The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...

It's an exciting time to be in cell therapy manufacturing and commercialization, particularly in the oncology space. This year alone, we've seen the US approval of three cell therapy products: Iovance ...

Elegen and Nutcracker Therapeutics launched a pilot program to demonstrate what they label the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer ...

Controlling the entire cell therapy production process—from material receipt to product release—is “essential,” according to AstraZeneca, which says its new $300 million manufacturing facility will be ...

While many articles have been written about cell testing in R&D labs or cell testing during manufacturing in the factory, let’s turn to the topic of cell testing for incoming inspection. This article ...

Cause-Specific Mortality in a Cohort of 1,435 Patients With Hodgkin Lymphoma Treated Between 1985 and 2014: A Nationwide Chilean Cohort Study Healthy volunteers were recruited and underwent ...