QBD - Bioprocess Development Forum

Articles Regulatory

August 25, 2023

A risk based approach to sterile filtration

Drug quality cannot be assured only by finished-product testing. Process validation is required to...

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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 Downstream Upstream

March 12, 2020

Improving Upstream Predictability

In the earliest days of biotech, developers often struggled to sustain conditions that would...

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Multimedia

November 17, 2017

Handbook: Design of Experiments in Protein Production and Purification

Design of experiments (DoE) is a technique for planning experiments and analyzing the information...

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Articles BioPharma

April 19, 2017

Critical Quality Attributes Challenge Biologics Development

Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an...

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Articles BioPharma Upstream

February 26, 2015

Quality by Design and Extractable and Leachable Testing

Biopharmaceutical packaging performs several vital functions in assuring the drug product safety.

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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

June 13, 2014

Challenges in Analytical Method Development and Validation

The manufacture of biopharmaceuticals presents some unique challenges when ensuring...

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