Biopharma wary of disposable systems for large-scale production... for now
At the 13th Annual Biological Production Forum in Dublin, Ireland earlier this month, Pfizer spoke frankly about its difficulties in using disposable technology at its nearby Grange Castle commercial biologics facility, with price being a deciding factor.
A poll undertaken by Aspen Brook Consulting shows about 50% of respondents agree with Pfizer that the high price of single-use technology is limiting its adoption for high volume production, so Biopharma-Reporter.com spoke to Janssen, Eli Lilly and Merck & Co. during a tour of Ireland to find out how they utilise single-use technology.
Janssen’s commercial plants at its biologics manufacturing site in Cork, Ireland, use - according to General Manager Janssen Supply Chain Ireland Kyran Johnson - a hybrid approach, similar to its other biomanufacturing facilities worldwide.
“We ended up with reactors that are stainless steel because in our cell culture process we use a perfusion process that runs for 60 days,” he told us. “But everything feeding to and from the reactors uses single-use disposable technology. We make the media up in tanks, we make the buffer in tanks but we store in bags, we collect the harvest in bags and all the buffer systems are single-use.”
Eli Lilly also told this publication that its manufacturing complex in nearby Kinsale uses a mixture of technologies, but for its new onsite €330m ($450m) commercial plant – scheduled to be completed by the end of the year – it would use entirely stainless steel systems, mainly due to the need for large-scale production.
Single-use’s deficiency to be used for large volumes was also discussed by Brendan O’Callaghan, VP of biologics at MSD (known as Merck & Co. in North America), who told us scale is holding back MSD’s application of single-use but it was keeping an eye on the technology for future production.
He said single-use was becoming more prevalent, but not dominant in the industry, and MSD’s microbial fermentation plant in Brinny, Cork site uses 40,000L stainless steel fermenters. “Clearly single-use hasn’t quite got to that scale.”
He continued: “We actually use quite a range of single-use technologies and something we’re looking at actively in Merck right now is what our future platform will be for biomanufacturing.”
Standardisation & Collaboration
MSD’s idea that single-use will be integral in ‘the facility of the future’ is shared with Pfizer, but Janssen’s Johnson said more standardisation was needed before this could happen.
“When you go to different vendors there are no standards. They can use different film material which raises a whole load of issues with leachables and extractables,” he said. “We might have qualified our product on certain plastic materials and then we find that the source of that material might have animal origins, then we have a bigger concern.”
This is being exacerbated by many material makers being bought up by bigger companies, he continued, “so the ownership and controls are all over the place. This is perfect from an R&D perspective but we have a bit to go yet to make sure we have very robust systems in place until it becomes attractive from a commercial perspective.”
He continued: “We’re actually doing a lot of work in this space as an industry collaboratively, through the various industry groups. But we’re trying to work with the disposables groups (vendors) and we need standards in place.”