Miriam's experience with Stedim mirrors both my and Adam's experience. In my case, at Lonza in Slough, we had a big problem
with buffer handling in stainless-steel containers. The use of hold bags for buffers streamlined the whole operation and freed
up production floor space for more capacity. Early in his career, Adam worked for a small biotech company that did not have
the money to put in a conventional facility. Adam worked with Biowhitakker, a bag supplier, to look into using them to provide
bags for holding buffers. However, the challenges he faced were considerable: the bag designs were rudimentary and he had
to work with Colder Products to sort out the methods for making aseptic connections. Adam used this experience to challenge
the likes of Stedim and Pall to offer something better.
As the industry has matured and the suppliers have developed technologies for sterilization, design, and integration of components
(filters, tubing, and aseptic connectors), acceptance for the use of disposables for handling solutions has become widespread.
We have reached the point where handling solutions in bags is commoditized and every supplier must have the capability of
providing solution-handling systems. The future challenges are technical, business, and cost related. From Adam's perspective,
the technical focus for the future has to do with development of the disposable downstream components such as GE Healthcare's
disposable column. This will complement the advances in disposable cell culture bioreactors and contribute to achieve a totally
Leaving aside the technical challenges, Miriam's view is that although standards may be being set in the arena of extractables
and leachables, and sterility requirements, there is currently little attempt by the suppliers to standardize across product
ranges. Such standardization would allow the end user to interchange bags between two suppliers working with the same support
container. Lack of standardization complicates both the qualification of multiple suppliers and supply chain management. Such
cost and business-related issues will come into sharper focus as disposables integration becomes the norm. There is a need
for an industry forum where interested parties can debate competing claims: the ISPE is to be commended for setting up a Community
of Practice for disposables. I will be returning to these and other issues in the future columns and welcome your input.
Andrew Sinclair is the managing director of Biopharm Services, Chesham, Bucks, UK, +44 (0) 1494 793 243, email@example.com
.1 International Society of Professional Engineers (ISPE) set up a Community of Practice for disposables in 2007 whose mission
aims to create a global focal point of support for biopharmaceutical professionals working with single-use disposable technologies.