WHAT'S MISSING?

Any discussion of what's missing has the implied assumption that we are trying to achieve a totally disposable process, but this is not the case. "I would not talk necessarily about gaps in the disposable technology offering—it is a more a case of where does it make sense to use disposables for a given process," said one user. "The suppliers think that they can solve everything with disposables!"

Products. There are a few gaps in component offerings, however, one common desire is for a mature disconnection system that can be used several times. Users recognize, however, that we are just at the beginning of the technology developments in this arena.

Services. It is apparent from the feedback that there is some level of dissatisfaction on the service front, with some end-users demanding:

• Disposables suppliers guaranteeing a no-change policy for a 10-year period.
• More collaboration between suppliers, leading toward greater standardization of films, containers for bags, and components used in systems.

As the disposables market matures, there is also a requirement that the disposables suppliers think about the longer-term requirements of the industry rather than trying to impose single-source dependency.

Indeed, the way in which the disposables suppliers approach the market suggests that different companies and technologies are at different stages of maturity. The disposables suppliers who have been supplying the industry for many years have reached a level of maturity that allows them to approach the market thinking about the requirements for industrial implementation, whereas the suppliers who have arrived on the market more recently are still approaching the market from an innovators or early adopter point of view by considering only the technical issues without considering the users' requirements from a business perspective for things such as consistent quality and supply chain security.

If a larger number of disposables suppliers were able to reach the required level of maturity, the end-users we talked to believe that this would enable a far greater deployment of disposable systems because the risk the end users are taking would be diminished. As one user said, "Our company has quite frequently walked away from certain disposables implementations due to the lack of maturity of the supply chain and lack of availability of dual sourcing."

ENVIRONMENTAL MATTERS

It is apparent that many companies are concerned about environmental issues. This in part is being driven both by good stewardship and by legislation. Many of the companies we have talked to have internal initiatives to reduce their carbon footprint. However, there is always a question of the methodology used to determine where to start and where to finish when comparing stainless and disposables. Again, one user illustrates a fairly typical viewpoint. "We do have an internal initiative around environmental and operational sustainability," he said. "We also talk about the concept of green procurement ... the article, 'The Environmental Impact of Disposable Technologies: Can Disposables Reduce Your Facility's Environmental Footprint?' has been widely read in our organization and has generated considerable internal discussion."¹

SUMMARY

With increasing titers opening up, the opportunity to work with smaller-scale processes, the need for highly flexible facilities, and the need to drive out costs in biomanufacturing by a factor of ten, there is a huge potential in the future for much broader disposables implementation in biomanufacturing. The suppliers will have to listen and respond to industry requirements, however. If they don't, the uptake of disposables in commercial operations will be limited.

Discussions and interviews that the authors carried out with experienced industry end-users, however, highlight a number of these requirements in which end-users would like to see the disposables suppliers mature to build the level of confidence required for a much broader implementation of these technologies.

• Mature commercial positioning in relation to cost management
• Adoption of an industrial approach to disposables implementation as opposed to a niche approach. This links into the request by end users for technology standardization and more openness among the suppliers to work together to enable the requirement for dual sourcing.
• Better understanding of the relative costs of disposables versus traditional systems throughout the product lifecycle
• Reproducible quality
• Robust supply chain with no-change guarantees for a 10-year time frame
• Designing intuitive disposable systems that minimize the risk of operator error through clever design.

ACKNOWLEDGEMENTS

In preparation for this article, we talked to a wide range of users. We would like to thank all those individuals for giving up their time to talk to us. In particular, we would like to thank the two industry experts we interviewed who are actively leading teams carrying out disposable system evaluation and implementation. One is the head of enabling technology for a major monoclonal antibody manufacturer, and the other is the head of disposable technology implementation for a major vaccine manufacturer.

Andrew Sinclair is the managing director and Miriam Monge is the vice president of marketing and disposables implementation, both at Biopharm Services, Chesham, Bucks, UK, +44 1494 793 243, disposables@biopharmservices.com
Monge is also the European chair of ISPE's Community of Practice for Disposable Technologies.

REFERENCES

1. Sinclair A, Leveen L, Monge M, Lim J, Cox S. The environmental impact of disposable technologies. Supp to BioPharm Int. 2008 Nov;4–15.