BioPharm International-11-01-2020

BioPharm International

Pinpointing Bioprocess Development Success

November 02, 2020

Cover Story

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More collaboration and a knowledge-based approach, driven by better analytics and high-throughput system integration, are reducing the risk of failure.

Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility Study

November 02, 2020

Peer-Reviewed Research

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Continuous SEC was shown to increase productivity with the same product quality and yield.

Control Strategies for Perfusion Cell Culture

November 02, 2020

Upstream Processing

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PAT advances are enabling improved process understanding, process control, and error prevention.

What’s New in Downstream Technologies

November 02, 2020

Downstream Processing

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The latest advances in downstream technologies include sterile disconnects for single-use manufacturing systems, ligand technologies for purifying RNA and for COVID-19 vaccines, and an automated perfusion system.

Single-Use Sensors Increase Process Understanding

November 01, 2020

Manufacturing

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The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Complex Manufacturing Processes Prompt New Inspection Methods

November 01, 2020

Quality/Regulations

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Complex manufacturing processes pose challenges for final product inspection needed to ensure product integrity at commercial launch.

Complex Modalities Require More Sensitive Adventitious Agent Testing

November 01, 2020

Analytics

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Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Digital Strategies for Biopharma Manufacturing

November 01, 2020

Operations

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Collecting and analyzing data are crucial for creating efficient, automated bioprocesses.

Bioprocess Scale-Up: Getting Smarter, Sooner

November 01, 2020

Outsourcing

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Single-use equipment, analytics, and automation may add complexity, but they are reducing scale-up costs and timelines.

COVID-19 Vaccine Distribution Raises Multiple Challenges

November 01, 2020

Regulatory Beat

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Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

Pandemic-fighting Drugs in Shortage, Again

November 01, 2020

From the Editor

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Resolving drug shortages starts with identifying the source of the problem.

Resuming Operations During a Pandemic

November 01, 2020

Ask The Expert

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Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.