The industry is in transition. There is a renewed focus on cost and efficiency, and as a resilt, we are seeing a major uptake
in the use of disposables technologies. The opportunities provided by disposable technologies also come with risks, however,
and single-use technologies are not a homogenous toolkit that provide a simple fix. Rather, the market offers a mixture of
technologies at different states of maturity from a wide variety of suppliers. This variability poses challenges in terms
of supply chain and technical risk. In this article, we present the end-user perspective. Since the last column, we have visited
Interphex in New York, and talked to a number of industry leaders from the manufacturing and contracting manufacturing sectors
for their perspectives on the real concerns arising from the adoption of disposable technologies for the commercial manufacture
of biotech products.
CHALLENGES AND OPPORTUNITIES
When we discussed the challenges and opportunities posed by disposable technologies, we asked a number of questions. Do disposables
really change the way end users look at and manage operations? Do disposables technologies change the way they view and operate
the factory? How can the opportunities be maximized, and the downsides be minimized?
Challenges. From these conversations, several key challenges emerged.
Cost. There are significant differences in the announced pricing from one supplier to another. Many suppliers try to play on the
fact that they have a unique technology and accordingly charge a significant premium, whereas others take a pragmatic approach,
thinking about long-term relationships. One interviewee said that cost does indeed matter. "The end-user may appreciate a
new disposable technology for the benefits it brings in terms of simplifying equipment preparation, cleaning, etc., but will
not adopt this technology if it actually works out [to be] more expensive than the technology the end-user was working with
previously," he said.
Quality and reliability. By moving to disposables, the end user is effectively outsourcing a major part of manufacturing and quality management. As
a result, the user must work very closely with the supplier to ensure that robust quality throughout the manufacturing process
Supply chain. Supply chain risk is a common sourse of complaints related to dual sourcing and consistency of supply. One user commented
that his (her) company's zero change policy requires careful planning. "We ask our disposable suppliers contractually for
a guarantee of supply without change for a 5–10 year period," he (she) said. Such a policy means that the user has to consider
the supply chain in most minute detail in terms of component and film suppliers and ensure that all the necessary contracts
are in place.
Ergonomics. One user noted the operator's role in terms of handling of large-scale containers and the manipulation of tubing sets. "When
working with disposables, there is a much greater dependence on the operators themselves. If they make a manipulation error,
this could contaminate the whole process," he said. "We work with our suppliers in designing disposable systems that are as
intuitive as possible, are idiot-proof, and so minimize the risk of operator error."
Opportunities. The opportunities presented by single-use technologies for manufacturing tend to relate to flexibility of operation, ease
of product changeover, and the removal of wasted activities in terms of preparation and cleaning. "The great opportunity with
disposables is that we can spend more time concentrating on manufacturing steps, the productive steps, and get rid of preparation
work," said one interviewee. Users also see significant benefit from disposables when applied to process development, where
fast turnaround in pilot and clinical supply facilities are extremely important.