12.08.22 -- Don't Miss 6 Key Topics That Changed Biopharma Testing In 2022

The ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin was recently published for public comment. In addition to therapeutic proteins and plasma products, genetically engineered viral vectors and viral vector-derived products are in scope. Explore specific guidance on these products.

In response to the increasing biologics manufacturing industry shift into single-use closed system processing technologies, as well as increasing regulatory requirements to de-risk processes, one of our facilities is moving routine expansion of suspension cells into a closed process format. Learn about our transition and its comparison to traditional processing.

Careful study of the effects of environmental conditions on your mAb is essential. Learn about key considerations regarding when and how to effectively plan your stability testing program, how to ensure the right selection of assays, and how forced degradation/accelerated studies may fit into your overall plan.

A critical aspect of developing biotechnological medicinal products is biosafety evaluation of raw materials used in their manufacture. Ovine and caprine viruses pose a risk of contamination of research cell banks when using antibodies of ovine or caprine origin for clone selection. Learn about the in vitro adventitious virus test.