Automation, single-use systems, smaller footprints, and new drug delivery devices define trends for fill/finish outsourcing.
Fill/finish operations have traditionally been among the most commonly outsourced biopharmaceutical manufacturing activities. Biologics final formulation and dose filling processes require rigorous attention because they occur at the end of costly biologics manufacturing where product safety value is highest. Traditional filling involves stainless steel equipment connected through reusable valves, tubing, and piping. And because of the need for specialized equipment, expertise, and care, much of this work has been outsourced.
Stability and caution are hallmarks of this segment, and fill/finish operations are not typically characterized as part of the more rapidly changing segments. However, according to BioPlan Associates’ 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), this segment remains an actively evolving area where innovation and new technologies are improving product safety and cost of goods.
To determine how the rapid advances in other bioprocessing manufacturing sectors compare to fill/finish segments, respondents to BioPlan’s survey identified the following as the most important trends in fill/finish today:
Outsourcing of fill/finish operations today remains a key fill/finish trend, but the percentage increases have flattened. Data indicate that almost three-quarters (74.2%) of biomanufacturers today are outsourcing fill/finish activities to at least some degree (1). This is the continuation of a steady trend of more widespread outsourcing of fill/finish dating back to 2010, when 6 in 10 respondents reported outsourcing at least some fill/finish activities. This year, fill-finish places fourth on a list of 24 outsourced activities, trailing only analytical testing of bioassays (89.7% outsourcing), plant maintenance services (80.4%), and toxicity testing (76.3%).
Further evidence of the strong state of outsourcing in the fill/finish market is also available. Respondents were surveyed concerning the average percentage of outsourcing done today (Figure 1). As expected, on average, respondents estimated outsourcing fill/finish operations to the largest degree. Indeed, the data indicate that more than one-third (35.6%) of this activity is outsourced. This figure is within the 32-27% range witnessed this decade. It also makes fill/finish easily the most heavily outsourced activity of the lot, far ahead of the next one on the list, analytical testing of bioassays (27.4% of activity outsourced).
Outsourcing of fill/finish activities is clearly commonplace and no longer considered part of the critical trends that make up the bioprocessing market. While this may change, as more innovative single-use processes and isolator technologies are introduced, filling will remain a conservative segment.
There’s reason to believe that the industry will see even more outsourcing of fill/finish activities to CMOs. Survey data demonstrate that a sizable share of the industry is planning to significantly increase its outsourcing of fill/finish operations (1).
Specifically, one in four respondents (25.4%) expect to outsource fill/finish operations at “significantly higher levels” in the coming 24 months. That figure is up from 19.7% in 2015. Still, relatively speaking, fill/finish operations are set for bigger increases than virtually any other activity measured. The only area respondents expressed greater enthusiasm about the future outsourcing was for analytical testing of bioassays, where close to one-third (31%) plan to significantly expand. Fill/finish operations even nudged API biologics manufacturing in planned increases, despite the latter’s multi-year upward trend on this measure.
It’s interesting to view the extent to which fill/finish operations are outsourced within the context of in-house capacity. To this end, there is sufficient in-house capacity for current biopharmaceutical products, even without adding shifts or additional equipment. That view may not be held by some small-molecule fill/finish facilities, which have been operating at near-capacity due to consolidations and regulatory actions.
BioPlan estimated capacity utilization by looking at current usage against maximum capacity per shift using respondents’ current configuration for number of shifts and equipment set-up and found that capacity utilization averaged:
The basis for these estimates excludes CMOs, who are major players in this industry, such that these estimates relate to in-house capacity only. This suggests that outsourcing of fill/finish activities isn’t being driven primarily by a need to expand capacity. Specialized CMOs, instead, may be viewed as having more sophisticated techniques and newer technologies. Those with newer technologies may have a competitive advantage, particularly considering that more than one-third of fill/finish respondents this year don’t plan to add any new technologies during the next 24 months.
The industry’s desire for improvements in fill/finish services has eased a little this year, after growing in years past. Additionally, increased outsourcing to CMOs is not seen as the key trend that it was last year.
Fill/finish activities and operations are the most heavily outsourced of any biomanufacturing activity, and each year more respondents report outsourcing fill/finish activities to at least some degree. Moreover, many respondents see significant increases in fill/finish outsourcing on the horizon. Outsourcing of fill/finish activities is certainly entrenched, even if there is ample in-house capacity. That doesn’t mean it won’t be a competitive environment for CMOs, who may well be expected to adopt or already be using technologies such as closed-vial filling and single-use fill-finish devices. All in all, outsourcing may not be buzz-worthy for fill/finish this year, but the state of fill/finish outsourcing remains quite healthy.
1. BioPlan Associates, 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (BioPlan Associates, Inc. Rockville, MD., April 2016).