TG Therapeutics, Inc. [NASDAQ: TGTX] disclosed that it has inked a deal with Samsung Biologics. The large-scale manufacturing contract is related to the supply of an investigational anti-CD20 monoclonal antibody, ublituximab of TG Therapeutics. The firm has also disclosed that it has submitted a rolling submission of a BLA to the U.S. FDA demanding authorization of ublituximab, in conjunction with UKONIQ.
Furthermore, the two successful Phase 3 studies involving Ublituximab in sufferers with relapsing forms of multiple sclerosis (RMS) and a BLA is presently being ready for this indication. Presently, Samsung Biologics is constructing its fourth and largest biomanufacturing facility in Incheon, Korea. The decision to build the large facility based on the firm’s aim to serve its current and future clients all around the globe.
In addition to this, the firm will own 620,000 liters of biomanufacturing capacity, or nearly a quarter of the entire bio-CMO capacity all around the globe after the execution of the newly manufactured plant in 2023. The firm offers contract manufacturing, contract development, and testing services all from a specific location, offering end-to-end services for its customers.
Samsung has gained recognition as the global leader in biologics manufacturing, and the firm is delighted to join hands with TG Therapeutics. The firm is planning to explore the potential marketing of ublituximab across both oncology and autoimmune indications.