Jay Thompson, Associate Director of Bioprocess Development at Pfizer Animal Health, discusses the impact of the slow implementation of disposables for downstream processing and how Pfizer is getting around quality and regulatory challenges as they move towards commercialisation.
Pharma IQ: What are the hot topics in disposable solutions for biomanufacturing in general right now?
J Thompson: The hot topic for us, in the disposable field on the animal health side, is really downstream processing and implementing disposals in downstream processing. In terms of filtration, centrification, the equipment’s out there, but it’s slowly being implemented and people are deciding on the best equipment to use.
Upstream processing is pretty well established, with the use of disposables in large scale antigen or biopharma production, and most manufacturing facilities have implemented that to some degree, but the downstream processing has lagged behind.
The other hot topic, for us, is the use of disposable probes; pH probes, oxygen probes, temp probes, probes that use optical capability so they don’t go into a disposable piece of equipment, they don’t pierce the plastic on it. A lot of those are being implemented now. They’re probably not up to the capabilities of the standard probes but they’re getting close and this year they’re being implemented in all our equipment on site.
Pharma IQ: What were the main drivers at Pfizer for moving to disposables, if that isn’t too general a question?
J Thompson: I think the initial main driver at some of the sites was capacity concerns. There are some high capacity materials in terms of keeping up with production on some of the products. You have the choice, at that point, to build a large infrastructure to house a steel tank or you can use disposables, which are on casters and very moveable and you can change your footprint. That was one of the initial drivers.
The second one, on the Veterinary Med side, is we use a lot of exotic agents from the field and you don’t want to impact your production facility by introducing exotic agents. One way to keep that out of your steel tank vessels is to use some sort of plastic system that doesn’t have contact with any other of your products and then, when you’re done doing the run, you can incinerate that and get rid of it.
They were the two main drivers for moving to disposables and, as they’re implemented, you can really see the value from a cost perspective, which was a secondary benefit for moving forward with the disposables.
Pharma IQ: I wondered actually, when you were responding to that question, if you ever look to any of your peers to see what they’re doing and how do you think you fit in with the disposable solutions you are using?
J Thompson: Within Pfizer, we’re vet med, so we do have some cross-fertilisation with our human colleagues in terms of equipment, but also really at meetings like IQPC meetings; that’s where we kind of see where the field is. As we talk to vendors they usually have case studies where other companies have implemented disposables. For us, that’s how we see the pluses and minuses, before we lock into equipment. There are a lot of choices on the upstream side but once you lock into a piece of equipment you’re kind of married to it for a long period of time, so making that early choice, it’s critical to get as much info as you can. We were looking at meetings and input from vendors on which direction to go from the outset.
Pharma IQ: Where are your biggest challenges currently lying?
J Thompson: The biggest challenges for us, that we get a lot of feedback on, are the quality of the systems and what the regulatory requirements are of the system. For steam and place, clean and place, there are a lot of SOPs and validation that’s done with a steel tank. When you move to the plastic tanks, every time you assemble them it’s a completely new setup and so there are struggles, from a quality point of view, of validation of the systems.
The preferences would be to take advantage of these; that when you do a run you use it once and you’re done and that would be a validated run. There’s a real give and take with quality in terms of how you know the system that you’ve set up from plastic is validated, and then once you run it you’re done with it so you can’t carry it over to the next time. Quality and regulatory, for us, are big challenges now. The technology has proven itself already in our hands but that’s what we’re dealing with as we move these towards commercialisation.
Pharma IQ: What proportion of your biomanufacturing system is currently single use?
J Thompson: That is an interesting question. To venture a guess, 30% to 40% maybe would implement some sort of single use technology.
Pharma IQ: Is that an average figure, or do you believe that other companies probably have a higher proportion; maybe smaller companies?
J Thompson: Yes, I would imagine that contract manufacturing organisations are probably a much higher percentage in terms of the disposables. Big companies that have existing infrastructure, like steel vessels in place, are probably using disposables, much less because they already have steel tanks in place. They’re just slowly getting disposables in to the same areas. I think, depending on the size of the organisation, you may see a different skew to smaller organisations and newer companies skewing towards the single use completely. But, I don’t have exact figures on this, I’m speculating.
Pharma IQ: Do you at Pfizer have a defined waste management system in place to dispose of your disposables, and how important is that to Pfizer?
J Thompson: Most of the material we do is infectious material so our standard practice for disposing of plastics is to disinfect and then it goes to incineration. That’s how we’re handling plastics. I think Jerold Martin had some interesting ideas at IQPC in the past couple of years in terms of trying to recycle and recapture some of the energy in the plastics by trying to work out deals with companies that will incinerate it and use it for other types of recycled material. I believe the one in Germany he cites is maybe a car tyre manufacturer where they linked up with a plastics disposables site to recapture some of the value of the plastic, but the material we use is strictly incineration due to the infectious material we are trying to dispose of.
Pharma IQ: Do you have to worry about the effect incineration will have on the environment?
J Thompson: Absolutely, yes.
Pharma IQ: How do you counteract that?
J Thompson: The cost/benefit now is for the steel tank systems. To clean them you use caustic chemicals and then you have to wash them with huge amounts of water to clean out the caustic chemicals. Those caustic chemicals have to go somewhere in the environment too and then all the energy it takes to make this high quality water to rinse out your tanks; it costs a lot of money. When you do a net/net environment impact, even though you’re incinerating these the impact on the environment is less.
There are strict regulations on filters on incineration plants too in terms of decreasing any sort of environment exposure from the incineration. Again, it may be different for companies that are not using strictly infectious material; they may have better ways of handling it, it may not be such a critical item to have to incinerate and there may be better ways to recycle the plastics in some way.
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