Articles by Anurag S. Rathore, PhD

Quality by Design for Biotechnology Products—Part 1

A PhRMA Working Group's advice on applying QbD to biotech.
Nov 1, 2009
By:Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta, Stefanie Pluschkell, Mark Rosolowsky, Anurag S. Rathore, PhD, Mark Schenerman, Tim Schofield, Samantha Sheridan, Paul Smock, Sally Anliker, Lois Atkins, Bernerd McGarvey, Bruce Meiklejohn, Jim Precup, John Towns

A PhRMA Working Group's advice on applying QbD to biotech

Analytical Tools for Process and Product Characterization

Select the best approach to determine critical quality attributes.
Aug 1, 2009
By:Brent S. Kendrick, PhD, Greg Chrimes, Steven L. Cockrill, PhD, Kelly K. Arthur, Brad D. Prater, Qiang Qin, PhD, Bing Zhang, Anurag S. Rathore, PhD, John P. Gabrielson

Select the best approach to determine critical quality attributes.

Best Practices for Formulation and Manufacturing of Biotech Drug Products

How to maintain product stability and prevent particulates.
Jun 1, 2009
By:Satish K. Singh, Nitin Rathore, Arnold McAuley, Anurag S. Rathore, PhD

How to maintain product stability and prevent particulates.

Monitoring of Biopharmaceutical Processes: Present and Future Approaches

Enhance your control strategy with robust monitoring methods.
May 1, 2009
By:Paul Konold, Rob Woolfenden II, Cenk Undey, Anurag S. Rathore, PhD

This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.

Upcoming Technologies to Facilitate More Efficient Biologics Manufacturing

Choosing the right tools to enhance the process.
Feb 1, 2009
By:Xuemin Liu, Mike Collins, Nathalie Fraud, Jennifer Campbell, Inese Lowenstein, Karol M. Lacki, Anurag S. Rathore, PhD

Choosing the right tools to enhance the process.

QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes (Part 2)

Understanding the relationship between the process and CQAs.
Jan 1, 2009
By:Anurag S. Rathore, PhD, Azita Saleki-Gerhardt, Stephen H. Montgomery, Stephen M. Tyler

Understanding the relationship between the process and CQAs.

QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1

How to use multivariate experiments to define acceptable ranges.
Dec 1, 2008
By:Anurag S. Rathore, PhD, Azita Saleki-Gerhardt, Stephen H. Montgomery, Stephen M. Tyler

Using multivariate experiments to define acceptable ranges.

Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit Operation

How to apply the latest thinking in process modeling to your process using a Quality by Design approach.
Aug 1, 2008
By:Oliver Kaltenbrunner, Justin McCue, Philip Engel, Jorgen M. Mollerup, Anurag S. Rathore, PhD

A review of some recent contributions in process chromatography.

Modeling of Biopharmaceutical Processes—Part 1: Microbial and Mammalian Unit Operations

Process-modeling tools can ensure smooth technology transfer of microbial and mammalian processes from bench to commercial scale.
Jun 1, 2008
By:Anurag S. Rathore, PhD, Ken Green, Yas Hashimura, Greg Nyberg

Process-modeling tools can ensure smooth tech transfer.

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