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The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
The concept of end-to-end adoption of modeling and simulation tools for biopharmaceuticals process development is still seen with mixed views across industry professionals. The lack of standard analytics frameworks leads to suboptimal output and limits their widespread applicability. Additionally, the business impact of these tools is poorly understood because of the dearth of case studies on them. In this article, the authors present a business case study to investigate the returns from these tools. The authors also extrapolate the benefits to the overall drug development timelines and portfolio for the biosimilars industry.
Submitted: Jan. 25, 2022.
Accepted: March 22, 2022.
Mili Pathak*, PhD, firstname.lastname@example.org, is principal scientist, Process Science, R&D; Prashant Pokhriyal is associate scientist, Process Science, R&D; Ronak Patel is principal scientist, R&D; and Laxmi Adhikary, PhD, is senior vice-president, R&D; all at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India.
*To whom all correspondence should be addressed.
Vol. 35, No. 7
When referring to this article, please cite it as M. Pathak, et al., “Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?” BioPharm International 35 (7) 36–40 (2022).