Articles - Bioprocess Development Forum

Articles BioPharma Downstream

September 21, 2017

Impact of Media Components on CQAs of Monoclonal Antibodies

Recombinant protein products have made a revolutionary impact on human healthcare by enabling mass...

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Articles BioPharma Downstream Regulatory Upstream

September 7, 2017

The Role of Quality Standards for Biomanufacturing Raw Materials

Successful pharmaceutical manufacturing strategies depend on raw materials that are of good quality.

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Articles Regulatory

September 6, 2017

Avoiding Investigational Failures and Discrepancies

Investigations-focused regulatory standards that apply to life-sciences organizations, such as...

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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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