Laura Bush
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Colleagues from other departments in my company sometimes ask what topics are hot in the field I cover. My answer always seems
to start with, "Many of the same things that have been hot for the past four or five years . . ." As those who work in this
area know, the science and regulation of drug manufacturing don't change very fast.
The evolution of Quality by Design is no exception. The concept was born in 2002 with the US FDA's twenty-first century initiative.
As we now enter the second decade of the new century, QbD seems to be coming out of early childhood and entering that difficult
transition into adolescence.
We could look at QbD's plodding growth and conclude that it is never going to make it to graduation. I prefer to see the last
eight years, however, as a necessary development process. We may think that our kids should grow up faster than they do (who
hasn't wished that a teenager would act more mature?). But as we all know, wishing won't make that happen.
The same holds true for a concept as big as this one. Yet, we have seen important progress. Industry now seems fairly comfortable
with certain core aspects of QbD, particularly in terms of what it means to carry out product and process development in a
QbD framework—what studies to carry out, how to determine critical quality attributes (starting from the patient's needs),
how to take advantage of design of experiments (DOE), even how to develop a design space.
This understanding has resulted from intensive work—within company walls, and through cross-company collaboration and industry–regulator
dialogue—and has laid the foundations for the next phase in QbD's development. In that next stage, several big challenges
remain to be sorted out, including:
1. How to file. How do you clearly demonstrate your product and process understanding? How much information should you provide?
2. Lifecycle management. How will process validation, change control, deviations, and inspections be managed in a QbD environment? How will regulatory
commitments be defined? How much flexibility will companies have to make postapproval changes without regulatory filings?
(See my January editorial).
We are now at an exciting juncture for QbD. The QbD Working Group of the PhRMA Biologics and Biotechnology Leadership Committee
has published its white paper, the CMC Biotech Working Group has released its 278-page A-MAb case study, and EFPIA is progressing
on its mock CTD S2 and P2 filings. These groups have approached the goal of advancing QbD from different angles, and thus
are contributing to the overall effort in complementary ways. Meanwhile, of course, two major regulatory efforts also are
underway—ICH Q11 on applying QbD to biologics and the FDA QbD pilot for biologics.
In the coming year or two, through public workshops and meetings, the industry and regulators will begin, collectively, to
digest all the recent efforts and start to figure out how to take the next steps forward, particularly on the tricky pending
issues mentioned above. And I am confident that from all this effort, will we see important progress toward getting QbD out
of school and into the real world.
P.S. Learn more about the latest in thinking on QbD through our new podcasts and webcasts. On our web site, click on the podcast
and webcast links.
Laura Bush is the editor in chief of BioPharm International, lbush@advanstar.com
