Quality/GMPs

Articles

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

Technology Innovations Improve Process Chromatography Performance

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Using Process Modeling to Troubleshoot a Bioprocess

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

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

Eliminating Residual Impurities Starts with a Strategic Plan

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

Shaping IR Spectroscopy into a Powerful Tool for Biopharma Characterizations

Synthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.

Biopharmaceutical Manufacturing and the Power of Synthetic Biology

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

The Need for Advanced Process Modeling for New Therapeutic Biologics

Agnes Shanley is senior editor of BioPharm International.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset. 

Getting to the Root of Quality Problems

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of BioPharm International's Editorial Advisory Board.

Quality risk management plans provide identified actions to ensure a continuous supply of safe
and effective drug products


Quality Risk Management Plans Create Effective Quality Systems

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.


Review by Exception: Connecting the Dots for Faster Batch Release

Gary Dailey is vice-president, Global Marketing, Electronic Materials, at Avantor.

Claudia BerrÃ³n is senior vice-president, Strategy and Commercial Operations, Biopharma Production at Avantor.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

Quality by Design