Articles - Bioprocess Development Forum

Articles Downstream

March 1, 2018

Impurity Testing of Biologic Drug Products

Experts share insights on the various methods used for purity and impurity analysis of therapeutic...

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Articles BioPharma Downstream Regulatory

February 15, 2018

Preclinical Evaluation of Product Related Impurities and Variants

The approaches for sample preparation of preclinical evaluation of safety and efficacy are...

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Articles Regulatory

January 18, 2018

What’s in Your SOP?

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp...

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Articles BioPharma Regulatory

November 16, 2017

Evaluating Surface Cleanliness Using a Risk-Based Approach

Regulated companies that use automated cleaning applications have always struggled with correlating...

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Articles Downstream

November 2, 2017

Development of Purification for Challenging Fc-Fusion Proteins

Recent advances in mammalian cell culture processes have significantly increased product titers, but...

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Articles

October 5, 2017

Patenting Prospects for Cell-Based Therapies

Cell-based therapies are moving medical treatments forward, but intellectual property...

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Articles BioPharma Downstream Regulatory Upstream

September 21, 2017

Bioburden Control in the Biopharmaceutical Industry

The biopharmaceutical industry has witnessed tremendous breakthroughs during the past few years. However, this advancement...

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Articles BioPharma Downstream

September 21, 2017

Impact of Media Components on CQAs of Monoclonal Antibodies

Recombinant protein products have made a revolutionary impact on human healthcare by enabling mass...

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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 Regulatory

September 6, 2017

Avoiding Investigational Failures and Discrepancies

Investigations-focused regulatory standards that apply to life-sciences organizations, such as...

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