Your source for answers to the complex challenges of cell and gene therapy development. We recently spoke with Daniel Sikkema, executive director of global immunochemistry at Labcorp drug development, regarding bioanalytical support for cell and gene therapy modalities. He shared some of the current challenges in cell and gene therapy, …
Cell and gene therapy answers: Assessing the critical quality attributes, challenges and importance of CMC
Your source for answers to the complex challenges of cell and gene therapy development. Labcorp shares an introduction to CMC, key analytical methods used in assessing the Critical Quality Attributes, challenges in developing these assays and thoughts on the road ahead over the next 5-10 years. What is CMC and …
Potency Assays 101: How to Develop a CMC Relative Potency Assay eBook
The Relative Potency Assay for a typical biologic is usually the most complex assay in the release and stability specification. Relative Potency methods should be designed to be as simple as possible but should still reflect the mechanism of action (MOA) that is linked to the relevant biological properties of …