Building on the Scientific Foundation
With increasing numbers of bioprocessors taking PAT and QbD seriously, the future appears bright for bioprocess monitoring and advanced technologies for measuring quality attributes in real- or near-real time.
One hurdle to adoption of new process-monitoring technologies is the risk aversion of many biopharmaceutical companies, particularly with respect to highly regulated operations like cleaning and fermentation. But the FDA has made an effort, says Bader, to evaluate new techniques and technologies scientifically.
Regulators and companies alike, he says, are looking for favorable, substantiated precedents, preferably in already approved manufacturing processes. “Once they see a few case studies, see that people are doing it, and the technique has gone through regulatory approval, everyone is much more open.”