3 Top Tips for Implementing Single Use Systems Today

Tony Hitchcock
Contributor: Tony Hitchcock
Posted: 12/13/2013

In this interview Tony Hitchcock, Technical Director at Cobra Biologics, shares his top 3 tips for implementing single use systems today and takes a closer look at the role of single use systems in continuous manufacturing.

Pharma IQ:Why do you think single use systems are not implemented more commonly across the biomanufacturing industry?

T Hitchcock:I think there's multiple reasons for that. One is they have to realise that single use and disposable solutions aren't the solution to all manufacturing problems, and that they may always have a hybrid nature because of limitations, whether scale or type of process operations. Secondly, the implementation and changing of new manufacturing processes is always very disruptive and expensive for customers and manufacturers, so there's always going to be a period of time until companies look to replace existing plants that may not be broken and still function. I think we have to accept those restrictions. Also, people still see that there's some degree of risk with single use systems, there's a level of unknowns, there's still some degree of concern about leachables and extractables and how they may infect or impact their product. And there's still concern over longer-term consumable cost of products and potential overreliance on suppliers, so manufacturers may be reluctant to actually switch to single use systems, especially for the whole process.

Pharma IQ:What are some of the challenges around scale-up?

T Hitchcock:It's a moving target in terms of the scale-up. Initially, the limitations tended to be that available scale of bioreactors and also the physical constraints of systems, especially ones around liquid transfer and pump in and also available separation systems. But I think we're seeing companies developing large-scale bioreactors, over 2,000 litres – potentially growing larger than that – for mammalian and also microbial systems. People seem to be getting those systems to work, so I don't think there's any difference in scale-up physically between single use and stainless steel systems; it's more trying to understand the mechanical limitations of the available single use systems, especially around pump in pressure, and how that constrains the actual process. I don't think there's huge differences between the scale-up of a process in a single use system or a stainless steel system. It's just looking at the actual individual process operations.

Pharma IQ:What would be your top three tips for someone just looking to implement single use systems now?

T Hitchcock:I think they are probably what they were a number of years ago, and the first is actually doing full technical evaluations and knowing that the process does work in single use systems, that they generate comparable material of the right quality. The second is going through vendor selection and design processes, doing a full assessment of the vendors, doing mock-ups of systems as well, the whole process, running individual operations. But then also looking at what back-ups you're going to get from your vendors and not just looking at the quality systems but also their capacity to deliver and maintain supplies to your required production schedules. The other I think is looking at the full implications of the implementing single use systems across a whole company in terms of impact on staff and training of staff systems, but also project flows throughout your company, the quality systems around that, and taking a holistic view of that rather than trying to just do it as a small, individual project. You need to understand the full implications of that project. If you do that, then it's possible to successfully implement single use systems, either for whole processes or specific operations.

Pharma IQ: What's your opinion on the regulatory landscape in this area at the moment?

T Hitchcock:I think it's still mixed. The feedback certainly that we have at Cobra is that the local regulators within the UK are very happy for us to use single use systems; they welcome them, especially in multiproduct facilities and diminishing the risk of product crossover. One of the real issues is actually trying to develop quality systems around that, where you have a greater dependence on outside suppliers bringing all your materials in. In fact, what we buy in these systems without any kind of overall basic standards; the standards for single use systems seem to be a large mixture of standards from other product areas. For instance, the leachables and extractables tend to rely on final product containers – the guidelines for that – but these are very different from that, where a product may only have very short-term contact with containers, and I think it's trying to develop more standard baseline requirements for materials that are going to be used in processing rather than final drop product storage. We need to get a much clearer landscape for both the suppliers and end users.

Pharma IQ: Is there a role for a single use system in continuous manufacturing?

T Hitchcock: I think there is. There's also already companies supplying those systems, both for upstream operations, in terms of some of the profusion systems that people are looking at have got built-in membrane harvest systems, for instance. There's already implementation of these, certainly into early-scale products using these in semi-continuous mode, and also even the chromatography areas when you've seen companies developing the simulated moving bed-type chromatography systems. There's very much an integration of those with the pre-packed columns that some companies are making. There's no reason why single use systems shouldn't be used in that. Clearly, there's a need to verify that you've got the required mechanical performance and the required leachable extractables over a longer period. From what can I see of it, one of the concerns is probably not so much about the bags but more things like sensors and the quality and durability of those, which if you get failures in processes would have significant impact. In theory, there's absolutely no reason why you shouldn't be able to use single use systems in continuous manufacturing, and also it might be a better way of managing the consumable costs for these devices, where probably you have lower consumable burning a continuous process than you would in a much more batched process. There's a clearly a lot of scope for development in that area.

Pharma IQ: You will be chairing the 6thAnnual Disposable Solutions for Biomanufacturing Summit taking place 18th – 20th February in Munich, Germany, is there anything, in particular, that you're looking forward to at the event?

T Hitchcock:  I'm looking at both trying to stimulate debate, especially on potential areas of single use systems in future manufacturing processes, but also understanding the economic drivers behind why people are or aren't adopting it. I would  like the meeting to be focused more on the workshops and the debates as it is on the specific presentations, so people get as much out of the meeting as they can and also have an opportunity to contribute and add to the knowledge base that we hopefully bring to the meeting.

Pharma IQ: Thank you so much Tony for sharing your insights. We look forward to some lively discussion and debate at the event.

Interview conducted by Andrea Charles.

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Tony Hitchcock
Contributor: Tony Hitchcock
Posted: 12/13/2013

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