By Sheila Magil (smagilbptccom)
In the biopharmaceutical industry, the adoption rate of Quality by Design (QbD) is perceived to be quite low. In a recent bioPULSETM survey, BPTC attempted determine if this assessment is a true reflection of industry QbD adoption rates or a simply a widespread misperception. According to the survey results, 80% of the respondents have used QbD at least once and in fact, only 5% indicated that QbD was irrelevant for biopharmaceutical development. It was apparent that while many individuals seem willing to try QbD, few utilize it routinely with less than one third (29%) of participants indicating that QbD was a routine part of their approach to biopharmaceutical development. These results did not vary by development area. With the exception of tech transfer (3%), use of QbD was fairly evenly distributed (14-23%) among all development and scale-up groups.
Approximately 70% of the survey respondents do not use QbD routinely, which may be due, in part, to confusion or uncertainty about the application and implementation of QbD. Half of the respondents indicated that the best way to learn about QbD is through structured training; however, only 5% indicated that their “go-to” resource is a formal course. While lack of support by senior management is another reason commonly cited as the cause for the poor adoption rate of QbD this reason was not supported in the survey as only 7% indicated that lack of management support was the reason they weren’t using QbD routinely.
Survey participants also expressed the concern that adoption of QbD in biopharmaceutical development could increase the development cycle and delay regulatory filing acceptance. Twenty percent of the respondents indicated that use of QbD requires more time and/or resources and an additional 13% saw no advantage to using QbD. Fifteen percent believe QbD adoption would delay regulatory approval and only 26% believe it would expedite product approval. These results are surprising in light of FDA’s statements that a QbD approach doesn’t change regulatory requirements but may provide the opportunity for a more flexible regulatory approach. The apparent confusion about the utility of QbD, however, did not result in rejection of a QbD development approach as 75% of the responses endorsed increasing the use of QbD in biopharmaceutical development.
Several recent discussions on LinkedIn have made it abundantly clear that the application of QbD to biopharmaceutical development begins with understanding what QbD really is. In retrospect, perhaps we should have asked survey participants to define QbD. Perhaps the real question is not, “Why is the biopharmaceutical industry slow to adopt QbD?” but rather, “What is QbD?”