- SPS® improve medical devices which employ proteins and peptides to create biological functionality
- SPS® technologies meet the requirement for terminal sterilization in the medical device industry
LEUKOCARE’s SPS® technologies enable biologically functionalized medical devices and pave the way for terminal sterilization
Key bottlenecks in the development and commercialization of biologic-device combination products:
- Stability of the surface-coupled biological components
- The opportunity for terminal sterilization
- Extended shelf life with maintained quality and functionality of the protein
All these issues are addressed by our SPS® technologies: the coated biologics are reversibly covered by SPS®, thus stabilized and protected from chemical and physical stress during manufacturing, sterilization (β- and γ-irradiation or ethylene oxide) and storage.
SPS® enable the development of a broad range of biofunctionalized surfaces. Examples of medical devices to benefit from the SPS® technologies are:
- Wound dressings & patches
- Extracorporeal blood treatment devices, apheresis columns
- Implants (orthopedic and dental) & bone cements
- Catheters, balloons and stents
Customized biofunctional surface proteins and peptides can be coupled to carrier surfaces with the help of different coupling technologies.
The functional proteins can be bound covalently or non-covalently to the surface. Specific elution kinetics can be applied.
In a final step prior to sterilization, the functional proteins – for example an IgG antibody as shown in the figure - are coated with a selected and optimized SPS® formulation.
SPS® protection allows for terminal sterilization, long term storage and preserves functionality of applied biologics.
LEUKOCARE has successfully designed, developed and clinically tested an SPS® protected biologic-device combination product to prevent an overreaction of the immune system during extracorporeal treatments, the Leukocyte Inhibition Module (LIM).