Mfg News: BioNTech, ImmunityBio & MoreBy
A roundup of manufacturing news from BioNTech, ImmunityBio, and Mark Cuban Cost Plus Drug Company.
BioNTech Plans Modular mRNA Vaccine Mfg in Africa
BioNTech, a Mainz, Germany bio/pharmaceutical company partnered with Pfizer for the companies COVID-19 vaccine, plans to launch scalable vaccine production in Africa by developing and delivering modular mRNA manufacturing facilities using containers.
The manufacturing units consists of one drug substance and one formulation module, each called a BioNTainer. Each module is built of six ISO sized containers (2.6 m x 2.4 m x 12 m). Together, the two modules require 800 square meters of space. This design allows for mRNA vaccine production in bulk (mRNA manufacturing and formulation) while fill–finish will be taken over by local partners. The manufacturing platform can be used to manufacture mRNA vaccines, such as Pfizer’s/BioNTech’s COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved, or authorized by regulatory authorities.
The establishment of the first mRNA manufacturing facility by BioNTech in the African Union is expected to start in mid-2022. The first BioNTainer is expected to arrive in Africa in the second half of 2022. Manufacturing in the first BioNTainer is planned to begin approximately 12 months after the delivery of the modules to its final location in Africa. BioNTech expects to ship BioNTainers to Rwanda, Senegal, and potentially South Africa in close coordination with the respective countries and the African Union.
ImmunityBio Acquires Biomanufacturing Facility
ImmunityBio, a Culver City, California-based, clinical-stage immunotherapy company, has completed its acquisition of the leasehold interest in a biomanufacturing facility from Athenex, a Buffalo, New York-based bio/pharmaceutical company.
The new 409,000-square-foot production facility, located in Dunkirk, New York, includes cleanrooms for upstream and downstream manufacturing activities, as well as fill–finish and large-scale lyophilization capabilities.
Mark Cuban’s Cost Plus Drug Company Launches New Mfg Facility
Mark Cuban Cost Plus Drug Company (MCCPDC), an online pharmacy founded by Mark Cuban, a US-based billionaire entrepreneur, has launched a pharmaceutical production facility in Dallas, Texas.
The 22,000-square-foot fill–finish facility will support the formulation, filling, and packaging of sterile medicines, with later plans to expand into private-label injectables.
Last month (January 2021), MCCPDC launched its online pharmacy, including an inventory of 100 generic drugs, and established a pharmacy benefit manager operation. The company is designed to provide generic drugs at lower costs.