Quality by Design

Particle Measuring Systems Announce Acquisition of Environmental Monitoring Services Limited and EMS Particle Solutions

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.

Optimizing the Manufacture of Emerging Therapies

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.

Points to Consider for Knowledge Management Acceleration

March 15, 2023

Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.

Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?

July 02, 2022

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Recent Trends in Data Analytics for Upstream Process Workflows

January 02, 2022

Modeling techniques can improve process control and monitoring in biopharmaceutical production.

Development Strategies for Cell and Gene Therapy Methods

June 01, 2021

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

Fluid Handling Systems are Seeing Benefit from Single-Use Technologies

April 01, 2021

The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.

Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing

March 02, 2021

The need for real-time monitoring and control has spurred the development of new analytical tools.

Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management

December 03, 2020

The collaboration addresses the need for risk mitigation plans in cell therapies.

Prepping Fill/Finish Systems to Ensure Quality Output

December 02, 2020

A holistic approach to validation and quality assurance is essential.