08.16.24 -- The Learned Intermediary Doctrine Sees Curious Change In California

Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

See how Bayesian decision rules in clinical trials can align with regulatory standards, offering intuitive and adaptive solutions amidst traditional challenges in frequentist frameworks.

Containment is growing in importance due to increasingly stringent legal requirements for packaging solid medicines. Learn in detail about containment solutions for the pharmaceutical industry.

Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help minimize delays and lead to more positive outcomes.

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

Understand the challenges and limitations of the blue dye test, and see how the sensitivity of the blue dye test compares to other methods based on a comprehensive study.

Bilayer tablets offer a number of benefits for patient care; understanding the challenges that accompany their formulation is key to enabling their successful commercialization.

Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.

Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing CGTs.