TC Biopharm approved by MHRA to apply 18-month shelf-life to OmnImmune
TC Biopharm announced that it has received approval from the U.K. regulatory body, MHRA, to apply an 18-month extrapolated shelf life to its current allogeneic cell therapy product, OmnImmune. "This award enables TC BioPharm to ship and store sufficient product which can then be held cryopreserved at clinical sites to fulfill the requirements not only for its current Advanced Myeloid Leukemia trial ACHIEVE, but also for future clinical trials and eventually commercial treatment of patients. Additionally, TC BioPharm's in-house quality control department will continue to gather data in order to extend the shelf-life of OmnImmune," the company stated.