The AAPS Journal

, Volume 18, Issue 4, pp 793–800 | Cite as

Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis

  • Anurag S. Rathore
  • Mili Pathak
  • Renu Jain
  • Gaurav Pratap Singh Jadaun


Monitoring the quality of pharmaceutical products is a global challenge, heightened by the implications of letting subquality drugs come to the market on public safety. Regulatory agencies do their due diligence at the time of approval as per their prescribed regulations. However, product quality needs to be monitored post-approval as well to ensure patient safety throughout the product life cycle. This is particularly complicated for biotechnology-based therapeutics where seemingly minor changes in process and/or raw material attributes have been shown to have a significant effect on clinical safety and efficacy of the product. This article provides a perspective on the topic of monitoring the quality of biotech therapeutics. In the backdrop of challenges faced by the regulatory agencies, the potential use of multivariate data analysis as a tool for effective monitoring has been proposed. Case studies using data from several insulin biosimilars have been used to illustrate the key concepts.


biosimilars multivariate data analysis process monitoring product quality quality by design 



ASR presently serves as the Chairman of the Committee for Advising the Drug Controller General of India on Regulation of Biotech Products. The approach stated in this article does not have any regulatory implications. The article presents merely a scientific perspective.


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Copyright information

© American Association of Pharmaceutical Scientists 2016

Authors and Affiliations

  • Anurag S. Rathore
    • 1
  • Mili Pathak
    • 1
  • Renu Jain
    • 2
  • Gaurav Pratap Singh Jadaun
    • 2
  1. 1.Department of Chemical EngineeringIndian Institute of TechnologyNew DelhiIndia
  2. 2.National Institute of BiologicalsNoidaIndia

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