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July 02, 2022
The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
January 02, 2022
Modeling techniques can improve process control and monitoring in biopharmaceutical production.
June 01, 2021
The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
April 01, 2021
The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.
March 02, 2021
The need for real-time monitoring and control has spurred the development of new analytical tools.
December 03, 2020
The collaboration addresses the need for risk mitigation plans in cell therapies.
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.