We were especially curious to learn how manufacturers were purifying their protein-based products. We learned that 72% use
ion-exchange chromatography, 62% use membrane-based filters, and 52% use Protein-A-based chromatography, often thought of
as the standard for mAb purification (see Table I).
Table I: Purification technologies used for protein-based drugs (multiple responses allowed).
There has been an ongoing debate among equipment vendors about the merits of disposable, often plastic, versus stainless-steel
equipment for biopharmaceutical manufacturing. Vendors tend to cite cost, ease of use, and reduced opportunities for contamination
as advantages of disposable equipment.
We thought it would be interesting to learn what equipment people are actually using and their attitudes about the equipment
classes they're not using. The results were illuminating. Only 7.5% are using all disposable equipment, 19% are using all
stainless steel, and the vast majority—74%—use a combination of stainless-steel and disposable equipment (see Figure 5).
Figure 5: Stainless-steel versus disposable equipment use.
Next, we wondered whether equipment classes in any way followed the type of product manufactured. For instance, do protein
manufacturers have a preference for a particular equipment class compared with manufacturers of nucleic-acid-based drugs.
We found that regardless of product type, the choice of equipment used tracked very closely to the group as a whole. Eighty-one
percent of mAb producers use a combination of stainless-steel and disposable equipment; 4.2% use all disposable equipment;
and 15% use all stainless-steel equipment. Among producers of proteins other than mAbs, the results were similar: 80% used
a combination; 5% used all disposable; and 15% used all stainless steel. All-disposable use was highest among manufacturers
of nucleic-acid-based drugs (10%) (see Table II).
Table II: Type of equipment used to manufacture biopharmaceuticals.
Interestingly, users of stainless-steel equipment are most inclined to switch to disposables and not the other way around.
Of those currently using all stainless-steel equipment, 21% are considering switching to disposable equipment, and 52% are
not. Yet, among those using all disposable equipment, 65% report that they will not go back to stainless-steel equipment,
while the remaining 35% do not know.
Figure 5A: Perceived advantages of disposables (all biopharmaceutical manufacturers, regardless of equipment used). Total
exceeds 100% because multple responses were allowed.
We noted some marked disparities in perceptions and realities about various types of equipment, depending on what manufacturers
are currently using (see Figure 5A). Specifically, the perceptions of disposable equipment among users of stainless-steel
equipment were more negative than among those who actually use disposable equipment. For example, among manufacturers using
all stainless-steel equipment, only 7.3% think that process reproducibility could be an advantage to all disposable equipment.
In contrast, 53% of those using all disposable equipment cite process reproducibility as an advantage. Only 68% of those who
use stainless-steel equipment believe that contamination could be reduced by using all disposable equipment, versus 82% of
those who actually use all disposable equipment (see Table III). Only 39% of stainless-steel equipment users think disposables
would be easy to use, as opposed to 71% who use disposables and find them easy to use. Only 10% of stainless-steel equipment
users think it would be easy to incorporate process analytics into a disposable-only facility; 24% of those who actually use
disposables say that it's easy to incorporate process analytics into their facilities. Finally, about 20% of stainless-steel
users believe regulatory bodies will accept the use of disposables; 35% of those that actually use disposables cite regulatory
acceptance as an advantage.
Table III: Perceived advantages of using disposable equipment.
It also happens that stainless-steel equipment users underestimate some of the challenges inherent in disposable use. Among
those who use all disposable equipment, 44% cite leaching of disposable components into cell-culture medium as a challenge,
compared with 28% of all-stainless-steel users. A higher percent of disposable users—38%—find inadequate bioreactor volumes
a challenge, versus 26% of stainless-steel users (see Table IV).
Table IV: Perceived challenges to using disposable equipment.