Feasibility study for the scale-up and automation of the Biopatch manufacturing chain

PI: Pierre-Alexis Mouthuy

Department: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)

Shoulder muscles and tendons allow us to move our arms, carry out daily activities, work and play sport. Pain and loss of function arising from disease or injury of the tendons can cause significant long-term disability. Shoulder pain is the third commonest orthopaedic problem to present to General Practitioners. Moreover, it is a growing social and economic burden as our population is aging. Currently 17,000 patients annually in the UK have torn tendons that require surgical repair and this number is increasing. Unfortunately around 40% of these surgical repairs fail to heal, meaning that new strategies are needed to improve patient outcomes.

We have recently developed a synthetic degradable patch, BioPatch, which mimics a normal tendon and is capable of promoting much better healing. BioPatch has shown very encouraging results both in vitro and in vivo, in small and large animal models. It is now in preparation for a first-in-man clinical trial, scheduled to start in 2019. As BioPatch is made of polymers already used in clinics and given our positive pre-clinical results, we do not anticipate any safety issues in the trials. One of the main challenges ahead of us is the need for a significant scale up of the manufacturing process. While our current manufacturing chain is able to produce a sufficient number of patches for the clinical trial, it would be unsuitable for their commercialisation. The aim of this project is therefore to investigate the feasibility of scaling up our capability to produce BioPatch to a level suitable for initial commercialisation. To achieve this, and to ensure that the best strategy is selected, we will work with a design and automation company, GB Innomech. At the end of this project, we will be in a stronger position to attract investment for its implementation prior to commercialisation. This work will also benefit patients indirectly, as it will accelerate the translation of a promising medical device to the clinics.