This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implementing it, and its current role in drug manufacturing.
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How as QbD evolved over the years?
Dr. Rathore: QbD is now in more mature state. The period of 2005-2008 was more about the industry and academia trying to understand what QbD is and what the underlying concepts meant. The years 2008-2012 were more about implementing QbD with the industry incorporating the various elements of QbD into its approaches of process and product development. This phase also included discussion between the industry and the regulatory agencies (particularly the U.S. FDA) about how to go about implementing QbD. The present phase (2012-ongoing) is more about refinement of QbD. Most major and mid-size biotech companies know what QbD means and how to go about implementing it and have already incorporated most of the QbD concepts into their approaches towards process and product development. Even biosimilar manufacturers based outside North America and Europe are also implementing QbD. But every company is in the process of trying to figure out better (as in more efficient with respect to resources and time) ways of implementing it. This is particularly true for biosimilar manufacturers for whom the economic drivers behind product development and commercialization are very different from the traditional innovators.
What trends can you identify in QbD?
Dr. Rathore: With respect to major trends, here are some that I see occurring at present. First is the industry’s interest in mechanistic modeling of biotech unit operations and the gradual move away from the traditional empirical models. Second is the focus on creating tools that can facilitate efficient QbD implementation. Examples of such tools include high throughput process development, computational fluid dynamics, and use of advanced statistical approaches for designing experiments, analyzing data, and process control. Third is increased focus on relating the quality attributes of a biotech product to its clinical safety and efficacy. Fourth is the extension of the QbD concepts from the traditional process development to analytical development and other key activities associated with the commercialization of biotech therapeutics.
How do you see the use of QbD evolving in the next five to ten years?
Dr. Rathore: QbD will continue to evolve over the next decade. New tools and approaches will be successfully developed. QbD implementation will become broader and more efficient. Different flavors of QbD will take shape to suite the diverse goals of conventional innovators and that of biosimilar producers. In brief, this will continue to be an area of interest for the industry, the academia, and the regulators.