systems a lot of the engineering would be performed by an
end-user’s internal resources or a third party contractor.
This isn’t necessarily negative, but it can be a bit of a paradigm shift and it requires that the supplier possesses a
high level of single-use systems engineering insight. Creating
strong ties between an end-user’s engineering team and the
single-use systems engineering team is very advantageous
for both parties.
Will disposable technologies ever replace stainless steel?
Gregg Larson, Product Manager, Parker domnick
hunter: Single-use solutions have already replaced the use
of stainless steel in many processes. However, there will
continue to be a need for stainless steel in some processes
where single-use equipment is not appropriate. For example,
when the host cell is E. coli, homogenization after harvest
involves very high pressure, up to 21,750 psi, which is currently not possible with single-use technologies.
Furey: I think for cell culture it definitely will when we
are talking about Phase 1 clinical production, but maybe for
Phase 2 and 3 as well. The potential for cost cutting during
clinical production is great with single-use systems and I
think we could definitely see a move away from stainless
during that portion of development.
JD Larson: I do not believe that disposable technologies
as they are now will replace stainless steel systems and
it’s difficult to envision any technology leaps that will significantly change this balance. Many pharma-bio and other
processes will always require the pressure and vacuum handling abilities of legacy equipment. Limitations on single-use
also include the heat transfer rejection needs of reactive
and other intensive processes and the uptake and agitation
needs for many fermentation processes.
Who is pushing the development of new single-use technol-
ogies – vendors of equipment or the industry?
JD Larson: We think the development of new single-use
technologies is being driven both by the end user and the
equipment vendor. However, because of the recent rapid
consolidation of both communities by mergers and acquisitions, there are significantly fewer equipment sources and
well as fewer buyers in the marketplace. Going forward, this
lack of diversity may limit innovation to just a few competing systems.
Butler: I think the industry is pushing the development
of single-use technology. When a customer replaces a stainless steel system with single-use, they then look at other
processes for single-use technology. Often this new process
requires new development. I think it’s very important to
capture the voice of the customer to fill in the gaps for single-use technology.
Jewett: I think the best listeners are the people who are
What do you see as the short-term future for disposable
driving single-use innovation. They usually are in technical
sales, marketing or service functions and have the opportu-
nity to talk to users and hear what’s really bothering them.
They hear more than just what people say; they hear what’s
behind it. If someone says “I need a way to be sure my
cleaning process for this tank is completely foolproof” you
could respond, “How can I help clean his tank?” Whereas
a really good listener thinks “I wonder if he needs to clean
his tank at all?” The people who hear the complaint and un-
derstand the problem behind it, they are the ones pushing
Priebe: I believe we will continue to see the technology
gaps filled by supplier innovations. I think, though, that we
are about to see a shift in focus from the technologies themselves to the less obvious, strategically important factors.
Because the decision to use single-use technology is now
made at the strategic level, the execution and delivery of the
single-use system needs to support that strategic decision.
Major investments must be made to transform the assurance
of supply of single-use systems, including both business continuity and consistency of quality and product performance.
Jewett: I think that we’ll begin to see more use of disposables in applications that once seemed cost prohibitive. As
more disposable products enter the market they improve
efficiencies and reduce the costs to the point where it makes
sense to use disposables for pilot runs. It wasn’t too long ago
when the cost of those materials were too high for a lab to justify. I think we’ll definitely see a broadening of the applications
for which it makes sense and probably more partnerships between various parts of the supply chain that will enable us all
to work together to bring better systems to the market.
G. Larson: I think that single-use technologies will
continue to grow as the need for very large batch sizes
decreases with the improvement of protein yields and the
advancement of personalized medicine. Quality by Design
principles will be further enabled by the increased use
of motion and control technologies, such as automation
and robust single-use sensors to produce more consistent
batches at less cost. The materials used in the manufacture
of single-use products will continue to improve, driven by
industry and vendor organizations to reduce risk and improve safety for the patient. ■
“I think that we’ll begin to see more use of disposables in
applications that once seemed cost prohibitive. As more disposable products enter the market they improve efficiencies
and reduce the costs to the point where it makes sense to
use disposables for pilot runs. It wasn’t too long ago when
the cost of those materials were too high for a lab to justify."