Engineering biological solutions for next generation drug therapies

The next decade will see biologically derived therapies dominate the treatment landscape, according to Professor Nigel Titchener-Hooker during his delivery of the 27th Danckwerts Memorial Lecture in Atlanta, US on 17 November.

Professor Titchener-Hooker, head of department of biochemical engineering at University College London (UCL) and director of EPSRC Centre for Innovative Manufacturing of Emerging Macromolecular Therapies, also argued that current limitations in downstream processing techniques threaten to obstruct progress and that earlier consideration to bioprocess challenges should be given during drug development.

In 2013, eight of the top ten selling drugs worldwide were ‘biologics’ products manufactured in a living system such as a microorganism, plant or animal cell. Most biologics, including the top sellers, Humira®, Enbrel® and Remicade® are very large, complex molecules produced using recombinant DNA technology.

“Companies still tend to progress on the basis of clinical promise,’ said Titchener-Hooker. “They tend to think about ease of manufacture much later, and vital process decisions are all too often isolated from business decisions, with unhelpful consequences.”

“Biochemical engineering offers the tools and methods to enable more rapid transition from clinical promise to manufacturing certainty,” he continued. “This will enable better business decision making by leveraging a fundamental understanding of ways to improve purification processes quickly, and with confidence. This will deliver affordable, next generation therapies.”

Titchener-Hooker drew on examples of his work on process miniaturisation at UCL, which he described as “ultra scale down”. Case studies of the bioprocess optimisation of operations, including centrifugation and chromatography, were discussed in the context of the latest computational techniques and decision making tools. The lecture made a compelling case for process optimisation and cost reduction via better equipment sizing in multi product facilities.

Danckwerts’ memory was invoked several times during the lecture: “It has been shown that we can make billion dollar drugs. But can we make drugs for billions of patients?” Titchener-Hooker asked. “I believe we can; but this will demand exceptional levels of collaboration between academics and industry backed by supportive funding agencies.

“Danckwerts was a firm advocate of informed and relevant education. His thinking remains relevant to this day and it has been a great privilege to deliver the lecture that bears his name.”

IChemE director of policy, Andy Furlong, said: “Peter Danckwerts' thinking revolutionised chemical engineering. He helped to shape the discipline as we know it today.  His papers on boundary conditions are beautifully written and continue to inspire successive generations of postgraduates.  Nigel's work on downstream bioprocessing draws on the legacy of Danckwerts and he was an excellent choice for this year's lecture.”

The Danckwerts Memorial Lecture, which takes place annually, is co-sponsored the Institution of Chemical Engineers (IChemE), the European Federation of Chemical Engineering (EFCE),  and the American Institute of Chemical Engineers (AIChE),  and is supported financially by Elsevier and published in their journal Chemical Engineering Science.

The 28th Danckwerts Lecture will be delivered at the tenth European Congress of Chemical Engineering (ECCE 10), which takes place in Nice, France, from 27 September – 1 October 2015.