BARRIERS TO ADOPTION
BioPharm: What barriers do you see to more widespread adoption of single-use chromatography?
Grund (GE Healthcare): Weighing the pros and cons will give a different answer from case to case and it really depends on the application in question.
Not all applications are best suited to disposable chromatography columns, speed is not the only goal. Operational efficiency
can be addressed in other ways and many hybrid solutions are possible. Another factor is obviously that large, hard-piped
facilities in existence around the world—dedicated to a small number of products—can operate very economically and there is
little motivation to refurbish them. There are also many smaller facilities based on conventional stainless-steel approaches
and these will probably only be replaced with single-use components when the pressure on flexibility and facility throughput
The strongest push towards single-use is in multiproduct facilities that switch products frequently, especially at small scale,
for example, in process development, production for clinical trials, or contract manufacturing. Here the barrier is more related
to a conservative attitude with general reservations about using disposables. Manufacturers are concerned with issues such
as risks from leachables, poor documentation, and increased risk of operator error.
Bisschops (Tarpon): One of the most important barriers to introducing disposable chromatography is most likely the sunk capital in legacy facilities.
We do see, however, a growing trend in even existing legacy facilities moving to disposables in process steps where the facility
design itself becomes a limitation either because of increasing titers, holding tank capacity, or water-for-injection capability.
This is where disposable continuous processing can have a huge impact.
Thompson (Polybatics): I think one of the challenges that equipment suppliers haven't really addressed is the cost issue. Single-use manufacturers
haven't really addressed the cost aspect—they've just shifted them from one-time upfront to ongoing operational expenses.
I think you have to get to a 30% savings or more before manufacturers will take the investment they have in existing processes
and systems and shift them. Otherwise, there just doesn't seem to be the economic incentive to shift to disposables.
Will there ever be a completely disposable system? There will still be some components of any system, whether it's membrane
or resin-based, that will be reusable. I do believe there will be systems on the horizon as technologies evolve that are truly
disposable. Whether that means systems that are single-use, or say, 10 uses for a campaign... My suspicion is that it will
be more along the lines of using a unit for a campaign, then once the campaign is done you get rid of it. So you still get
the benefits of disposablility but leverage some of those costs over 10 or 20 cycles.
Mann (Merck Millipore): One barrier is the availability of systems, including systems that have gradient capability. Greater capability and system
choice will likely drive adoption.
A second barrier is the availability of true single-use devices or prepacked columns. Although single-use membrane adsorbers
are being adopted, especially for flow through applications, the relatively lower capacity compared with resins limits application
for bind-elute applications. Consequently, higher capacity membrane or similar device format could facilitate adoption. Alternatively,
or in combination, lower cost, prepacked columns would make single-use operation more attractive.
Tingley (Repligen): For me, the way to get adoption of these chromatography products is to make them easy to adapt to what people are doing now.
If they can get a prepacked column that's prepared in exactly the same way as their glass column, that's used exactly the
same way as their glass column, and gives exactly the same results as their glass column, that will be the first step in making
chromatography disposable. With that, I think, will come pressure to look for alternatives to make chromatography truly single-use.
From a vendor's point of view, for years we've been having great conversations with the biopharma industry about introducing
new technologies and making changes. But, the actual adoption rate of game-changing technology is poor. Just because of the
way we do things in this industry, we're more likely to be evolutional than revolutional. As long as people can think about
how they can use the product as a disposable or semidisposable step and it makes sense to them, then they can easily see it
fit within the confines and contraints of their own company's regulatory philosophy and guidance, and it's an easy step to
make. This is what will take us down the path to truly game-changing technology in the years to come.