The biopharmaceutical space is facing a
sea of change as new therapies enter the
market, necessitating more flexible forms
of manufacturing. From advanced therapy
medicinal products (ATMPs) to biosimilars, this transformation brings both opportunities and challenges to the industry.
Can Quality by Design (QbD) play a role
in addressing these challenges as innovative therapies come out of biopharma?
PDA Education instructor
PhD, President, BioPharmaceutical Quality Solutions, thinks so. He took some
time to explain to the
his upcoming course, “Quality by Design
(QbD) for Biopharmaceuticals,” scheduled before the 2nd PDA Europe Annual Meeting,
addresses the ways QbD can help
biopharmaceutical manufacturers in an
era of change.
What is QbD and is it still relevant?
QbD is a systematic risk- and science-
based approach to developing an effective control strategy. It was described
almost a decade ago in the ICH Q8–Q11
guidances. It is still an optional strategic approach even today, yet with the
challenging processes biopharmaceutical
manufacturers encounter, it can be tremendously rewarding, if not a necessity.
Through risk prioritization tools, limited
resources focus on the areas of control
with the greatest impact on product
safety and quality. By relying on sound
science, we gain an improved understanding of complex manufacturing processes,
which should result in fewer manufacturing deviations and batch failures.
Why was the course developed?
QbD has been embraced by both global
regulators and the larger biopharmaceutical companies. But many biopharmaceutical companies either have not yet
visualized, or have misunderstandings
about, the true value of QbD. This course
was developed to address these shortcomings, and to present a practical six-step approach to implementing the core principles of
Has this course
evolved over time
to reflect changes in
technology, particularly the growth
in biosimilars and
The core principles of
product profile (QTPP),
critical quality attributes
(CQAs), critical process
and control strategy
(CS)—are applicable to
manufacturing processes. Those involved in
recombinant protein and
manufacturing have well
embraced QbD, as evidenced by a quick look
at the public summaries
of these products being
approved for the marketplace today.
Biosimilar manufacturers also fully under-
stand the importance of QbD, especially
with the need to rapidly reverse-engineer
the manufacturing process of the innovator, and to adjust the CPPs to yield the
desired product-related substance and
product-related impurity CQA values
for the required analytical comparative
studies. Even those involved in advanced
therapies (i.e., gene and cell therapy
manufacturers) are beginning to realize
the value of QbD, as judged by the number of publications on this topic, as well
as by recent market-approved genetically
engineered viruses and genetically engineered cells that have incorporated QbD’s
What is one thing you hope students
will take away from this course?
My hope is that students leave with an
increased appreciation of QbD for all bio-
pharmaceutical manufacturing processes.
Yes, the investment in QbD takes place
during clinical development when the
product is at significant risk of not passing the threshold of the different clinical
stages, but investment in sound science
pays off in a fuller understanding of the
manufacturing process and its proper
control. I trust that the students will go
back to their respective companies with
Learn more about the PDA Education course, "Quality by Design for Biopharmaceuticals."