FibroGen has developed a recombinant human collagen technology that enables the Company to respond with flexibility to diverse market demands for collagen in the medical device and pharmaceutical industries. FibroGen's production technology uses a yeast expression system and a completely defined fermentation and purification process to produce human sequence collagen. A battery of analytical tests is used to monitor the production process and to confirm the high quality and purity of FibroGen's products.

By working with over fifty companies involved in the development and production of collagen-based products, FibroGen has developed a comprehensive expertise in the formulation processes used in the major categories of these products (described below).

Dermal Augmentation
Dermal augmentation for cosmetic purposes is a rapidly growing market driven by demographics and the introduction of new products and procedures over the last decade. Bovine collagen has been the mainstay of the dermal filler market. More recent entries include products based on cell-cultured collagen derived from fibroblast cells and hyaluronic acid, a material derived from bacterial fermentation or extracted from rooster combs.

FibroGen is developing a dermal filler formulated from recombinant human collagen type III as a safer and more persistent collagen-based product for dermal augmentation applications.

Read more about FG-5017, FibroGen's proprietary cosmetic dermal filler, and dermal augmentation.

Tissue Sealants/Hemostats
Collagen has been used as a hemostat for decades to stop bleeding and to facilitate the wound healing process, and to reduce the risk of post-surgical complications. Type III collagen appears first in a wound and initiates the hemostatic process. However, type I collagen is the most readily available type in commercial quantities. With its unique recombinant technology, FibroGen can produce pure type III collagen, offering a consistent product with superior hemostatic properties compared to animal-derived collagen type I. For example, FibroGen's recombinant human collagen type III has been shown to stop bleeding faster than type I collagen in experimental models. In addition, 3-D matrix formulations (e.g., sponges) of recombinant human type III collagen demonstrate superior mechanical integrity, larger surface area, and higher hemostatic activity than bovine collagen type I in experimental models.

Drug Delivery
FibroGen's recombinant human collagens self-assemble into ordered biological structures or fibrils. Thus, any desired physical and structural forms (e.g., porous matrices, films, gels, or monofilaments) that can be fabricated from tissue-derived collagens can also be produced using recombinant collagens. Drugs may be incorporated into, or added after, the construction of the final forms. Among the advantages of using recombinant collagens in these applications is the opportunity to begin with uniform homogeneous monomolecular collagen, which enables process standardization and consistent formulation output.

Wound Healing
The use of skin substitutes in wound healing, such as for treating burns and ulcers, remains an area of large unmet medical need. Commercially available skin substitute products are primarily composed of a monolayer of fibroblast cells imbedded in a matrix of a degradable biopolymer (e.g., collagen, gelatin, poly glycolic acid, poly lactic acid) to mimic the dermal layer of skin. FibroGen's recombinant human collagen type I has been shown to effectively construct the dermal layer of skin using protocols established for bovine skin or rat-tail type I collagens, the tissue-derived collagens typically used for skin substitutes. Using FibroGen's recombinant human collagen in skin substitutes could provide a more biocompatible material, reducing the risk of graft rejection.

Collagen Stents and Vascular Graft Coatings
Expandable, intra-arterial stents are widely used for treating coronary artery diseases. In addition to mechanical dilation, biopolymer-coated stents may provide supplementary functions such as local drug delivery, gene transfer, reduction of operative blood loss, and facilitation of endothelial cell in-growth. In a series of studies, FibroGen has demonstrated that knitted DACRON® vascular grafts coated with recombinant human type III collagen provide a suitable substrate for cell attachment and spreading.

Tissue Engineering
Tissue engineering is an emerging field that addresses a large medical need to routinely repair or replace failing or aging body parts. Commercial applications of tissue engineering already exist, for example, in the field of dentistry. For treatment of periodontal disease, such as gingivitis or periodontitis, open debridement procedures are used, which result in the migration of epithelial tissue into the affected area. This can prevent the restoration of periodontal ligament and bone. Collagen membranes and titanium films have been placed in the periodontal pocket as barriers that prevent gingival tissues from coming in contact with the root surface, allowing cells from the ligament and bone to repopulate the denuded root surface and recreate periodontal attachment. FibroGen has developed a prototype process to formulate collagen membranes using recombinant human collagen type I oligomers. Compared to commercial collagen membranes used in dentistry, FibroGen's recombinant human collagen type I membrane is less porous and more resistant to bacterial collagenase, attributes which could provide better regenerative results in a clinical setting.

Cell Attachment
Coating a surface with collagen can enhance cell attachment to that surface. Through experiments carried out by FibroGen and multiple collaborators, FibroGen's recombinant human collagens (types I and III) have been proven to perform as a potent substrate for cell attachment of various cell types. Thus, FibroGen's recombinant human collagens are appropriate for use in applications where enhanced cell attachment is desired.