BioPharm International-11-01-2019

BioPharm International

Biopharma modeling, now and five years from now

November 11, 2019

Upstream Processing

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Bob Lenich, Emerson's business director for global life sciences, shares insights on where biopharma modeling is now, and where it is heading in the near future.

What’s New in Manufacturing: Downstream Technologies

November 01, 2019

Downstream Processing

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The latest advances in downstream technologies include stainless-steel liquid chromatography columns, sensing and control units for hygienic valves, a wettable phase for separation and purification, a buffer delivery platform, and a new filter integrity tester.

More Consistent Drug Inspection System on Horizon

November 01, 2019

Regulatory Beat

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FDA readies more efficient oversight processes while advancing collaboration with Europe.

Signatures–What’s in a Name?

November 01, 2019

Ask the Expert

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It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

New Therapies Present Scaling Challenges

November 01, 2019

Cover Story

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Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The Principle of Scaling Down

November 01, 2019

Cover Story

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The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

Breaking the Drug Shortage Cycle

November 01, 2019

From the Editor

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FDA report says drug shortages are underappreciated and patients pay a price.

Essentials in Bioassay Development

November 01, 2019

Analytics

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Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.

Developments in the Biopharmaceutical Outsourcing Industry

November 01, 2019

Perspectives on Outsourcing

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Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.

BioPharm International, November 2019 Issue (PDF)

November 01, 2019

Issue PDF

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Click the title above to open the BioPharm International November 2019 issue in an interactive PDF format.