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March 16, 2024
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
October 04, 2023
EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.
May 01, 2023
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
March 15, 2023
Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.
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.