“We sense fear of the unknown… yes, the future may appear scary, but the future of our industry needs us to act now.” These are the words of Stefan Merkle, Senior Director Sterility Assurance at Janssen at last year’s Fill Finish Technologies to Reduce Drug Release Times event (FF18). While this comment was in relation to a discussion on whether to pursue in-line monitoring/real-time release (ILM/RTR) technologies, it is equally applicable to the fill finish environment as a whole.
The Fill Finish Phorum has recently embarked on a series of exciting and ambitious initiatives, exploring new technologies and processes to enhance the efficiency and speed of drug release.
One of the key steps the Phorum has taken was to look at technologies that are already available to the wider industrial sphere, but which the biopharmaceutical industry is not taking advantage of. Following a face-to-face meeting in March, these were gradually whittled down to a shortlist, with two areas emerging which the Phorum intends to take forward – robotics and ILM/RTR. “The group feels there is great value in using the Phorum in ‘consortium mode’ to lower the risks and associated costs of technology adoption,” said Dawood Dassu, Phorum Lead.
Other areas that the group has identified as requiring focus over the coming months are secondary packaging and highly active/toxics in a multi-product environment.
There has been a relatively slow take-up of robotics in the biopharmaceutical industry, particularly in fill finish, However, manufacturers are now coming to market with a variety of robots that can be used in this arena. The promise is that robotics means manufacturing becomes more agile, operations can be simplified, changeovers automated, accuracy improved and the need for human intervention, and hence errors, is removed, while the risk of contamination is greatly reduced.
Discussions have revealed that several organizations were already using robots in their fill finish areas. So now the group plans to survey their usage, understand the plans companies have for extending their usage, and collate the challenges people are facing in their operation or in justifying the spend. On the back of this, the group will look to revise the Small Flexible Filler User Requirements Specification (URS) composed in 2017/8 to include greater emphasis on robotics. This will involve significant collaboration with organizations which develop and manufacture this technology.
In-line monitoring/Real-time release (ILM/RTR)
Measuring the quality of a drug product (DP) during the manufacturing process is time-consuming involving stopping the flow of the process, taking a sample, testing it in a lab and waiting for the results. But if you can integrate this into the process a vial can effectively be cleared in real time.
Introducing ILM/RTR in fill finish is contentious, however. So, to flush out the pros and cons, an Oxford-style debate was held to discuss whether ILM could deliver adequate benefits to justify overcoming the barriers to adoption. Following a frank exchange of views, more than three-quarters of delegates (77%) voted in favor of pursuing the technology further. While the initiative is visionary, and faces multiple challenges, the consensus was that it is something that needs to happen although it is by no means a done deal.
“[At this stage], we’re not going all in… we’re making incremental progress – like an experienced poker player,” said Jason Vorhees, Principal Project Manager at Roche.
The group now plans to assemble a pathfinder group, which will use the process developed in the Technology Roadmapping Phorum to understand the required quality attributes and process control parameters in the DP process. The group will then perform a gap analysis to decide the best way to facilitate progress.
Working in a pathfinder team over the last two months, leaders and subject matter experts have agreed to work on the challenges of moving from large secondary packaging runs to small, higher value runs, including changeover times and line clearance; digital labeling and leaflets; and serialization.
Increasingly new DPs are niche, serving fewer patients, increasing production costs and making it critical to be good at short flexible runs. The scoping exercise will continue over the summer so that the group can confirm the key areas to progress and agree the outputs they want to achieve.
Highly actives/toxics in multi-product operations
Increasingly highly active and toxic niche market products are appearing in our product portfolios. This is a topic that was first discussed in the Phorum five years ago but now with the growth of the membership it is easier to find a critical mass of companies keen to share and collaborate on some of the challenges these products create in production facilities, such as how do we handle these highly active products in a multi-product environment and ensure cross-contamination is not possible? How do we best conduct changeovers? And how do we continue to protect operators? Have we got the most appropriate regulations and framework in place?
To answer these questions, the workstream is set to establish a pathfinder group to identify and scope potential areas of collaboration.
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