Sand Pit - New Industrial Systems: Optimising Me Manufacturing Systems

The Optimising Me Manufacturing System [OMMS] project is developing a healthcare microfactory that provides on-the-body manufacturing of therapeutics. The concept arose during the EPSRCs New Industrial Systems workshop held in May 2017, bringing together researchers from a diverse range of disciplines to work together to create transformative impact on our manufacturing industries. The initial proof-of-concept focuses on the development of a manufacturing system for T-cell immunotherapies, located on the body and delivered on demand in response to the patient's needs. The long-term vision the creation of modular microfactories, built using a range of underlying common technologies, enabling future on-body manufacturing of a range of different therapeutics.

total awarded amount £1800000

OMMS goes beyond the current state of the art and re-defines healthcare manufacturing. It offers a step change in current manufacturing trajectories, enabling responsive delivery of bespoke therapeutics as part of a distributed manufacturing system. T-cell delivery was chosen chosen specifically because of its demonstrable therapeutic capability. In September 2017, they will become the first gene therapy to have been approved by the US FDA. From the clinical data presented thus far it appears these genetically modified T-cells present a CURE for some of the most aggressive forms of cancer (Acute Lymphoblastic Leukaemia, Chronic Lymphoblastic Leukaemia). The current manufacture of T-cells is undertaken in a laboratory and can take up to 21 days, depending on the quality of the patient's starting cellular material. The long, complex and expensive process poses the risk of contamination and further complications due to patient variations. The development of a continuous manufacturing capability will address some of these shortcomings and would allow the continuous manufacture and delivery of the therapy to the patient. Moving therapeutic manufacturing away from the current one-size-fits-all approach could enable advances which deliver patient-specific therapies of sufficient precision and quality for personalised medicine.

By creating a proof-of-concept platform within a very short timeline, OMMS will demonstrate distributed therapeutic manufacture on/at-patient, with clear scope for extension towards other pharmaceutical manufacturing targets e.g. diabetes monitoring and control. The project takes steps towards de-risking the development of key technologies in on-body integration, manufacturing process and biometrology (measurement of the product throughout the microfactory to ensure that strict quality and regulatory requirements are met). The development of technologies that are transferable to a number of future healthcare manufacturing systems will pave the way for the broader uptake of the microfactory platform concept.

The project has three main over-arching objectives:
1. Proof-of-concept for a new microfactory platform for therapeutic manufacturing, moving pharmaceutical manufacturing from a non-responsive, centralized process towards a bespoke, distributed manufacturing process.
2. Direct engagement with industrialists, academics and policy makers towards this new vision of therapeutic and healthcare manufacturing in the U.K.
3. Delivery of a prototype of the microfactory platform, based on T-cell immunotherapy, incorporating 4 main elements into the factory on-body:
a. Specific cell isolation directly from the patient's blood.
b. Processing of these raw materials towards a deliverable therapeutic.
c. Complete integration of biometrology, to ensure quality control, from isolation through the microfactory process.
d. Fully integrated feedback between the location, biometrology and manufacturing process phases of the microfactory, responding dynamically to demand and quality parameters.