The Value of Flexible Technologies
If you had any doubt that single-use technologies are becoming broadly accepted for commercial biopharmaceutical manufacturing applications, the recent BPI-West conference should put them to rest. The infrastructure and systems are being established at many large manufacturers to enable them to control single-use supply chains for both clinical and commercial manufacturing. This does not mean that all the problems have been worked out – far from it. Many problems are just being discovered, and many are undoubtedly still unknown; issues with bag failures, leachables, lack of industry-wide standards in materials and fittings, mushrooming numbers of “standard” assemblies and others were reported.
Collaboration between suppliers and end-users (either bilateral or through industry/professional organizations, such as BPSA and ASTM) was widely recognized as being crucial in establishing effective solutions to developing issues. As Parrish Galliher, CTO USP, GE Healthcare, pointed out during a panel discussion, “[the single use] industry supplying for commercial processes is only several years old – it took at least a decade to get stainless steel right,” highlighting the need to be patient and temper expectations as we work through the issues.
Nevertheless, the reality is that the value of single-use technologies is compelling enough in many cases to drive implementation forward even as the relatively immature infrastructure is growing and straining to support the market demands. Why is this? Part of the answer lies in the enormous uncertainty in forecasting future demand requirements for commercial biopharmaceutical products. In addition to uncertainty in whether or when products will receive market approval, product requirements post-approval are also highly uncertain.
Against this backdrop, technologies that enable flexibility in bringing manufacturing supply on-line and enabling multi-product manufacturing efficiencies have significant value, even if their cost of goods are higher on a unit basis. During the conference, we described a modeling approach that can help quantify the value of flexible technologies for high-risk supply chains, and we are increasingly using these types of tools in optimizing manufacturing strategy for our clients. I also believe this helps explain why single-use technologies – despite the supply challenges and growing pains – are being adopted at increasing rates in our industry.
Is continuous processing next?
Blog article by: Tom Ransohoff