FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
|Articles|March 29, 2021
EMA Approves BioNTech’s COVID-19 Vaccine Manufacturing Site
Author(s)BioPharm International Editors
EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.
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BioNTech announced on March 26, 2021 that the European Medicines Agency (EMA) has approved the manufacturing of drug product for its COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.
According to a company press release, EMA has approved the production of the vaccine’s messenger RNA (mRNA) at the Marburg facility, meaning the first batches of the vaccine can be delivered to the company’s partner sites for sterile fill/finish, then distributed to the European Union and other countries. The initial batches manufactured at the Marburg site are set to be delivered during the second half of April 2021.
“A key factor in the expansion of our manufacturing network has been the set-up of this new manufacturing site in Marburg, Germany,” BioNTech said in the press release. “BioNTech plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021.”
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