Operations Excellence - BioPharm International

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Operations Excellence

Operational Excellence: More Data or Smarter Approach?

June 1, 2011

The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.

Achieving Process Intensification by Scheduling and Debottlenecking Biotech Processes

February 1, 2011

An approach to reduce batch time, increase productivity, and decrease costs.

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

December 1, 2010

Evaluate and communicate risk to stakeholders.

Getting Better at Making Stuff

December 1, 2010

To achieve manufacturing excellence, biopharma companies must adopt four key operating principles.

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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