Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, a study of biotherapeutic developers and contract manufacturing organizations’ current and projected future capacity and production.
Contract manufacturers more readily adopt new technologies compared to drug companies that manufacture in-house. In what areas are CMOs taking the lead?
CMOs indicate a significantly greater interest in new technologies that impact efficiency and productivity—areas that affect these contract service providers’ competitiveness. In our 13th Annual Report of Biomanufacturing, of the 21 areas of innovation tested, we found CMOs more interested in: chromatography, single-use probes and sensors, disposable chromatography, instrumentation, upstream process development services, etc. In comparison, biopharmaceutical innovators sought improved analytical assays and development, control systems, fill-finish services, and downstream PD services.
Why are CMOs early adopters?
CMOs may not always be the early adopters, but they frequently are the early evaluators; for their clients, they need to be on top of current innovations, and they need to be at the leading edge in terms of efficiency because that directly affects their productivity and profitability. Further, if they’re to maintain expertise in bioprocessing, they need to have a fuller ‘toolbox’ of options, innovation, and knowledge at their disposal than other manufacturers who may need to build out a process only once.
Commercial-scale bioprocessing lags clinical scale because legacy stainless steel systems continue to dominate large-scale bioprocessing. Further, because implementing a single-use commercial scale manufacturing strategy is much more likely for new pipeline products that were developed in single-use applications, the pipeline applications are what can be used to project the future of SUS at commercial scale. We also note that many biologics will require larger volumes that may not be appropriate to what is currently considered a typical max volume (e.g., ~2000 liter) for single-use scales.
Presently, about 85% of bioprocessing done at clinical scale is done using single-use devices. So this should be an indication of how the pipeline will affect commercial-scale bioprocessing once these products reach commercial scale. Some will stick with SUS, others will be done using stainless. That said, we asked biomanufacturers when they expect to see a 100% single-use commercial scale facility, and nearly 50% indicated they expected this within the next 5 years. Those same respondents noted that within 5 years, at least 50% of their own facility’s clinical and commercial unit operations will be done substantially using single-use systems. The trends in the US appear to be slightly more aggressive than in Europe.
What was the most surprising trend revealed in the 13th Annual Report and Survey of BioManufacturing? Why?
The bioprocessing industry, as a regulated environment, does not adopt novel approaches very quickly. So substantial shifts and trends tend to evolve over time. On the other hand, some areas of interest pop up relatively quickly, based on prospective benefits associated with a novel approach—even if it hasn’t yet been proven to be an effective option. For example, we asked respondents to consider new products and services required for the industry, “What are the top five areas you want your suppliers to focus their development efforts on?” Our objective was to identify ‘problems in need of solutions.’ In terms of interest in new products and their development, disposable products occupied four of the top five positions on the list. However, this year, ‘Continuous Bioprocessing: Downstream’ – a new option – rises to the top of the list (36.6%). This may not be too surprising given the large increase this year in respondents seeing continuous bioprocessing as the single most important trend in biopharmaceutical manufacturing today. However, when reviewing the current development status, and future hurdles for introduction of many emerging continuous bioprocessing technologies, it may be some time before we see them used in mainstream bioprocessing.