Compass Biotechnologies is acquiring a worldwide exclusive license to U.K. firm Arecor’s drug stabilization technology Arestat™, initially for the development of a heat stable hepatitis B vaccine that can be stored at room temperature. The vaccine will be developed by Compass’ C-Pharma subsidiary, which is focused on developing hepatitis products. The firm will in addition look at the potential for developing heat stable formulations of other products.
Compass says studies with the Arestat-formulated hepatitis B vaccine have demonstrated that the product retains greater than 70% potency when stored at 37oC, and is just as effective after 12 months of storage at 37oC as after storage at refrigeration temperatures. In contrast, the firm notes, a commercially available heptatitis B vaccine lost its effectiveness completely and demonstrated a 100-fold drop in antihepatitis B titer when stored at 37oC.
Arestat is essentially a set of formulation tools to address the principal pathways of degradation that lead to the loss of drug structural integrity and biological activity, Arecor explains. The three resulting technologies utilize FDA- and EMEA-approved buffers and excipients to achieve the desired stability. Arestat-T™ has been developed to stabilize biologics during storage at refrigerated, ambient ,or elevated temperatures. Arestat-C™ allows the stabilization of proteins, particularly antibodies, at high concentrations. Arestat-R™ is used to stabilize biologics exposed to ionizing radiation (e.g., gamma radiation). Arestat can be readily incorporated into standard manufacturing practice, without covalent modification of the biological, using excipients approved for the route of delivery, Arecor adds.