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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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Articles Regulatory

August 13, 2015

Cleaning of Dedicated Equipment: Why Validation is Needed

Cleaning of pharmaceutical equipment is essential to reduce the risk of product contamination and...

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Articles Downstream

August 13, 2015

Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification

An important area of focus for the biopharma industry is the elucidation and development of...

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Articles BioPharma BioPharma Q&A Regulatory Regulatory

July 15, 2015

Risk Assessment and Mitigation in Biopharmaceutical Manufacturing

BioPharm International spoke with Stephan Krause, director of quality assurance, Laura Jeannel...

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Articles BioPharma Regulatory

July 15, 2015

Robust Optimization, Simulation, and Effective Design Space

Developing product knowledge and process understanding is at the heart of modern drug...

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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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