Articles by Anurag S. Rathore, PhD - BioPharm International

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Articles by Anurag S. Rathore, PhD

Anurag S. Rathore, PhD


Anurag S. Rathore, PhD, is a consultant, Biotech CMC Issues, and a member of the faculty in the department of chemical engineering at the Indian Institute of Technology. Rathore is also a member of BioPharm International's Editorial Advisory Board.

Articles
Defining Critical Quality Attributes for mAb Therapeutic Products
July 1, 2014

Establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.

Process Lifecycle Validation: Applying Risk Management
August 1, 2013

The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.

Aggregation of Monoclonal Antibody Products: Formation and Removal
March 1, 2013

Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.

Managing Raw Materials in the QbD Paradigm, Part 2: Risk Assessment and Communication
December 1, 2010

Evaluate and communicate risk to stakeholders.

Managing Raw Materials in the QbD Paradigm, Part 1: Understanding Risks
November 1, 2010

Adequate characterization of materials protects product quality.

Setting Specs for a Biotech Therapeutic Product in the QbD Paradigm
January 1, 2010

Key considerations for defining your overall control strategy.

Quality by Design for Biotechnology Products—Part 3
January 1, 2010

Regulatory flexibility can make continuous improvement possible.

Quality by Design for Biotechnology Products—Part 2
December 1, 2009

Second in a three-part series that discusses the complexities of QbD implementation in biotech development.

Quality by Design for Biotechnology Products—Part 1
November 1, 2009

First in a three-part series that discusses the complexities of QbD implementation in biotech product development.

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