Process analytical technology (PAT) for biopharmaceutical products

• Published in: Analytical and bioanalytical chemistry 2010-09, Vol.398 (1), p.137-154
• Main Authors: Rathore, A. S, Bhambure, R, Ghare, V
• Format: Article
• Language: English
• Subjects: Analytical Chemistry; Biochemistry; Biological products; bioprocessing; Biotechnology - methods; Biotechnology - standards; Characterization and Evaluation of Materials; Chemistry; Chemistry and Materials Science; Drug Industry - standards; Evolution; Food Science; Humans; Laboratory Medicine; Mathematical analysis; Monitoring/Environmental Analysis; Monitors; Optimization; PAT; Pharmaceuticals; Process analytical technology, PAT; Production processes; Quality assurance; Quality by design; Quality Control; Real time; Rest; Review
• ISSN: 1618-2642; 1618-2650
• DOI: 10.1007/s00216-010-3781-x

The “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century—A Risk Based Approach” initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical technology (PAT) by the pharmaceutical industry. The potential for improved operational control and compliance resulting from continuous real-time quality assurance was highlighted as a likely benefit that would result from PAT implementation. A considerable amount of work has been done on this topic by academic and industrial contributors in the last decade. In this paper, we will start with a brief overview of evolution of PAT concepts and a review of their application in the wider pharmaceutical industry. The rest of the paper focuses on PAT applications for biotech processes with emphasis on developments in the last five years. It is our observation that while significant advances have been accomplished with regard to our ability to analyze/monitor key process and quality attributes in the biotech industry, much more needs to be done with regard to utilizing the collected data for subsequent control of the process, to achieve optimum yield and product quality. The latter is necessary to achieve the benefits that will result from PAT implementation. [graphic removed]