Downstream Processing

Eliminating Residual Impurities Starts with a Strategic Plan

July 01, 2020

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Challenges, Tools, and Strategies for Data Integrity Protection

June 01, 2020

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

Sartorius Completes Acquisition of Select Danaher Brands

May 01, 2020

Sartorius adds chromatography systems and resins, tangential flow filtration, and biomolecular characterization technologies.

What’s New in Downstream Technologies

April 01, 2020

The latest advances in downstream technologies include a fluid chromatography system, sensing and control units for hygienic valves, a compact valve platform, a membrane purification column, and a protein A affinity chromatography resin.

Building Data Quality in Generates Quality Data Out

March 02, 2020

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Challenges in Vector Purification for Gene Therapy

February 01, 2020

Developers need to transcend the limits of existing separation technologies, to maximize vector recovery while preserving therapeutic potency.

Faster, Better Bioprocessing in 2020

January 01, 2020

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

Mapping a Route for Cell and Gene Therapy Process Development

January 01, 2020

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

Lyophilization Presents Complex Challenges

January 01, 2020

Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.

Prevent, Detect, and Remove: Viral Control for Viral Vectors

December 01, 2019

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.