Scaling the Bioprocess Barricade
Just over a week ago, I decided to hop on the early train to Glasgow, Scotland, so that I might catch at least half of the 8th bioProcess UK conference, focusing on advancing next generation therapies. The meeting was held in the very fitting Glasgow Science Center and, given the strikes over public sector pensions that day, there were plenty of youngsters mingling with the crowds—the next generation of bioprocess engineers perhaps? Amazingly, presentations were delivered in the IMAX theatre—I have never seen PowerPoint slides on such a scale before—but given the eminence of some of the keynote speakers involved, it too was quite apt.
Aside from the keynote speakers, there was also a poster session bringing together some 30 sets of research from British universities. Topics ran from small-scale chromatography resin development for the purification of Japanese encephalitis virus to a biotechnology-based platform to optimise the expression of monoclonal antibody (MAb) sequence variants in CHO cells. University College London was extremely well represented, contributing almost a third of all posters. There was a competition for best poster and the winner was Rhian Grainger from the University of Sheffield with the title “Cell line specific control of recombinant antibody N-glycosylation.”
Howard Levine, president of BioProcess Technology Consultants, discussed the changing landscape of mammalian cell culture manufacturing capability and presented some very interesting data. He noted that MAbs are driving biopharmaceutical revenue and predicted that commercial antibody demand could double by 2016. But what about manufacturing capacity to cope with increasing biopharm demand? The main take away point was that while utilisation currently stands at 43%, this figure is expected to increase to 64% in five years and because much of the capacity (around 75%) is controlled by only 10 companies, access to manufacturing could become difficult. Are CMOs readying themselves?
Research Centre Jülich’s Peter Rohe stepped up the technical detail with his research into boosting bioprocess optimisation through the use of an automated micro-titer plate cultivation system. The system aims to hit the middle ground between controlled conditions and high throughput.
Aidan Courtney from Roslin Cells gave a thought provoking talk on scaling up cell manufacture from the point of view of translating research protocols into GMP processes. He noted that “the destination defines the journey” meaning that, depending on the application of a particular cell therapy, the quantity of cells required for treatment becomes a crucial parameter. Courtney went on to provide numbers for a couple of example scale-up scenarios; ischemia therapy would probably require 100000000 cells per treatment, so estimating perhaps 10,000 treatments per year, the numbers start multiplying faster than the cells… He concluded that GMP translation and scale-up are challenges best addressed in tandem.
There were several more presentations during the first day including an introduction to the “Kymouse” from Kymab’s Tom Shepherd. Watch this space. The final lecture was given by this year’s recipient of the Peter Dunnill Award, Professor Mike Hoare from University College London. It was an inspiring presentation and almost a supplication for companies, funding organisations and academic institutions to continue working together to facilitate breakthroughs in bioprocessing. Focusing on ultra scale-down for enhanced bioprocess discovery, Hoare concluded “Design for manufacture; design for lower cost.”
Regrettably, I couldn’t make the second day of the conference, but I hope that PharmTech will be able to deliver some of that content through contributions from some of the speakers in 2012. You can find more information about BioProcess UK conference here.
Much of the information presented in my BioProcessUK talk was drawn from BioProcess Technology Consultants’ new report “The State of Mammalian Cell Culture Biomanufacturing.” This newly published report offers an in-depth review of the growth in sales and production demand for biopharmaceutical products currently on the market and in development. The report also provides a comprehensive analysis of the current and future supply and demand for mammalian cell culture capacity, including the geographic distribution of manufacturing capacity, the impact of facility utilization rates on overall capacity requirements, and the influence of emerging technologies on manufacturing facility design and utilization. For more information, see http://www.bptc.com/reports.php.