BioPharma - Bioprocess Development Forum

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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Articles BioPharma Regulatory

August 31, 2016

Perfusion in the 21st Century

Cell-culture technology for biopharmaceutical manufacturing has steadily advanced over the past three...

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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 BioPharma

April 28, 2016

Platform Approach Speeds Process Development

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

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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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Articles BioPharma Regulatory

October 22, 2015

Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity

Biotherapeutic antibodies are still the largest growing class of medicines and are used globally...

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Articles BioPharma Downstream Regulatory Upstream

September 10, 2015

Best Practices in Qualification of Single-Use Systems

Single-use technology has been around for approximately two decades if disposable capsule filters...

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