When Julian Hergenröther of Leukocare (Martinsried, Germany) and I met years ago working student jobs before joining the real world, neither of us knew that we would bump into each other again several years later. But there he is—a biotechnical engineer writing an article about the latest technologies involving the biofunctionalisation and terminal sterilisation of medical devices for me. Well, for EMDT and the German-language supplement MEDTEC Magazin, that is. And guess how we got in touch again—facebook. It’s all about networking, so don’t underestimate social networks! But that’s another story.
Hergenröther writes in his article that the growing market for biologics demands new technologies concerning the production of biofunctionalised coatings in the medtech arena. In his article, he talks about the technologies that his company Leukocare developed. The technologies are called Stabilizing and Protecting Solutions (SPS) and enable the stabilisation of proteins during production, sterilisation by irradiation and storage.
Hergenröther stresses that therapeutic proteins are becoming increasingly important in the development of medical devices. As an example he cites a new class of device: biofunctionalised stents with antibodies coupled to the surface. Other examples of new biologic-device combination products include wound dressings and orthopaedic implants functionalised with growth factors that stimulate, respectively, wound healing processes and the attachment of new bone material. “The challenge of handling therapeutic proteins lies in their sensitivity to physical stress, which poses significant constraints to production and sterilisation procedures,” Hergenröther says.
He explains that liquid protein formulations in a biopharmaceutical context are typically sterilised by filtration. But filtration is not applicable to proteins attached to surfaces. Heat also is typically inapplicable since proteins tend to be rather heat sensitive. Exposure to gamma or beta irradiation is frequently used in the sterilisation of medical devices but so far it has been impossible to maintain the proteins’ functionality following standard doses of irradiation applied during sterilisation, according to Hergenröther.
Leukocare AG has developed technologies that enable the stabilisation of proteins during production, sterilisation by irradiation and storage. The so-called Stabilizing and Protecting Solutions (SPS) are biocompatible and easy to handle, Hergenröther says. “They do not require major adjustments in the production process. The SPS solutions are customisable and can be adjusted to customer requirements and the demands of a given application.” In addition to functionalised medical devices, SPS technologies also can be used in the fields of biopharmaceuticals, vaccines and diagnostics.
“The mechanism by which proteins are stabilised by SPS is comparable to the glaze on top of a fruit tart,” Hergenröther explains. “Picture a strawberry pie without the glaze—it would turn brown after a few hours. The glaze preserves the look and taste. Similarly, SPS forms a thin protective amorphous coat around the proteins during drying. It increases the stability of the proteins during storage and protects the three-dimensional structure during sterilisation using gamma, beta radiation or ethylene oxide gas,” says Hergenröther.
And to demonstrate how SPS technology works, the company offers a real fruit flan when exhibiting at trade shows. Now that’s what I call food for thought!
You can read the full article, titled “Innovative Technologies for the Biofunctionalisation and Terminal Sterilisation of Medical Devices” on emdt.co.uk.Yvonne Klöpping