QbD's future in biologics
Looking ahead, certain technologies and processes will need to be refined for QbD implementation in the biopharmaceutical
As noted, QbD implementation requires extensive process and product knowledge (6, 7). Acquiring this level of understanding
requires extensive experimentation. In the current environment, where cost needs to be controlled, use of high-throughput
tools and approaches has emerged as a means of saving considerable costs on needed chemicals, feed material, product, equipment,
and most importantly, staff (11). There is a strong likelihood that widespread use of high-throughput tools and approaches
will dramatically change how the biotech industry performs the various activities required for product and process development
and commercialization in the next decade.
Nonclinical studies as predictors of safety and/or efficacy.
Industry at present relies heavily on clinical studies to assess drug safety and efficacy. Although advances have been made
in the past decade with regard to industry's ability to model safety and/or efficacy through nonclinical studies, more is
needed to reduce reliance on human clinical trials (10). Developments in the way drugs are discovered and in molecular design
Use of statistical approaches and risk management.
QbD implementation requires extensive information about the product and its manufacturing process. However, in view of the
large number of variables and attributes that interplay to impact safety and efficacy of a biotechnology product, it is not
possible to evaluate the effect of every variable. Statistical approaches, such as design of experiments (DOE) and multivariate
data analysis (MVDA), along with risk management tools such as the Failure Modes and Effects and Analysis (FMEA), can help
to ensure that resources are spent on the most important tasks.
Thus far, QbD implementation has been limited to large and mid-size biotechnology companies in the US and the Europe. As
manufactures based in India and China start producing follow-on biologics for the European and the US markets, they too will
start imbibing QbD principles. Some of these companies have already started this alignment. In the near future, the biotechnology
industry is likely to see a major overhaul of scientific and quality-based manufacturing approaches as well as a more global
adoption of QbD principles.