Regulatory - Bioprocess Development Forum

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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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

May 4, 2017

Being Thorough When Transferring Technology

Tech transfer and scale up of biologics can be as complicated as biologic therapies themselves.

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Articles Downstream Regulatory Upstream

April 19, 2017

Downstream Processing for Cell-Based Therapies

With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and...

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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 Downstream Regulatory Upstream

November 10, 2016

Improving Process-Scale Chromatography

Chromatography is a crucial step in the purification of biopharmaceuticals and accounts for a...

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