BioPharm International, September 2021 Issue

Setting a Clear Strategy for Primary Packaging

September 02, 2021

Cover Story

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Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

Conformational and Colloidal Stability Studies to Predict the Best Biopharmaceutical Formulation

September 02, 2021

Peer-Reviewed Research

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Establishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.

Bioprocessing Innovations Pose New Challenges for Fermentation

September 02, 2021

Upstream Processing

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Advancements in bioprocessing technologies test microbial fermentation adaptability.

Process Chromatography Makes Steady Progress

September 01, 2021

Downstream Processing

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Process chromatography in downstream processing has seen steady improvements over the years, but there is still room for improvement.

Reevaluating Cell and Gene Therapy Development

September 01, 2021

Development

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The industry considers applying automation and digitalization lessons learned during the COVID-19 pandemic to enhance workflows.

Using Digital Twins to Model Process Chromatography

September 01, 2021

Manufacturing

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Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

Opportunities for Digital Twins

September 01, 2021

Manufacturing

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Models of biopharmaceutical processes can be used for speeding development and improving process control.

How Pure is Pure? Understanding Reagent Purity Grades

September 01, 2021

Quality/Regulations

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As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.

The Impact of Insufficient Oversight

September 01, 2021

Quality/Regulations

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BioPharm International asked Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, about how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

In Vitro Pulls Ahead of In Vivo for Adventitious Agent Testing

September 01, 2021

Analytics

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Scientific advances open the way to alternatives to animal testing and in-vivo assays.

Trends Affecting Biopharmaceutical Manufacturing

September 01, 2021

Special Coverage

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Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.

Biosimilars Move to Center Stage

September 01, 2021

Regulatory Beat

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Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

Improve Automation, but Beware of the Pitfalls

September 01, 2021

Ask The Expert

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Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.

The Next Chapter

September 01, 2021

From the Editor

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The mission continues. Let science be the guide.