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Scil Technology develops regenerative products for orthopaedic and dental applications by using synthetic biomaterials to deliver pharmaceutically active proteins or peptides to induce local tissue regeneration. The Company applies its proprietary technology and utilizes interdisciplinary approach for its product development. The product candidates are coated ceramics, metals, organic and inorganic polymers; each contains a specific growth factor that is designed to be released from the biomaterial in a controlled manner over time.
Three different growth factors which have been validated in cartilage and bone regeneration are incorporated in Scil’s products. These growth factors are highly specific human recombinant proteins. The growth stimulating properties of such proteins are optimized to create novel products facilitating normal healing and function of tissues.
The biomaterials used in these products are designed to be biodegradable, biocompatible and completely resorbable in vivo. These features enable the biomaterial to degrade at the same rate as new tissue is being generated.
Aside from developing product candidates, the Company is also developing industrial manufacturing processes for its product candidates. For a number of products, these processes are ready for implementation in the industrial scale GMP manufacturing environment.
In brief, Scil Technology covers the entire development chain from laboratory, preclinical and clinical development to produce cutting edge products serving the field of tissue regeneration through its experience and expertise in Pharmaceutical Development, Technology, and Quality as well as Regulatory Affairs.
Growth factors used in Scil’s dental and orthopaedic
applications
rhGDF-5
rhGDF-5 is the recombinant form of the human Growth and Differentiation Factor 5, a member of the bone morphogenic protein (BMP) family. It promotes the growth of bone and is considered as one of the most potent bone growth factors currently available. It has comparable bone growth-stimulating features to the growth factor BMP-2 [1], currently on the market for orthopaedic and maxillofacial applications. rhGDF-5 has a favourable safety profile compared to other BMPs and has shown convincing results for controlled bone formation while avoiding excessive bone growth associated with BMP-2.
A patent portfolio on the growth factor rhGDF-5 was licensed from Biopharm GmbH, Heidelberg, Germany, granting Scil Technology the worldwide exclusive rights to develop, manufacture and commercialise products containing rhGDF-5 for dental and maxillofacial applications.
rhBMP variant
Scil Technology uses a recombinant human bone morphogenetic protein variant for orthopaedic applications. This growth factor, derived from E. coli, is used for effective bone augmentation and has strong osteoinductive properties.
rhCD-RAP
The growth factor rhCD-RAP represents a substantially novel molecule for cartilage regeneration. It is highly specific for cartilage tissue and has been shown to play a crucial role during cartilage formation in embryonic development and in adult animals. Moreover, rhCD-RAP stimulates the synthesis of cartilage matrix as demonstrated with cartilage cells from osteoarthritis patients [2] [3] [4] . These properties make rhCD-RAP a highly promising candidate for cartilage regeneration.
Scil Technology owns the worldwide patents concerning the substance and production of rhCD-RAP, the medical use of rhCD-RAP for cartilage repair and the use of rhCD-RAP as diagnostic tool for cartilage diseases. A License Agreement has recently been concluded with Pfizer Inc., where Pfizer will be responsible for all further development of rhCD-RAP.
[1] US markets for dental bone graft substitutes 2003, Millenium Research Group, 2003
[2] Dietz, U. et.al, 1996, J. Biol. Chem.271:331-3316
[3] Xie, W.F. et. al, 1998, J. Biol. Chem. 273:5026-5032
[4] Tscheudschilsuren, G., 2004, J. Cell. Physiol., submitted
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