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Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis

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Abstract

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.

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Disclaimer

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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Authors and Affiliations

  1. Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi, 110016, India

    Anurag S. Rathore & Mili Pathak

  2. National Institute of Biologicals, Noida, India

    Renu Jain & Gaurav Pratap Singh Jadaun

Authors
  1. Anurag S. Rathore
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  2. Mili Pathak
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  3. Renu Jain
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  4. Gaurav Pratap Singh Jadaun
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Correspondence to Anurag S. Rathore.

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Rathore, A.S., Pathak, M., Jain, R. et al. Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis. AAPS J 18, 793–800 (2016). https://doi.org/10.1208/s12248-016-9908-z

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