WHERE HAVE SINGLE-USE SYSTEMS PROVED BENEFICIAL?
BioPlan evaluated 15 activities manufacturing organizations have implemented over the past year to specifically speed drug-development
timelines. The use of more disposables and single-use devices in manufacturing took the top slot, with 40.8% of respondents.
Following disposables was the use of more "platform'" downstream processes, at 37.7%. Analysis of those activities showed
that there was a cluster of mid-level activities that sped drug-delivery times. These included activities such as using "platform"
cell lines, improved in-process monitoring, use of "design of experiment" methods, and use of better chromatography resins.
At the bottom of the attributes was "use of different expression systems." However, because expression systems are typically
a one time decision, this is not unexpected.
Figure 2: Select activities implemented to speed drug development timelines identified by biomanufacturers versus CMOs.
Comparing biomanufacturers to CMOs, BioPlan found that for CMOs the number one activity implemented to speed drug development
timelines was the use of more disposables and single-use devices in manufacturing (72% vs. 42% for biomanufacturers).
Trends in the time required for product development and approval are closely related to productivity and cost concerns. This
year, the survey showed that acceptance of single-use devices is also being used as a cost-cutting action. Of 212 respondents
to this question, 35.4% accepted single-use (disposable) systems into clinical manufacturing operations to cut costs, while
19.3% accepted single-use systems into commercial manufacturing operations for the same reason.
PRIMARY REASONS FOR INCREASING USE OF DISPOSABLES
BioPlan identified reasons for the increasing trend towards use of disposable and single-use system components. Single use
disposable systems can provide cost savings, and sometimes these savings can be substantial compared with fixed stainless
steel systems, particularly with regard to larger systems. Indeed, as shown above, biomanufacturers are accepting single-use
systems as a cost-cutting mechanism, and according to BioPlan's data, almost 58% of respondents indicate that using disposables
to lower annual costs is a "very important" attribute.
However, as in previous years, direct cost reductions do not appear to be among the most widespread ("important" or "very
important") factors to these decision-makers. As in earlier years, the data indicate that disposable systems users are more
concerned about factors that will save time, reduce risks, and accelerate campaign turnaround. Increasingly, they are also
interested in reducing capital equipment.
The primary reasons biopharmaceutical developers and CMOs use these products are to:
- Eliminate cleaning requirements (90.2% indicating "important" or "very important")
- Reduce capital investment in facility and equipment (85%)
- Reduce time to get facility up and running (85%)
- Decrease campaign turnaround time (81.7%).
A significant shift is the focus on reducing capital investment in facility and equipment. Despite the loosening of budgetary
constraints, end-users are increasingly interested in seeing how disposable systems can help them avoid capital investments