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Biopharmaceutical Manufacturing Efficiency – Are We There Yet?

Over the past decade or so, the biopharmaceutical industry has placed a greater emphasis on overall manufacturing efficiency and, judging from company publications and presentations on this topic, gains have been made. These gains have come both from implementation of technologies that improve efficiency, such as single-use processing technologies, as well as from operational efficiency initiatives that are geared towards simply improving the way we operate existing manufacturing facilities. To help judge where we are on the “learning and adoption curve” and to gauge how important these initiatives are industry-wide, BPTC recently conducted a BioPulse survey on the topic of Manufacturing Efficiency.

The vast majority of respondents felt that we made significant progress in improving manufacturing efficiency but more work still remains. Consistent with the opportunity for more improvement in this area, survey respondents reported a variety of ongoing initiatives within their organizations focused on overall improvements in disposables (28%), process analytical technologies [PAT] (26%), automation (23%), and supply chain management (21%). One area highlighted by respondents for improvement was the communications of the gains derived from existing initiatives – both within companies and to the outside world.

As the biopharmaceutical industry matures, improving manufacturing efficiency is taking on increasing importance. Among the survey participants, 75% ranked manufacturing costs and efficiency as important or very important in CMO selection, whereas only 13% felt that these were relatively unimportant. In addition to cost savings, increasing speed to clinic/market was identified as a primary objective for efficiency initiatives. Despite having increased importance and visibility, there is also recognition that some things are still more important. For example, the vast majority of respondents felt that risks and costs associated with failure to supply the market need to be considered when implementing manufacturing efficiency initiatives. Finally, new technologies were recognized as an important area for future gains in manufacturing efficiency, with disposables/single-use processing equipment (33%) and continuous processing (27%) identified as the technologies most likely to affect manufacturing efficiency.

While much remains to be done and we are sure that important gains in manufacturing efficiency are still ahead of us, we are at least encouraged that as an industry we are on the right path and starting to make progress. We expect to see continued investment in technologies and initiatives in this area.

 

Blog article by: Tom Ransohoff