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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Indian Institute of Technology Delhi
Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi, Tel. +91.9650770650, firstname.lastname@example.org.
May 15, 2019
This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
November 01, 2012
In this paper, the authors review the various analytical methods that can enable use of PAT.
March 02, 2011
The author provides an overview of QbD implmentation for biopharmaceuticals.
February 01, 2010
References for the article published in the February issue of Pharmaceutical Technology Europe.
April 01, 2009
The number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.
July 01, 2006
Constraints associated with equipment can make scale-down a challenging exercise.