Regulatory - Bioprocess Development Forum

Articles Regulatory

October 10, 2016

Establishing Acceptance Criteria for Analytical Methods

To control the consistency and quality of pharmaceutical products, analytical methods must be...

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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 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 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 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 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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