Samsung Biologics and TG Therapeutics expand mAb manufacturing contract

Samsung Biologics and TG therapeutics have expanded their existing contract to manufacture Ublituximab, a monoclonal antibody drug to treat multiple sclerosis. 

Korean Contract development manufacturing organization (CDMO) Samsung Biologics and US-based firm TG Therapeutics have expanded their 2018 contract to produce TG’s ublituximab (TG-1101), a monoclonal antibody (mAb) that targets an epitope on CD20-expressing B-cells.

Samsung Biologics did not divulge ublituximab’s manufacturing process due to client confidentiality. However, a spokeswoman for the firm told BioProcess Insider it will “offer large-scale manufacturing services for the potential commercialization of ublituximab and secure long-term capacity for the product.”

Image/iStock: metamorworks

According to the CDMO, the expansion of the contract will aid global manufacturing as the increase in large-scale manufacturing “will allow the products of TG Therapeutics to accommodate the increasing needs in the market and reach its patients faster,” as well as securing long-term manufacturing capacity.

TG Therapeutics has already submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) requesting clearance of ublituximab but it has not yet received approval.

Ublituximab is currently in Phase III trials with its Phase II study showing positive reports of ‘>99% B-cell depletion by week four and advantages on MRI and clinical parameters.’

Samsung Biologics did not comment on whether it needed to scale-up in staff or space to service the deal due to confidentiality but the CDMO is building its fourth and largest biomanufacturing plant in Incheon, Korea.

“With an increase in demand for manufacturing at Samsung Biologics, our plant one, two, and three are showing steady operations. Therefore, upon plant four completion in 2023, we are planning to look into this facility for our clients and leverage our up-to-date technology to meet the increasing needs,” they told us.