Medical Devices

LEUKOCARE’s proprietary SPS technology enables next generation’s biologically functionalized medical devices.

The well-established concept of small molecule drug releasing devices is currently being adapted to protein or RNA/DNA coated devices or to devices employing progenitor cells in various therapeutic areas. Dental and orthopedic implants, stents and balloons, wound dressings and catheters are typical examples of such devices. Antibodies attracting distinct cell types, growth factors facilitating bio integration, antibiotics preventing biofilm formation or infection are examples of active ingredients of interest.

Key bottlenecks in the development and commercialization of such combination devices, the stability of surface coupled biological components (frequently stored in absence of water) and the sterility / quality of the finished product, are addressed by LEUKOCARE’s SPS technology. By protecting surface coupled biologics with a physiological and reversible small molecule coat, biological macromolecules are stabilized and protected against chemical and physical stress including irradiation for sterilization.

LEUKOCARE’s Stabilizing and Protecting Solutions (SPS) consist of physiological, non-toxic small molecule ingredients generally recognized as safe (GRAS status), which are individually customized to the specific needs of each substrate or product. SPS is sugar and protein free.

Due to the often complex manufacturing protocols, assuring sterility of biologic-device combinations is a significant challenge and economic burden. Enabling terminal sterilization has a potential for cost reduction at least by a factor 3 – 4 and significantly increases product safety.

LEUKOCARE has successfully designed, developed and clinically tested a biologic-combination device with therapeutic impact on the immune system (LIM).

LEUKOCARE offers services to medical device companies with respect to:

  • Product planning and design by identifying suitable pathways and effector molecules
  • Prototyping and product development work by exploring coupling technologies and formulation as well as stabilization aspects.
  • Analytics by establishing and validating biological, biochemical or biophysical readouts
  • Preclinical research by providing data concerning activity, stability and cytotoxicity.
  • Clinical research and registration by advising on regulatory aspects