Upstream - Bioprocess Development Forum

Articles Downstream Regulatory Upstream

June 4, 2015

Host-Cell Protein Measurement and Control

Host-cell proteins (HCPs) constitute a major part of process-related impurities during biologics...

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Articles BioPharma Downstream Regulatory Upstream

April 8, 2015

Continuous Manufacturing: A Changing Processing Paradigm

Although continuous manufacturing is well established for bulk chemicals, complex automation and...

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Articles BioPharma Downstream Regulatory Upstream

April 6, 2015

Use of Multivariate Data Analysis in Bioprocessing

The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare...

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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 Upstream

December 3, 2014

Trends in Single-use Bioreactors

While the overall trend toward single-use bioreactors is generally positive, users continue to have...

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Articles Downstream Regulatory Upstream

November 1, 2014

Viral Clearance Challenges in Bioprocessing

Removal and inactivation of adventitious and endogenous viruses have traditionally been achieved...

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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 BioPharma Downstream Upstream

September 1, 2014

Challenges of Protein Aggregation During Purification

Removal of protein aggregates from biologic APIs is crucial due to their potential to increase...

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Articles Downstream Regulatory Upstream

January 13, 2014

PDA’s Technical Report for Biotech Cleaning Validation

Cleaning validation plays an important role in reducing the possibility of product contamination...

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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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