ARE CRUCIAL FACTORS LEVELING OFF?
The reasons cited by biopharmaceutical manufacturers for increasing their usage of disposables shows relative consistency
from past years. For example, a few years ago, "eliminating cleaning requirements" took the top position over "decreasing
risk of cross-contamination," as the dominant reason for increased usage. This year, 48.5% of respondents indicated that eliminating
cleaning was a "very important" reason, holding consistent over the last few years.
However, many respondents are slowly reducing the importance they are putting on individual product attributes. This reduction
may reflect a maturation of this segment. As the industry becomes more aware of the attributes and benefits of disposable
usage, and as the use of disposables increases, decision-makers' needs and specific reasons for increasing usage continue
to level out. For example, when considering all users, "Decreasing risk of cross-contamination" as a "very important" reason
saw a decrease this year to 42.4% (down from 50% last year) of users. Much of this stabilization may be the result of greater
experience and awareness of these devices.
WHERE DEVELOPERS AND CMOS DIFFER
BioPlan found new distinct perceptions between CMO and biotherapeutic developers when measuring their top reasons for increased
use of disposables. According to Dr. Abdul Wajid, senior director of process sciences at XOMA (US) LLC, "Significant differences
with biotherapeutic developers reflects CMO business model which has multiple projects pipeline, generic quality documentations
enabling them to achieve faster turn around resulting in higher productivity and better use of plant time to maintain business
CMOs in particular can save on facility or campaign costs, which can also reduce operating costs and capital investments.
The flexibility and quick turn-around times between process runs can also improve efficiency, which can reduce costs. These
savings can be passed on to the client. This is the result of the CMO being able to perform different processes within the
same facility. CMOs often use disposables to reduce risks of cross-contamination between campaigns, and are motivated by the
need to get a facility or project up and running quickly. By contrast, biotherapeutic manufacturers tend to be more motivated
by the need to keep maintenance costs low. If suppliers or associated standard-setting bodies are able develop methods for
standardizing disposables, it would enable the use of secondary vendors, which is an increasingly important factor today.
"Very important" reasons for increased use of disposables that are much more applicable for biotherapeutic developers:
- Reduce time to get a facility up and running (44.6% of developers vs. 34.6% of CMOs)
- Reduce water requirements (25% of developers vs. 8% of CMOs)
- Lower annual maintenance (22.2% of developers vs. 12% of CMOs).
"Very important" reasons that are more applicable for CMOs:
- Decrease risk of product cross-contamination (56.0% of CMOs, 39.4% of developers)
- Reduce space requirements (36% of CMOs, 19.7% of developers)
- Faster turnaround time (40% of CMOs, 33.1% of developers).
These crucial reasons are reflected by the recent expansion of the CMC Biologics facility in Copenhagen to include a 2000
L single-use bioreactor. According to Gustavo Mahler, chief operations officer at CMC, the advantages are clear: "Reduced
project times, reduced risk of cross-contamination resulting in increased process reliability, and reduced batch manufacturing
costs that will allow CMC Biologics to be even more competitive," he says (3).