While cell therapy remains a very promising approach to developing much-needed new immunotherapies, significant challenges will have to be overcome in order to realize the FDA’s twenty-first century vision of making complex ATMPs widely and cost-effectively available to patients.
Very soon after publication of the FY2018 data on human tissue and cell therapy products, the FDA released the data from FY2019, which we address here. We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area.
By Dr. Maura C. Kibbey, senior scientific fellow, global biologics, USP, and Dr. Jim Richardson, senior science and standards liaison in global biologics, USP
USP held its eighth Bioassay workshop September 18 and 19 and expanded its scope to cover challenges related to potency assays for cell and gene therapy (CGT) products. Read more about the speakers and breakout sessions from the event.
Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. By proactively preparing for this meeting, sponsors can set themselves up for productive discussions that may help in identifying areas of regulatory flexibility.
Single-use connection technologies are expected to play a critical role in the commercial manufacturing of cell and gene therapies. Learn about the types of connection technologies and selection considerations.
Connect With Cell & Gene: