Regulatory - Bioprocess Development Forum

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 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 Upstream

April 5, 2017

Single-use Bioreactors Have Reached the Big Time

Single-use bioreactors available from various vendors today are robust and provide the high-performance...

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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 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 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 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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