Distress grows as manufacturers wait for suppliers to boost production. One idea: stretch inventories by qualifying single-use bioreactors for reuse.
The supply of plastic bioreactor systems used in manufacturing a wide range of vaccines, monoclonal antibodies and cell and gene therapies has tightened so much during the COVID-19 pandemic that some manufacturers are considering desperate measures to maintain production.
Normally, manufacturers go through enough of these systems, which are designed to be used once and discarded, to produce 5...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
