The Potential for Implementing Quality By Design in Biomanufacturing

By Nick Hutchinson

If quality by design (QbD) promises a more efficient manufacturing process in which product quality and safety are a given, why is there reluctance among the industry to adopt the approach? A survey conducted at Cell Culture Engineering XIV in 2014 shed some light on both the industry’s concerns and engagement levels by offering an overall conclusion that while some of the industry is in the process of adopting the QbD methodology, many are struggling to understand the expectations of the regulators.

Respondents, who were primarily from research and development functions, offered several reasons to explain their hesitation. Approximately half of those surveyed described “unclear or inconsistent regulatory expectations” as being the biggest obstacle to implementation. Another major obstacle for 26% of respondents...