Samsung Biologics, TG Therapeutics Expand Collaboration For Manufacture Of Ublituximab

(RTTNews) - Samsung Biologics and TG Therapeutics (TGTX) said that it has expanded a large-scale contract manufacturing deal for the supply of TG Therapeutics' ublituximab, an investigational anti-CD20 monoclonal antibody.

TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQ (umbralisib), TG Therapeutics' oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with CLL, based primarily on the positive results from the UNITY-CLL Phase 3 trial.

Samsung Biologics said it is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or about a quarter of the entire bio-CMO capacity globally.

The company provides contract manufacturing, contract development, and testing services all from a single location, offering end-to-end services for its clients.