“It’s hard to develop a new standard practice even within a single company, but across the industry it is even more difficult.” Kathryn McGohan, Associate Scientist II at Bristol-Myers Squibb, clearly understands the size of the task facing her and Ken Wong, Deputy Director at Sanofi Pasteur, in their quest to create a best practice guide for single use leachable studies. And yet, through their roles within the Biophorum Operations Group (BPOG), they have been working on a set of guidelines for risk assessment, leachable study design and leachable analytical methods. We spoke to them both to understand why and how they are doing it.
“Right now I don’t think the industry is using a standardised approach to leachable studies, which is why we have taken the effort to put out a best practice guide. When we started we did a survey of the companies involved and there is a lot of variation in how leachable studies are handled” explains McGohan, “Having a best practice in place will really help to drive a more consistent and robust approach.”
Both believe this is such an important issue, as they see single use technologies playing an important role in the bioprocessing industry over the coming years. “I expect to see single use continue to be more and more prevalent. There is a real desire for flexibility and efficiency that is provided by adoption of single use. Once we have figured out how we can quickly qualify and better understand the components, it will facilitate using more disposables within the process” says McGohan. Wong adds: “Beyond new implementation, we are going back to a lot of older systems to change and adopt single use technologies; modifying current systems and factories with single use into a hybrid system, which will be ramping up in the next five years.”
However, creating a universal set of guidelines has its fair share of challenges, even at the most basic level of agreeing what needs to be done. Different groups within the industry have varying questions and varying opinions on what is ‘best practice’ and “the lack of a clear and unified voice has hindered the progress of developing a widely accepted approach for all our manufacturers”.
Wong cites one example he has faced recently: “The peer companies have their own best practices and we have our own practices. This is mainly shaped by the fundamental differences stemmed from their own expertise, past experiences and regulators’ observations and questions over the years. We are trying to understand which ones are acceptable and whether our quality group can also accept the proposed best practices as well. It has become a very lengthy discussion just to iron out those differences in opinion.”
Indeed, even within single companies that are often spread across the globe, Wong emphasises that “the expectation in one continent is very different to another and we tend to take a more conservative approach on some sites than others”.
All these inevitable differences in opinion result in a continual compromise between BPOG’s member companies – a “give and take” as McGohan describes it. Wong adds that: “We have to deviate from what we think is the best practice or tailor our internal practices to be highly conservative in order to prevent future questions and observations from regulators.”
However, despite these challenges, Wong and McGohan are still making positive progress:
“We have been working on three sub-parts of the entire best practice – a risk assessment model, leachable study design, and analytical methods. As the initial step to get the ideas out there, these parts will be put together in preparation for publication. We will then open discussions with the regulators hopefully to understand what is acceptable and what the best path we can take is.” (Wong)
This step-by-step approach comes from a realisation that the process must be part of a wider discussion, as well as an understanding that the industry is never going to be totally standardised. Therefore, as McGohan explains, the “key to the guide is that it is flexible to allow companies to adapt it to their own strategies, while ensuring that key elements are considered”. After all, what use is a best practice guide if no one uses it?
Ken Wong is presenting the best practice guide – BPOG’s Best Practice Guide For Single Use Leachable Studies: Risk Assessment, Leachable Study Design and Leachable Test Method(s) – at 2.45pm and Kathryn McGohan is presenting at the BPI Interactive Theatre at 12.25pm on Tuesday 12th April 2016 at BioProcess International European Summit in Vienna. See the full agenda and register here.