Topic: cell manufacturing
The FDA has issued guidance on continuous manufacturing and is allocating $58 million to move forward advanced manufacturing processes.
General Electric is selling its biomanufacturing operations to conglomerate Danaher for $21.4 billion.
Novartis biotech AveXis will invest another $60 million and hire another 200 workers for the site it is building in Durham, North Carolina.
Japan’s Hitachi has acquired European cell manufacturing CDMO with two facilities in Germany.
Seeing an opportunity, Japan’s Fujifilm will build a U.S. stem cell manufacturing facility not only for its own efforts but also as a CDMO.
With about $225 million in hand from the IPO, Orchard Therapeutics is starting on a plant in California for its gene therapy candidates.
Abzena will invest $20 million in a cell manufacturing facility, and Catalent is spending $2.5 million on a clinical supply facility in China.
Astellas will invest $255 million in production and R&D as it pushes into gene and cell therapies for cancer and other diseases.
Another cell manufacturing facility will be built in the U.S., this by a transatlantic biotech in which GlaxoSmithKline owns a sizable share.
Novartis is looking ahead to China for introduction of its CAR-T treatment Kymriah with a deal for manufacturing there.