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Transitioning from stainless steel technology to disposable technology in bioprocessing.
Live Interview from the 2008 BIO International Convention
Biopharm: The adoption and acceptance of disposable biorocessing equipment today seems to be growing. What approach are most companies taking? Are they mostly using disposables in new processes or are they integrating them into existing processes?
Morris: I would say it's really a combination of the two. Historically, with capital already invested into facilities, changing out 100% doesn't make sense. You can use those stainless-steel systems that are in place and integrate specific modules of disposable technology. Steps such as media and buffer addition are easy to implement fairly quickly. Seeding bioreactors are typically what we see integrated into an existing stainless-steel process. So it's really a combination of the two.
BioPharm: Are the considerations very different depending on whether you are developing a new manufacturing process or integrating disposables into an existing process?
Morris: There are a couple of areas that have to be considered. One in particular is that if you have got an existing system in place that is constructed of stainless steel, most likely that will require steam sterilization, so some of your connector technologies to integrate will have to be different. It will have to be able to take that pressure, steam, and heat that it would be subjected to. So some of the connectology will have to be different as well as the design of construction in general.
BioPharm: What do you think is the biggest hurdle that most companies face when considering a transition to disposables?
Morris: I think one of the most challenging points is just the approach to validation because it is different than stainless steel. For stainless steel you have got steam sterilization, which most companies are familiar with. And with single-use technologies, typically what you would see is gamma irradiation, something that suppliers are taking responsibility for. So the validation approach is different. Another topic would be extractables and leachables. That's more of a concern with the plastic technologies that are being used in single-use versus stainless-steel systems.
BioPharm: Is standardization an issue in terms of material for construction or things like the size compatibility of connectors?
Morris: Well, I would say that in terms of materials of construction, historically, if you look at filters, mostly the same base materials are present in a variety of different configurations. The films of bags tend to mostly be of a similar construction also. So there is some more standardization that I have seen over the years. Connectors are one that, again it depends on that duty cycle; if it is going to be steam sterilized, your construction materials will be different than if you are doing irradiation.
BioPharm: How are biopharmaceutical manufacturers handling the disposal of disposables? Has anyone measured the environmental impact at all?
Morris: There have been some presentations that I have seen recently at the IBC conference a couple of weeks ago, where there was a presentation from, I believe it was Genentech, that spoke about this issue. So there are some companies that are evaluating it. There are also some guidance documents that the Bioprocess Systems Alliance (BPSA) has provided to give some general guidelines on how customers can consider disposing of those components. I think it's an issue that will come up more and more, but you have to also weigh that with the energy consumption for producing WFI and also the water usage. So really the balance is how does the disposal question fit into the benefits you can receive, the savings on energy consumption.
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.