Recombinant Human Collagen
Collagen has Many Applications in the Medical Device and Pharmaceutical Industries
Collagen, a major component of the extracellular matrix, is a fibrous protein that provides tensile strength to tissues. Medically, collagen has been widely used in such diverse applications as dermal augmentation, wound repair/surgical hemostasis, drug delivery, tissue engineering, and as coatings to increase the biocompatibility of many medical devices.
Advantages of FibroGen Recombinant Human (rh) Collagens
FibroGen's Multigene Expression System enables formation of thermally stable, triple helical collagen through coordinate expression of genes encoding collagen and encoding prolyl 4-hydroxylase.
FibroGen's recombinant human (rh) collagens offer superior, highly purified, fully characterized, biocompatible alternatives to animal-derived collagen for use in all applications in which collagen is used today. FibroGen uses proprietary recombinant methodology1 in a yeast expression system with human DNA sequences to develop synthetic versions of human collagens essentially identical to the native protein. While mixtures of various collagen types found in animal remains may be undesired and nearly impossible to segregate, FibroGen can produce specific types of rh collagen (e.g., types I or III) consistently and reproducibly. FibroGen has developed simple, scalable purification processes that provide highly purified and reproducible lots of protein in any desired quantity, and employs a series of rigorous analytical tests to ensure lot-to-lot consistency and high quality.
Development Opportunities: FG-5016 (rhCIII)
FibroGen has developed several prototype products and conducted proof of concept studies demonstrating the application of FibroGen rh collagens (types I and III) in a broad range of formats.2-4 FG-5016 was found well tolerated in a human safety study designed to demonstrate the suitability, tolerability and safety of FG-5016 when administered intradermally in multiple injections. Research-grade material is available for purchase (please visit our Reagent Store). For more information or a data package on FG-5016, please contact our Business Development group at FibroGen: bd@fibrogen.com or (415) 978-1280.
Proof of concept: biosynthetic cornea
Since 2005, FibroGen has collaborated with Dr. May Griffith of Linköping University to develop biosynthetic corneas molded from chemically cross-linked rhCIII. The biosynthetic implants are designed to mimic the human cornea, which is composed mainly of collagen. In a phase 1 clinical study, 10 patients with corneal disease underwent resection, followed by surgical implantation with rhCIII-based biosynthetic corneas. Two-year post-surgery results demonstrated that 100% of the transplanted corneas remain viable at two years, cells from the patients’ own corneas had grown into the implant, and nerves that had been severed during surgery regrew. In addition, the blink reflex and tear film were restored. In terms of visual acuity, at 24 months, best spectacle-corrected visual acuity improved in six patients, remained unchanged in two patients and decreased in two. None of the patients experienced any rejection reaction or required long-term immunosuppressive therapy, serious issues associated with the use of human donor tissue.5 Read more
Dermal Filler Development Program: FG-5030 (rhCIII, cross-linked formulation)
FibroGen is advancing the development of FG-5030, a cosmetic dermal filler formulated with highly crossed-linked rhCIII. Read more
References
1. Baez, J. et al. Recombinant microbial systems for the production of human collagen and gelatin. App Microbiol Biotechnology (2005) 69:245-252.
2. Yamada, K. et al. Fabrication of cultured oral gingiva by tissue engineering techniques without materials of animal origin. J Periodontol (2006) April;77 (4) 672-676.
3. Liu, Y. et al. Properties of porcine and recombinant human collagen matrices for optically clear tissue engineering applications (2006) Biomacromolecules 7:1819-1828.
4. Liu, W. et al. Recombinant human collagen for tissue engineered corneal substitutes. (2008) Biomaterials 29:1147-1158.3. Liu, Y. et al. Properties of porcine and recombinant human collagen matrices for optically clear tissue engineering applications (2006) Biomacromolecules 7:1819-1828.
5. Fagerholm P, et al., A Biosynthetic Alternative to Human Donor Tissue for Inducing Corneal Regeneration: 24-Month Follow-up of a Phase 1 Clinical Study. Science Translational Medicine Volume 2 (25 August 2010).
