Key Benefits of PAT and QBD Implementation

Brett Cooper Research Fellow, MSD Development Laboratories, talks to Pharma IQ, about the slower than anticipated industry uptake of PAT and QbD, the key benefits of PAT and QbD implementation and the biggest challenge pharma and bio companies face regarding the interpretation of regulatory guidance. Cooper also discusses how to prove the business case for PAT and QbD implementation. To listen to the interview in full Making a Business Case for PAT and QbD Implementation: .

Pharma IQ: The SPA driven PAT and QBD initiative was launched almost ten years ago but there still remains a substantial sector of the market that are not using PAT or QBD methods. Although companies undoubtedly have much better understanding of what QBD is we still do not see many initiatives taking place across the pharma industry. Why do you think the industry uptake has been slower than originally anticipated by the FDA?

Brett Cooper: I can think from the Merck point of view that I guess once the FDA announced the QBD initiatives and it started working on it almost straight away. And I think that Merck introduced QBD into one of its projects as part of the trial that was going ahead initially. QBD in that respect was sort of jumped into by Merck to some degree. Although I guess the big pharma companies such as Merck, there obviously is some degree of alignment that needs to take place before companies like that can implement QBD throughout a project and assess the impact of that. So I guess things like management position on taking a stance on the recommendations and then teams being formed to work out how we’re going to implement those sorts of procedures. And I guess the downstream training and implementation of those processes with the majority of staff in a large company will take time. And I guess at least on a Merck perspective we try to implement those processes as quickly as possible. And then there’s also the impact of the development time lines that need to be considered. So if you start with a new project and start implementing QBD those projects can take considerable time to get to the market or get to review by the FDA.
Pharma IQ: And what do you think is the biggest challenge pharma and bio companies face with regard to interpretation of regulatory guidance?

Brett Cooper: In terms of regulatory guidance I guess that their challenge would be more around the resource to investigate that because a lot of those companies will be smaller. For pharma and bio companies especially, reading into the guidelines and determining how to understand those may be more problematic for the smaller companies. But the larger companies I guess coming to an agreement and discussing the guidance with the regulatory authorities is another thing that needs to occur. Sometimes I guess the big industries, when we come to follow the guidances and present those in a filing there can often be some aspects which are seen as different by the FDA. It depends on how the interpretation is set.
Pharma IQ:And what are the key benefits of PAT and QBD implementation?

Brett Cooper:QBD obviously is designed to give you the flexibility to change downstream. So if you can demonstrate that you have a wide working margin then you can maybe find ways to optimise and improve your process downstream while remaining within the QBD space that you’ve designed. PAT is a pretty powerful tool and if you link that with your processing machinery then you can actually monitor the process. Maybe come up with real time release of the process to cut down on the amount of testing downstream and also really link the PAT with the process to ensure the quality of the material is optimised at the end.

Pharma IQ:How do you think companies can improve the business case for PAT and QBD implementation?

Brett Cooper:I guess by trial and implementation of those processes and then evaluating how those processes have gone. I guess the bigger companies where when you have multiple projects going forward and you start implementing your PAT and QBD processes and you start comparing those with prior processes you can sort of track how things are going and how the costs can be potentially reduced. Some procedures where you implement QBD strategies or designs or procedures that are already in place where there are maybe some issues or batches that potentially aren’t processing so well, you can almost see an immediate change if you track the processes during the manufacture. So there’s sometimes an immediate win by implementing those processes that can be achieved.

Pharma IQ:I understand that you’re going to be speaking at the 9th Annual PAT and Quality by Design conference taking place from the 20th to the 22nd of February in London. What are you most looking forward to about the conference?

Brett Cooper:The part I’m looking forward to most is looking and talking to the other companies, seeing their presentations and seeing how they perform their PAT procedures and QBD initiatives. And sort of seeing how they compare with ours and where there are similarities and where there are potentially areas for improvement and that we can potentially bring back into our company. Implement some of those procedures moving forward.

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Interview conducted by Andrea Charles.


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