QbD and PAT

There was no appreciable change over last year in the number of respondents reporting that their companies incorporate quality-by-design (QbD) principles into their operations—65% this year versus 67% last. Nor is there a significant difference over last year in the percentages of respondents who say QbD helps to improve their process understanding (69%), manufacturing efficiency (50%), and improved product quality (49%), while reducing variability (47%). Among those who do not incorporate QbD into their processes, 42% say they lack sufficient guidance from regulatory agencies, 25% say they don't understand the initiative, and 23% don't see any advantages to be gained. Finally, 21% say QbD is too costly. Companies with revenues above $1 billion are more likely to incorporate QbD than are smaller companies—with 92% of respondents in companies with revenues between $10 billion and $50 billion, and 100% of respondents in companies with revenues above $50 billion saying they incorporate QbD. In contrast, only 50% of respondents in companies with revenues under $500 million say they do. Respondents in smaller companies are less likely to understand the initiative and more likely to find it too costly than are their counterparts in companies with larger revenues.

While 65% of respondents say they incorporate QbD into their manufacturing operations, only 44% say they incorporate process analytical technology (PAT), although here there is a dramatic difference between larger and smaller companies. Fewer than 60% of respondents from companies with revenues below $5 billion say they incorporate PAT, whereas more than 70% of respondents from companies with revenues higher than $5 billion say they do. High performance liquid chromatography (HPLC) is far and away the most frequently employed analytical technology, with 69% of respondents saying they use it. That's followed by 31% each who say they use disposable sensors and Fourier-transform infrared spectroscopy (FT-IR).

As the economy comes out of the recession, the hope among equipment manufacturers is that customers will increase their spending in 2011, compared with 2010. Will they? Interestingly, only 26% say they plan on increasing their equipment purchases this year over last (down from 31% who made that prediction last year—a very accurate prediction, since exactly that percentage report that they did in fact increase their spending levels in 2010 over 2009 levels). Another 36% say they expect spending levels in 2011 to remain the same as 2010, and 13% (down from last year's 15%) say they expect to decrease their spending levels.

Innovation

Finally, we asked respondents to tell us what innovations would improve their process efficiency and/or product quality. This year, respondents hoped for better automation, better control of post-translational modifications and analytics that can discern small variations in protein composition (in real time) and in cell metabolism. Others hoped for more streamlined purification processes and an alternative to Protein A.