02.01.24 -- Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses

The success of CGTs hinges upon adherence to specific logistics protocols. Discover how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.

The new GMP regulations coming out of the European Union will have a big impact on pharmaceutical manufacturers. Learn about executing a CSS, cleaning, disinfection, and much more.

It is important to consider several factors in the overall development approach during the early phases in order to de-risk late-phase development.

Medical and pharmaceutical products are often packaged in fluid-filled containers. Read about container closure integrity testing using high voltage leak detection, how the technology works, and more.

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoid the pitfalls that stall many promising therapeutics.

Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow/fill/seal in the packaging of pharmaceutical liquids.

A global EPCMV firm worked closely with a cleanroom vendor to deliver a manufacturing facility that meets guidelines for BSL2–Large Scale. Learn about the facility, the companies involved, and more.

Gain insight into a recent project that applied process improvement methodology to the process validation step, ultimately providing an optimized, robust process and an economic advantage.

Explore data demonstrating the successful engineering of a single-use tangential flow filtration system designed to meet the specific requirements of ADC processes.

Lonza principal scientist, Deanna Mudie, Ph.D., covers the design of dissolution media to support biopredictive dissolution testing and how the properties of a drug and formulation affect performance.

Effective precision weighing systems enable users to balance product throughput, center distance, and standard deviation. Explore key considerations in this technology's development and weighing methods.

Read about solutions that eliminate packaging complexity and allow the blister line to operate with significantly improved utilization of the assets and operational effectiveness.