Novo Nordisk’s broad-reaching quality-by-design (QbD) initiative for protein development is gaining traction faster than the company had anticipated, fueled by buy-in from top management and the production department.
Discussing the steps his company has taken to implement QbD across its protein product and process development operations at ISPE’s Washington Conference in early June, Novo Nordisk (NN) Senior QbD Manager Michael Schousboe noted the enthusiastic uptake the program has gotten. “It has really spread a lot faster than we originally anticipated” and now has “very high management buy in,” he reported at the ISPE conference’s Product Quality Lifecycle Implementation (PQLI) track.
NN has developed a workable model for implementing QbD as a “strategic initiative” encompassing its quality, CMC and production departments, Schousboe said, and the effort has been “ramped up” based on the positive experience gained. He highlighted the strong “push” coming from the production unit, in particular, as the impact on process efficiency and capability becomes clearer.
The “picture from an implementation project point of view is sort of ideal,” the QbD project manager noted – “having a lot of customers screaming for what you are trying to sell.”
Subscribers can read more about Novo Nordisk’s QbD initiative on p. 2.
Note: The May issue of IPQ provides an in-depth report on the impact of the QbD/ICH Q8-10 paradigm is having on the CMC review process in the U.S., Europe and globally.
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