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December 02, 2020
A holistic approach to validation and quality assurance is essential.
November 01, 2020
The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.
October 16, 2020
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
September 01, 2020
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
August 02, 2020
Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.
July 01, 2020
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
May 01, 2020
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.
Synthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.
February 01, 2020
The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.
January 01, 2020
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.