Baxalta receives CHMP positive opinion for Sanquin to begin production, enhancing global supply of plasma-based therapies

Sanquin is now licensed to produce bulk material for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) for the European Union, Iceland and Norway.

Baxalta continues to optimize its manufacturing network to support increasing global demand for plasma–based therapies. The positive opinion from CHMP allows Sanquin to process plasma supplied by Baxalta into bulk material for HYQVIA and GAMMAGARD LIQUID 10% in the European markets. These additional manufacturing capabilities also allow Baxalta to optimize capacity at other facilities to serve other regions. Baxalta will continue to supply the US market from its FDA approved manufacturing sites in the US, Austria and Italy.

“Meeting the increasing demand for plasma-based therapies is a key component of our global manufacturing strategy,” said John Furey, senior vice president and head of Global Operations, Baxalta. “This CHMP positive opinion enables Baxalta to provide additional supply of critical plasma-based therapies by leveraging our manufacturing network and regional partners to optimize our flexibility and capacity.”

Previously, as Baxter International Inc.’s BioScience business, Baxalta entered into a manufacturing services agreement with Sanquin in July 2012. The agreement enables Baxalta to gradually ramp up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-based treatments.