While the initial focus at bioProcessUK was on recombinant proteins, there is a growing interest in vaccines and regenerative medicine, according to Malcolm Rhodes, Ph.D., technical director. It is also becoming clear that cell-based therapies will play a major part in the U.K.’s biotech pipeline in the future. “There is huge potential to reduce the cost and improve the availability of cell therapies through better product design and more efficient supply chains,” he said.

The group aims to promote a broad vision of the sector through the exchange of knowledge between academia, regenerative medicine companies, biotech companies, suppliers, and regulators.


The Advanced Therapies Group covers cell therapy, tissue engineering, and, perhaps in the future, gene therapy, and has links to other existing networks such as SSCN, the Institute of Chemical Engineers, and Remedi (an engineering and physics science research council regenerative medicine program in the U.K.).



The group aims to promote a broad vision of the sector through the exchange of knowledge between academia, regenerative medicine companies, biotech companies, suppliers, and regulators.
Packaging of a cell-therapy product must also be able to cope with the range of production—from small scale to bulk orders—and take into account that even something as simple as orientation of the product within the packaging could be crucial.
Companies developing and manufacturing an advanced therapy also need to deal with an emerging regulatory regime. Duncan Mackay, director of regulatory affairs at Genzyme, explained that “the absence of a regulatory framework hinders the development of the cell-therapy sector.” He added that it should always be remembered that “the priority of the regulators is to protect the patient,” so the level of regulation should be proportional to risk. Companies, therefore, need to have a risk-management plan in place.

One question the regulators are interested in, especially the FDA, is how you characterize your product. In other words, do you know what you are putting into patients?” Mackay said. There is also concern over what effect transportation systems have on cells, and whether dead cells should be treated as contaminants and the impact of cell lysates. (Put simply, should patients be loaded with dead cells?).



“It is fundamental to characterize your product, and at an early stage,” Mackay added.

bioProcessUK intends to continue to foster dialogue regarding best practices in advanced therapies. Future topics to focus on could include scale-up versus scale-out in manufacturing, discussions with regulators, and the development of an attractive business model for these products to make them attractive to investors.