Roadmap for implementation of quality by design (QbD) for biotechnology products教程.pdfVIP

Review Roadmap for implementation of quality by design (QbD) for biotechnology products Anurag S. Rathore Department of Chemical Engineering, Indian Institute of Technology, New Delhi, India Quality by design (QbD) has been receiving a lot of comprising the key steps that need to be taken for success- attention in the pharmaceutical community of late. Suc- ful QbD implementation for a biotechnology product. cessful QbD implementation requires a thorough under- These steps are in alignment with recommendations in standing of the relationship between the critical quality the ICH guidance documents [3–5]. The approach involves attributes (CQAs) and the clinical properties of the pro- the following principles: identification of the product attri- duct, the relationship between the process and CQAs butes that are of significant importance to product safety and the variability in raw materials. This article presents and/or efficacy, such as a quality target product profile a roadmap for successful QbD implementation for thera- (QTPP) and critical quality attributes (CQAs) [6,7]; design peutic biotechnology products. The approach presented of the process to deliver these attributes; a robust control here is aligned with existing regulatory guidance docu- strategy to ensure consistent process performance; vali- ments. Key developments are reviewed and case studies dation and filing of the process, demonstrating the effec- are used to illustrate these concepts. It is concluded that tiveness of the control strategy; and finally, ongoing although several QbD concepts are being practiced by monitoring to ensure robust process performance over the biotechnology industry, successful dialogue and the life cyc