Novel rhThrombin Provided in Innovative Stabilized Formulation

Scil Proteins GmbH and LEUKOCARE AG have announced results of their strategic partnership to develop a stabilized recombinant human thrombin (rhThrombin).

The new, proprietary and highly cost-effective bacterial manufacturing process of rhThrombin is a recent in-house development of Scil Proteins. This recombinant production process does not rely on bovine or human blood derivatives and can be scaled up easily to meet market demands.

Combining rhThrombin with a formulation of LEUKOCARE’s proprietary Stabilizing and Protecting Solutions (SPS) technology results in increased stability during storage at elevated temperatures as well as during terminal sterilization by irradiation. This offers various opportunities for novel formulations and advanced functionalized medical devices.

Controlling bleeding in surgery and avoiding blood loss during surgical intervention can be managed in several ways. One being the topical application of thrombin as a haemostatic agent.

Currently there are three types of thrombin available for use in humans: bovine thrombin, human purified thrombin and only one rhThrombin which is produced in chinese hamster ovary cells.

However, bovine thrombin holds the risk of anti-thrombin antibody production in patients. A main concern regarding the use of human purified thrombin is the risk of infectious agents like viruses and limited stability.

Recombinant products are usually free of infectious agents and impurities. Clinical studies with other available rhThrombin demonstrated comparable efficacy but significantly lower immunogenicity.

The substrate was safely applied in haemorrhage control in patients with or without pre-existing anti-bovine thrombin antibodies. Hence, products with rhThrombin may offer improved safety in clinical use.

The novel stabilized rhThrombin developed by Scil Proteins and LEUKOCARE may be used in different medical applications and medical devices to control bleeding for example sponges, glues, sealants or advanced wound dressings.

“We are able to provide access to high quality rhThrombin, free of blood derived components and with a fully scalable manufacturing process in bacteria” said Dr. Ulrike Fiedler, CEO of Scil Proteins.

Michael Scholl, CEO of LEUKOCARE added “As rhThrombin protected by our SPS technology is stable during irradiation it offers the opportunity for end sterilization as common in the medical device industry and as requested by regulatory agencies.”

Scil Proteins and LEUKOCARE are currently evaluating partners in the pharmaceutical and the medical device industry for the clinical development and commercialization of the stabilized rhThrombin.