Today, nearly 97% of biopharmaceutical manufacturers use single-use technologies. Not only are manufactures implementing single-use technologies, but also the range of applications for which these technologies are being used is expanding. Recent innovations have made a wider range of single-use technologies available for most downstream purification applications and production scales. Disposable systems for bioprocessing have come a long way over the last few years – indeed integration of these systems within manufacturing plants has become quite a talking point in the industry. Companies have come to recognise the significant benefits of disposables – no cleaning and cleaning validation, faster turnaround, shorter time to market, reductions in both capital & operating costs.
The aim of the Disposable conference at BioProduction is to answer many questions with regards to implementation of this technology. Learn from industry experts and end-users who will share their experience.
Are you using disposables in your manufacturing site and if so what problems if any have you encountered?
Louisa Maitland (Please note new married name)
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Whilst researching into the current Antibody Production and Downstream Processing 2008 programme I spoke to several people in the Industry. The main challenge that was mentioned is the on-going issue with improving DSP (downstream processing) to fit the increasing USP-product titres. People are keen to know what is being done and who is looking at trends and new methods to solve this issue. What are the latest chromatography methods and column material being used? What options are available for the design of different materials? Are you replacing Protein A or abandoning it all together? The upstream-downstream gap is widening at an alarming rate. New technologies will have to be found and some old technologies will have to be reinvented. To meet the demands a comprehensive strategy is needed for process development. The bioprocessing industry has worked its way into a corner that seems to vindicate the adage, “be careful what you wish for, because you might get it.” As fields of protein per litre of cells spiral through the roof, there appear to be little way that the purification end of bioprocessing can keep in a cost-effective manner. Indeed the per kilogram cost of protein A now runs into millions of dollars.
What are your views and how is your company tackling this ever increasing problem?
Well next week is a short week for me; I’m getting married on Friday so you’ll soon see a change in my surname from
Pickering to Maitland. I’ll write again in a few weeks when I’m back from my surprise honeymoon.
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