quality-by-design - Bioprocess Development Forum

Articles Regulatory

June 2, 2022

e-Learning: what is quality by design (QbD)?

This free interactive course shares what quality by design (QbD) is all about. The focus…

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Articles BioPharma Downstream Regulatory Upstream

July 2, 2019

Addressing the Complex Nature of Downstream Processing with QbD

Regulators have been encouraging bio/pharmaceutical companies to incorporate the concept of...

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Articles BioPharma Regulatory

October 29, 2014

Continued Process Verification for Biopharma Manufacturing

Continued process verification (CPV) is the activity that provides ongoing verification of the...

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Articles BioPharma Downstream Regulatory Upstream

October 29, 2014

Application of Quality by Design to Viral Safety

The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the...

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Articles Regulatory

October 17, 2014

Using Quality by Design to Develop Robust Chromatographic Methods

The quality-by-design principles that enable a manufacturer to limit and control the sources of process…

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Articles BioPharma Regulatory

December 29, 2013

Quality by design for biotechnology products—part 1

Quality by Design (QbD) is a concept applied to the design and development...

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Articles

October 4, 2013

Essentials in Establishing and Using Design Space

Design-space generation always begins with CQAs, risk assessments, definition of materials...

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Articles BioPharma Downstream Upstream

August 5, 2013

QbD and PAT in Upstream and Downstream Processing

To gain perspective on the implementation of quality by design (QbD) and process analytical...

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Articles BioPharma Downstream Regulatory Upstream

July 5, 2013

Addressing the Challenges in Downstream Processing Today and Tomorrow

In recent years, most pharmaceutical companies have focused on the development of...

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Articles

June 22, 2013

Quality by Design: A CMO’s Perspective on Gaining Knowledge Faster and Better

From a CMO perspective, the traditional strategy behind process development has largely been to...

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