Transcript for Manufacturing the Future Conference 2015 - Interview with Professor Nick Medcalf

My name is Nick Medcalf.  I’m Professor of Regenerative Medicine Manufacture at Loughborough University.  I’m there under an EPSRC Manufacturing Fellowship, having come in from industry after more than 30 years in the business sector. My job is two-fold, one is to manage the Centre for Innovative Manufacturing in Regenerative Medicine and the other is to conduct a portfolio of research as an industrial fellow.

Regenerative medicine is a group of treatments which have one thing in common - they tend to be biological therapies that restore function or replace missing organs or tissue, rather than simply acting in a palliative way to manage a condition in the way that we’re familiar with: for example on-going drug treatment or something like that. They tend to be treatments that are based on cells, tissue or gene therapies and they are, as a group, products that tend to restore patients to a condition that existed before the injury or disease took some function away.

The way that we work with the research is systems-based. These products are quite advanced and very few of them can be made and put on a shelf for months in the way that we’re familiar with, with, for example medical devices or most conventional drugs. In some cases, manufacturing is difficult to define where it begins and ends. Rather than a central factory, it might be appropriate to make the goods close to the patient’s bedside. Or, in some cases, involving the patient’s own metabolism as part of the work.

And so, alongside the fundamental research on how to make the goods, there are key issues about how to maintain quality when, for example, the therapy might be specific to individual patients. Alongside that as well, there’s a related issue, which is how to manage supply chains when the goods are exquisitely sensitive to changes in conditions and might be spoiled if they’re left too long in transit or subjected to temperature fluctuations.

So all these things that would traditionally be part of supply chain research, are now an integral part of the research into the manufacturing path.