The biopharmaceutical manufacturing industry has undergone many changes over the past decade, ranging from better expression systems to new modular and flexible facilities and the emergence of single-use devices. Each of these trends, however, is being driven by the need for productivity and efficiency, according to BioPlan Associates' 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production¹.
BioPlan Associates' annual study analyzes the biomanufacturing industry, detailing the ways manufacturers and suppliers are actively streamlining bioprocessing to cut down drug development and commercialization timelines. Part of the comprehensive analysis includes top industry trends identified by biomanufacturers as critical to improving operations. This year, and in keeping with established trends, the industry is again focusing efforts on strategically improving its productivity to address chronic inefficiencies:
• Manufacturing productivity/efficiency (17.2 percent of global biomanufacturers);
• Downstream processing advances (11.7 percent)
• Manufacturing cost reductions (10.6 percent)
• Single-use system implementation and integration (8.9 percent)
• Biosimilars/biogenerics (8.9 percent)
Although some respondents continue to indicate they must first address acute pains such as improving their downstream processing bottlenecks and reducing costs, once these areas are attended to, we expect to see continued strategic focus on general productivity. For technology innovators and suppliers, this essentially means any new product will need to clearly demonstrate how it will improve a facility's process efficiency — not just how it will lower operational costs.
Some of the interesting (and likely short-term) trends related to acute operational problems include downstream processing emphasis (ranked #6 in last year's study), and a drop in interest in biosimilars (See Figure 1, ranked #2 last year).
This year's top trends are all related in their drive for greater efficiency and productivity in the manufacturing process. With that in mind, we delve into several of these top trends to identify the ways in which they are helping transform production strategies.
IMPROVING PERFORMANCE INCREMENTALLY
Our annual survey identifies reasons single-use devices have enjoyed rising penetration rates in recent years: More than two-thirds of respondents this year (69 percent) report "significant" or "some" improvements in biomanufacturing performance at their facility over the past 12 months owing to the use of disposable devices. Closely following, 68 percent report some level of performance improvements from overall better control of processes. These were top areas most manufacturers associated with performance improvements in last year's study, as well.
The 2015 data are broadly consistent with last year's results, though not without some movement. This year for example, fewer respondents attributed performance improvements to use of disposable devices and better control of processes, despite these remaining the technologies contributing to improvements for the largest share overall. What's the primary reason? More than 90 percent of facilities are using single-use/disposable technologies in some capacity and are now simply evaluating "how" and not "if" they will integrate them more comprehensively into their bioprocessing strategy. The 12th Annual Report reveals a large percentage of the industry is actively modeling future manufacturing strategies, as they compare "stainless-steel" options versus "single-use/disposables" technology.
The study also identified areas that respondents feel are actually improving performance. For example, this year 66 percent attributed improvements to better analytical testing. This was consistent with perceptions in past years.
Not too surprisingly, single-use devices continue to disproportionately benefit contract manufacturing organizations (CMOs), where 86 percent were reporting improvements to their productivity, compared with biotherapeutic developers (66 percent). These disposable devices are well suited to the CMO business model that deals with multiple products and requires fast turn-around times. In general, CMOs tended to see more improvements from the factors we identified than developers, likely due to their being involved with more products and bioprocesses and therefore having more opportunities to see improvements. These improvements come from a broad range of areas such as better design of experiments to improved validation services. On the other hand, biotherapeutic developers are seeing greater improvements than CMOs from optimized cell culture processes and more automated control of processes.
Overall, it's encouraging to see that the industry is experiencing manufacturing performance improvements from such a broad range of factors: Of the 15 areas measured, a majority of respondents noted specific improvements owing to implementation of at least 10. This represents the broad focus on bioprocessing efficiency and productivity, with biomanufacturers seeing results from areas ranging from more automated control of processes to better operations staff training. These incremental improvements compound over time to result in more streamlined manufacturing of these biopharmaceutical products, which are accounting for an ever-growing share of the pharmaceutical product pipeline.