Equipment
Table I. Compound class versus equipment used.
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The push in biopharmaceutical manufacturing equipment has been toward disposable, single- or limited-use components. The advertised
advantages include reduced risk of contamination and a lower cost relative to the high capital outlays required to purchase
the more traditional stainless-steel equipment. In addition, disposable equipment is supposed to eliminate cleaning and cleaning
validation steps, which may also indirectly make them an economical choice for some manufacturers.
We have been interested to see how quickly disposable equipment is being adopted by biopharmaceutical firms. We've also been
curious about the attitudes of pharmaceutical scientists who actually use disposable equipment versus the attitudes of those
who don't. In some cases, we've noted marked disparities, both positive and negative, in assumptions about disposables between
those who have experience with them and those who don't.
Table II. Perceived advantages of disposable equipment versus equipment actually used (multiple answers allowed).
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We were interested to discover, for example, that there has been no statistically significant migration from one to another
type of equipment since last year. Hybrid systems—composed of both disposable and stainless-steel components—remain the most
popular, with 72% of respondents using them (a slight decline from last year's 74%). At 20%, the second most popular equipment
class is stainless steel (up from 19% last year). Disposables remain the choice of only 8% of respondents, about the same
as last year. Nevertheless, some respondents indicated an intention to move to a different type of equipment. Nineteen percent
of respondents who currently use all stainless equipment are considering moving to a hybrid system, and another 5% are considering
going to all disposable. No one currently using all disposable systems is thinking of moving back to completely stainless
systems, but 8% are planning on incorporating some stainless equipment when they move into hybrid systems. About 3% of respondents
currently using hybrid systems are thinking of moving to all stainless systems, and 7% are planning on moving to all disposable
systems.
We also saw planned migrations between equipment types when we broke down the usage statistics according to compound class
(see Table I). Four percent more manufacturers of therapeutic m Abs use all disposable equipment this year versus last, brining
the total to 8%. There was a corresponding decline of 4% relative to last year in the number who report using hybrid equipment,
down to 77%. As they did last year, 15% of m Ab manufacturers use stainless-steel equipment.
Table III. Perceived disadvantages of disposable equipment versus equipment actually used (multiple answers allowed).
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We noted no significant shifts in equipment use for manufacturers of protein-based drugs other than mAbs, nor for those producing
nucleic-acid-based products. The largest movement took place among manufacturers of cells for tissue- and/or cell-based therapies.
Disposable use for these manufacturers is up 5%, to 13%, and hybrid use is up 4% to 81%. Only 6% of nucleic-acid drugs use
stainless equipment, reflecting a 9% decline over last year..
We were also curious about the attitudes toward disposables among users of the various equipment classes. One of the bigger
surprises was that 20% of users of stainless equipment and an equal number who use hybrid systems think an advantage of disposable
equipment is the ease with which automation can be introduced (see Table II). In contrast, no one—0% of respondents—who actually
uses disposables thinks the equipment is easy to automate. On the other hand, those who use all stainless or hybrid systems
grossly underestimate the overall ease of use of disposables. Fifty-one percent who use stainless, and 65% of hybrid users
think disposables are generally easy to use. In contrast, 82% who actually use disposables report them to be easy to use.
Figure 5: Functions outsourced (multiple answers allowed).
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Thirty-one percent of respondents who currently use stainless fear that processes are not reliably reducible with disposable
equipment (see Table III). Only 18% who use disposable equipment and 18% who use hybrid equipment report that. Those who use
disposables find that process analytics are more difficult to incorporate: 27% versus 17% stainless users who think that.
Those who use stainless equipment and hybrid equipment also seem to overestimate the challenge of assembling a disposable
production train consistently: 22% of stainless and 21% of hybrid users believe that consistency of assembly would be a challenge,
versus 0% who actually use disposable equipment.
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