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...
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
