As part of the VISION programme offered by UCL Biochemical Engineering, the EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies sponsored a workshop held on 4th November 2014 at UCL to explore the supply chain challenges facing companies developing biopharmaceuticals and advanced medicinal therapy products (ATMPs). Here Suzy Farid and Andrew Davidson from the EPSRC Centre offer some initial reflections on a few of the key messages.

The workshop opened with two presentations, the first from James Christie (Oxford Biomedica) looking at the supply chain issues for gene therapy and the second from Linda Randall (Actavis) focused on biopharmaceuticals. Our two speakers were joined by Scott Lawson (PwC) and Kevin Smith (Trakcel) to form a panel for an open forum Q&A session following the talks.

James Christie

James Christie

ATMPs are commercially at an earlier stage of development than biopharmaceuticals and the supply chains are only just being put together. To achieve what James calls “orchestration” i.e. providing certainty that the patient’s treatment is from their own cellular starting material and ensuring the time-critical steps and temperature requirements of the supply chain are being managed, sophisticated track and trace tools are required. These would appear to be more advanced than anything currently deployed in biopharmaceuticals or even pharmaceuticals more generally. Kevin Smith whose company supplies such tools for ATMPs sees the supply chain as circular rather than linear with the patient/donor at its centre. This “patient-centric model” is a powerful concept and has resonance across all the players involved in gene therapy and ATMPs as they strive to achieve early success and patient safety with their new therapies.

Linda Randall reported on a project at Actavis to improve its supply chain which involves extensive application of single use technologies. Like James she also highlighted the importance of early engagement with suppliers and trust. The company uses a structured and cross functional approach to engage with suppliers and to ensure that decisions are not solely technical driven. It has also worked hard to reduce the number of suppliers to simplify the supply chain and to ensure dual sourcing as far as possible. Nevertheless a surprising number of items remain single sourced and these relationships can be very critical. Trust can be a rather elusive concept and Linda’s talk revealed the time and effort required to develop trust in such supplier customer relationships.

The question of what we can learn from other sectors is always interesting and this was one of the topics in the discussion session. Scott Lawson thought there was much that could be learnt and pointed to the progress the food industry has made to track and trace meat supply back to individual animals on named farms. Much closer to the focus of this meeting and often overlooked, Damian Grantham from the Cell Therapy Catapult observed that the National Blood Transfusion Service already addresses some of the issue facing ATMPs including the use of bar coding of supplies and managing the logistics of handling blood products requiring controlled temperature storage and distribution.

VISION_audienceAndy Brown from Actavis pointed to the collaborations that were evident in other supply chains such as automotive and electronics and wondered whether a more collaborative approach could be developed for biopharmaceuticals and ATMPs. The consensus appeared to be that issues involved in developing good supply chains for biopharmaceuticals and ATMPs were not really different from those faced in say aerospace or the automotive industry.

There are distinguishing characteristics, however, and Kevin provided a rich picture of an expensive ($50,000 plus) asset to be tracked through to patient infusion, managing temperature and time risk, available manufacturing capacity to schedule, and customs challenges – amongst others.

A full report on the meeting is being prepared and will be available from the EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies website.