlant was founded in 2004 by a group of leading scientists, and is spearheaded today by experienced market-oriented executives from the global biotechnology arena.