05.02.25 -- Why Pharma Risk Assessments Should Include 'Working Together Alone'

Explore the key advantages of stick-pack formats for pharmaceuticals and nutraceuticals, from enhanced product safety and cost-efficiency to improved compliance and marketability.

Our findings highlight the potential of combining irinotecan with immune checkpoint inhibitors in MC38 tumor models, which demonstrates a promising approach for future research and therapeutic strategies.

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

The FDA recommends a new approach to computer system validation called Computer Software Assurance. Gain insights that can help you understand CSA and how to implement it.

Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

Examine a solution offering that is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Experts explain what a pyrogen is as well as the differences between an endotoxin pyrogen and a non-endotoxin pyrogen. Learn why it is immensely important to detect non-endotoxin pyrogens.

Failure to identify a compound’s red flags early in development often manifests as program delays or failures. Uncover how to avoid these setbacks through complete molecular characterization.