One of the questions posed to our continuous processing panel at last week’s BDP Week in Huntington Beach, California was “What will it take for continuous processing to be adopted in GMP manufacturing processes?” The panel was comprised of scientists and engineers at the forefront of evaluating and implementing continuous processing in bioprocess applications (other panelists were Veena Warikoo of Genzyme, Benoit Mothes of Sanofi, Alex Brinkmann of Biogen Idec, and Veronique Chotteau of KTH and moderator Marc Bisschops of Pall [formerly Tarpon]). The consensus opinion from the panel was that a “change in mindset” was perhaps the most important hurdle, among those that remain for broader adoption.
I agree with this answer, but I couldn’t help but reflect on the slow but steady progress the industry is making in moving towards adoption of continuous processing methods. Much of the panel discussion at this year’s conference was devoted to practical aspects of implementation. Six or seven years ago, I participated in a similar panel where the focus was on whether continuous processing was economically viable or feasible at all in our industry. These are now more or less accepted – at least for some applications – and the questions have turned to how and where should we apply the technology. (Click here to reach our related blog from last summer).
Other signs of progress abound. During the conference, Pall announced its acquisition of Tarpon Biosystems and the related addition of the bioSMB platform to its product line. GE Healthcare recently announced an off the shelf version of its PCC system to enable semi-continuous chromatography with a standard system. Until recently, users were customizing Aktas to be able to operate in this mode. Finally, one speaker reported on implementation of a semi-continuous downstream process in a GMP manufacturing facility.
The reality is that adoption of new technologies is something that our industry can do – it just takes time. While most of the industry now accepts that single-use bioreactors can be used to manufacture not only clinical products but also some commercial ones, this was considered a dicey proposition only a decade ago. Risk-takers and early adopters needed to blaze the trail before the rest of us were convinced. We needed to see the overlaid cell growth plots between single-use and stainless steel bioreactors and many other data from case studies before getting comfortable with the approach. Product companies and vendors needed to collaborate to sort out problems that arose in early implementations, ranging from leachable/extractable issues to equipment design flaws. Now that many of these have been overcome, the industry is applying this technology far more broadly and reaping the rewards of adoption, including reduced capital investment and increased speed and flexibility in manufacturing operations.
I was encouraged by the constructive dialog around implementation issues for continuous processing at the BDP week. Although the specifics and the attendant benefits will most certainly differ from the industry’s adoption of single-use bioreactors, I expect a similar process to ensue as we learn how and when to use these powerful new approaches in our ever-expanding manufacturing technology arsenal. Continuous progress.
Blog article by: Tom Ransohoff