Biological activity is a critical quality attribute for biological products. As this class of therapeutics expands and becomes more complex, with the growth of antibody-drug conjugates and cell and gene therapies for example, there are increasing challenges in developing scientifically relevant biological potency assays suitable for each stage of the product life cycle and, in particular, assays that are sufficiently robust for use in the GMP QC environment supporting clinical and commercial manufacturing.
This meeting will consider approaches to overcoming those challenges, including strategies for transitioning assays from R&D into the QC environment, application of new technologies to improve robustness of assays and methods for measuring the potency of cell therapies.
This meeting will consider approaches to overcoming those challenges, including strategies for transitioning assays from R&D into the QC environment, application of new technologies to improve robustness of assays and methods for measuring the potency of cell therapies.
