The South Korean biotechnology company, Samsung Biologics and commercial stage biopharmaceutical company, TG Therapeutics said that it has expanded a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab.
The company Samsung Biologics said it is currently building its fourth and largest biomanufacturing facility in Incheon, Korea.
The biopharmaceutical company, 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.
After completion of the plant in 2023, Samsung Biologics will hold 620,000 liters of bio- manufacturing capacity, or about a quarter of the entire bio-CMO capacity globally.
The CEO of Samsung Biologics, John Rim, said:
“We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,”
“By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world and getting a step closer to our vision of bringing about a better life for humanity.”
The Executive Chairman and CEO of TG Therapeutics, Michael S. Weiss, said:
“Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialisation of ublituximab across both oncology and autoimmune indications.
“With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our long-standing relationship with Samsung.”
ABOUT UBLITUXIMAB
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells.
When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell.
