Regulatory - Bioprocess Development Forum

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 Regulatory

March 13, 2018

Applying GMPs in Stages of Development

Regardless of the phase of development and the level of GMPs being applied, there should…

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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 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 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 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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