Articles - Bioprocess Development Forum

Articles BioPharma Downstream Upstream

August 11, 2017

Process Chromatography: Continuous Optimization

Cell-culture and fermentation are high-yielding processes that effectively produce...

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Articles BioPharma Regulatory

June 28, 2017

N-Glycan Analysis of Biotherapeutic Proteins

This article summarizes the approaches, challenges, and future perspectives for the characterization...

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Articles Downstream Regulatory Upstream

June 14, 2017

Managing Residual Impurities During Downstream Processing

Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.

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Articles BioPharma Downstream Regulatory

May 4, 2017

Being Thorough When Transferring Technology

Tech transfer and scale up of biologics can be as complicated as biologic therapies themselves.

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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 Downstream

April 19, 2017

Mechanistic Modeling of Preparative Ion-Exchange Chromatography

Among the various downstream processing unit operations that are used for purification of biotech...

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Articles Downstream Regulatory Upstream

April 19, 2017

Downstream Processing for Cell-Based Therapies

With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and...

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Articles BioPharma Downstream Regulatory Upstream

April 5, 2017

Single-use Bioreactors Have Reached the Big Time

Single-use bioreactors available from various vendors today are robust and provide the high-performance...

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Articles BioPharma

February 23, 2017

Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution

The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions...

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Articles BioPharma

February 23, 2017

Ensuring the Biological Integrity of Raw Materials

Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant...

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