Articles by Anurag S. Rathore, PhD - BioPharm International

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Articles by Anurag S. Rathore, PhD

Process Lifecycle Validation: Applying Risk Management

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

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

Evaluate and communicate risk to stakeholders.
Dec 1, 2010

Evaluate and communicate risk to stakeholders.

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

An initial assessment of materials must extend beyond the material specification to include the supplier's manufacturing process, quality systems, and sourcing strategy.
Nov 1, 2010

Adequate characterization of materials protects product quality.

Quality by Design for Biotechnology Products—Part 3

Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals.
Jan 1, 2010

Regulatory flexibility can make continuous improvement possible.

Setting Specs for a Biotech Therapeutic Product in the QbD Paradigm

Manufacturing using meaningful, science-based specifications will ensure that we attain the optimal balance between manufacturing flexibility and product safety.
Jan 1, 2010

Key considerations for defining your overall control strategy.

Quality by Design for Biotechnology Products—Part 2

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

A PhRMA Working Group's advice on applying QbD to biotech.
Nov 1, 2009

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

Analytical Tools for Process and Product Characterization

Select the best approach to determine critical quality attributes.
Aug 1, 2009

Select the best approach to determine critical quality attributes.

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