Articles by Anurag S. Rathore, PhD - BioPharm International

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Articles by Anurag S. Rathore, PhD

Setting Standards for Biotech Therapeutics in India

The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
Nov 1, 2014

The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.

Defining Critical Quality Attributes for mAb Therapeutic Products

An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
Jul 1, 2014

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

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.

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 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.

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.

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