A Route to Translate a Silk-Based Medical Device from Lab to Clinic: The Silk Biomaterials Srl Experience.

The medical device is a nerve conduit entirely made of silk fibroin. It is a tubular scaffold used for repairing peripheral nerve gaps, whose function is to protect the severed nerves and to favor their natural healing process. As any implantable medical device, the conduit must perform its function without causing adverse effects to the patient, meaning that it must be compliant with a range of regulations aimed at evaluating the risks related to the constituent materials and the manufacturing process, the toxicological impact of the processing aids, the biological safety, the functional performance, and the ability to sustain tissue regeneration processes.

An accelerated surface-mediated stress assay of antibody instability for developability studies.

High physical stability is required for the development of monoclonal antibodies (mAbs) into successful therapeutic products. Developability assays are used to predict physical stability issues such as high viscosity and poor conformational stability, but protein aggregation remains a challenging property to predict. Among different types of stresses, air-water and solid-liquid interfaces are well known to potentially trigger protein instability and induce aggregation.