Articles - Bioprocess Development Forum

Articles BioPharma Regulatory

August 16, 2016

Design and Qualification of Single-Use Systems

Single-use technologies (SUT) have made significant inroads in biopharmaceutical and vaccine...

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Articles Downstream Regulatory Upstream

May 25, 2016

An Integrated Approach to Ensure the Viral Safety of Biotherapeutics

Use of continuous cell lines in the manufacture of biological therapeutic products, such as...

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Articles Regulatory

May 12, 2016

A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media

Cell-culture media are essential raw materials that are required for the manufacture of...

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Articles BioPharma

April 28, 2016

Platform Approach Speeds Process Development

Commercial production of complex biopharmaceuticals such as recombinant monoclonal...

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Articles Downstream Regulatory Upstream

April 14, 2016

Continuous Processing for the Production of Biopharmaceuticals

The biosimilars landscape is growing as market factors, such as pricing pressure, advanced...

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Articles

March 30, 2016

A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications

The Chinese hamster ovary (CHO) cell lines used for the production of recombinant therapeutic proteins...

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Articles Downstream Regulatory Upstream

March 16, 2016

Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge

The necessity to detach cells from a culture substrate during cell harvesting remains one of…

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Articles BioPharma Upstream

February 18, 2016

Antibody Production in Microbial Hosts

The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs)…

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Articles BioPharma Downstream Upstream

January 21, 2016

Going Small to Achieve Success on the Commercial Scale

Biopharmaceutical manufacturing involves a series of complex unit operations linked together to...

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Articles BioPharma Downstream Regulatory Upstream

November 19, 2015

Selecting the Right Viral Clearance Technology

The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug...

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