Implementation of Quality by Design for processing of food products and biotherapeutics

Abstract

It has been more than a decade since the concept of Quality by Design (QbD) was introduced to the biotech industry. Considerable efforts have been spent by the major regulatory agencies as well as the biotech industry in first creating a roadmap for implementation of QbD and then on achieving a consensus on what comprises a regulatory filing. The success of this effort is marked by the recent regulatory approval of the first QbD filing by the United States Food & Drug Administration (US FDA). Implementation of QbD has been somewhat differently paced in the field of food processing. This is likely due to the significant difference in the regulatory oversight in the two areas, albeit both fall under biotech processing and are governed by the same regulatory agencies. This article aims to achieve two major objectives. First, review the progress that has been made in the recent years on the topic of QbD implementation in processing of food products and biotherapeutics (2010–2015). Second, present case studies to introduce novel technologies and approaches that have the potential of facilitating wide implementation of QbD.