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?
Roberta Morris
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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.
