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 John Geigert, PhD, President, BioPharmaceutical Quality Solutions, thinks so. He took some time to explain to the PDA Letter how his upcoming course, “Quality by Design (QbD) for Biopharmaceuticals,” scheduled before the 2^nd 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 QbD.

Has this course evolved over time to reflect changes in technology, particularly the growth in biosimilars and advanced therapies?

The core principles of QbD—quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs), and control strategy (CS)—are applicable to all biopharmaceutical manufacturing processes. Those involved in recombinant protein and monoclonal antibody 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 core principles.

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 this message.

Learn more about the PDA Education course, "Quality by Design for Biopharmaceuticals."