BioPharma - Bioprocess Development Forum

Articles BioPharma Downstream Regulatory

September 27, 2018

Ensuring Viral Safety of Viral Vaccines and Vectors

Vaccines, including viral vaccines, are a crucial invention in human history and continue to...

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Articles BioPharma Downstream Upstream

July 2, 2018

Challenges in Cell Harvesting Prompt Enhancements

Cell harvesting is a crucial step that can have significant impact on product quality and…

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Articles BioPharma Downstream Regulatory

June 7, 2018

Putting Viral Clearance Capabilities to the Test

Drug products based on live cells have an inherent risk for viral contamination that could…

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Articles BioPharma Regulatory

April 12, 2018

Understanding Validation and Technical Transfer, Part I

Many new biological entities use unique processing flows and steps that can require non-traditional...

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Articles BioPharma Regulatory

March 1, 2018

Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins for purifying monoclonal antibodies and Fab fragments…

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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 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 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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