Newsletter | March 18, 2025

03.18.25 -- EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety

FEATURED EDITORIAL

EMA On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety

There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation.

INDUSTRY INSIGHTS

Resource Roadmap To Screening Success

Explore how tools streamline the development of cell-based therapies by optimizing processes, reducing costs, and accelerating manufacturing scalability. 

Trends In Next-Generation Delivery Technologies

Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

Particle Size Control Through Micronization: Challenges And Solutions

What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.

Engineering Approaches To Respiratory Drug Delivery

Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.

Key Considerations For Nonclinical AAV Gene Therapy Development

Looking to learn more on nonclinical AAV gene therapy development? Check out this essential eBook that will provide the latest insights on AAV gene therapy.

Continuous Manufacturing: An Evolving Technology For Drug Manufacturing

Explore the exciting developments in continuous manufacturing and learn how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.

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