The Medical Technology Blog

In the spirit of open innovation, DSM Biomedical, a developer of medical biomaterials, has been actively exploring licensing opportunities for its products, as well as partnering with medical developers to aid growth and product development. To pursue this, in 2010 alone, the company has entered into six long-term licensing agreements with global medical device manufacturers in the fields of orthopaedics, cardiovascular, vascular and urology. Having also signed nine new licence agreements in 2009, DSM is continuing its trend of partnering with medical device companies to develop new products that incorporate novel materials and technologies.
The six new agreements allow DSM to work in conjunction with medical device manufacturers throughout various phases of development, prototyping, manufacturing and processing of product commercialisation to collectively create new products that serve the medical community and their patients. Specifically, these medical device companies will be in a position to apply the track record of DSM’s advanced biomedical materials, including Bionate PCU, CarboSil TSPCU and ComfortCoat medical coatings in applications such as total disc replacement, spinal stabilisation, continuous glucose monitoring, cardiac rhythm management, neurostimulation, catheters and heart assist devices.

In one such case, DSM recently partnered with PolyTherics, an innovator in precision engineering of proteins, to develop and manufacture the latter’s lead biobetter product, HiPEG IFN alpha-2a. PolyTherics’ site-specific PEGylation technology has been applied to interferon alpha to produce HiPEGIFN alpha-2a, which has eight-fold higher activity than a marketed PEGylated interferon in vitro, and a comparable half-life in a preclinical study.  HiPEG specifically attaches poly(ethylene) glycol (PEG) to a histidine tag at the end of the protein; histidine tags are commonly used to improve protein stability and to facilitate the purification of proteins.

DSM has started development, scale-up and manufacture of the recombinant his-tagged IFN alpha-2a, and PolyTherics will transfer its HiPEG PEGylation method to DSM so that the process can also be scaled-up. The companies intend to develop a robust process to produce sufficient material for preclinical development and then for cGMP production of HiPEGIFN alpha-2a for clinical development.

In addition to this, DSM has extended its partnership with Spinelab, a privately-held company developing a dynamic stabilisation system for the spine. Spinelab’s Elaspine implant system, a pedicle screw-based posterior motion preservation system for the degenerative lumbar spine, uses Bionate PCU, DSM’s polymer with optional built-in surface modification, which is designed for chronic implants and extensively used in orthopaedic applications for its load-bearing qualities. The implant system also marks the first clinical use of a PCU-only posterior rod.

With the use of this technology, the viscoelastic material properties of the polymer rod allows the system to act comparably with a damper thus enhancing stability and reducing the effects of peak loads. Bionate PCU has been a key material used by Spinelab in its core product Elaspine, which is designed to reduce pain for patients while still allowing limited range of motion in the spinal column. Introduced in 2009, Elaspine has most recently completed a one-year performance assessment review involving its first patients.

Through these partnerships, DSM hopes to build on the expertise gained in its 2008 acquisition of The Polymer Technology Group (now known as DSM PTG), and further the use of its product portfolio. Key products include the Bionate PCU and CarboSil TSPCU biomedical polymers, which are said to have “excellent” biostability, high strength and abrasion resistance, making them candidate materials for load-bearing orthopaedic implants.

Thanks to Sophie Bracken for this post, Sophie is the Editor of Orthopaedic Business at Espicom Business Intelligence



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