BioPharm: How are the US and European regulatory authorities responding to disposables?
Morris: Well, you tend to see more and more adoption of the technology, so they are becoming more familiar with it. The main concerns
usually are the approach toward extractables and leachables. More recently, BPSA had a group meeting with the FDA to help
the education from the suppliers' perspective on guidelines for extractables and leachables testing that suppliers typically
do today. So I think it's a matter of time and exposure, and I have not heard of any issues where people are saying this is
not a technology we should move forward with.
BioPharm: Are there any best practices that companies can follow for transitioning to disposables?
Morris: Definitely there are more and more that we are seeing in the industry and BPSA is a group that does promote the adoption of
the technology, and the supplier base has come together to put together guidance documents and you can see those on our web
site. It is a great forum to help with that process.
BioPharm: Do you think it is feasible to have a fully disposable manufacturing process, and if so, how soon do you think it will happen?
Morris: Well I think that really depends on the scale. Today, at a small scale you can have a fully disposable process. At the larger
scale, at a 20,000-L bioreactor process, right now that's not really feasible. Over time, perhaps, we will get there but it's
really going to be driven by the customer base and what their requirements are and if it is a value for them going forward.
Roberta Morris is the director of marketing at Charter Medical Ltd.