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news.Baxter International has announced the formal opening of its first advanced recombinant biologic facility in Singapore, and expansion plans for a new recombinant protein processing suite.
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The current suite supports the processing of ADVATE [Antihemophilic Factor (Recombinant)], the market leading full-length recombinant factor VIII (rFVIII) worldwide for the treatment of patients with hemophilia A.
The second suite will initially process RIXUBIS [Coagulation Factor IX (Recombinant)], a recombinant factor IX (rFIX) protein for the treatment of adults with hemophilia B and, when operational, will be the primary global commercial processing facility. It will also support production of the company’s investigational extended half-life recombinant FVIII treatment BAX 855 upon regulatory approval.
Today’s announcement strengthens Baxter’s leadership in hemophilia and underscores its commitment to increasing access to therapy and improving standards of care for hemophilia patients globally. In total, the establishment of the facility and new investment will have created 450 biopharmaceutical jobs by 2015 in Singapore.
”As a long-standing, established leader in the global hemophilia community, Baxter has focused efforts on improving standards of care for people with hemophilia,” said Ludwig Hantson, Ph.D., president of Baxter BioScience.
”The opening of the Singapore facility reinforces our continued commitment to expanding access to advanced, high quality treatments for patients around the world.”
”Baxter’s expansion of its biologics footprint in Singapore reinforces our position as a leading biologics hub. This facility will support Baxter’s growth in the global market and Singapore celebrates its opening. EDB will continue to invest in talent development, supporting infrastructure and new technologies to support the biologics sector,” said Mr. Yeoh Keat Chuan, Managing Director at the Singapore Economic Development Board (EDB), who officiated the opening ceremony.
The Singapore facility received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE. This allows the facility to process and supply ADVATE to the European Union, Iceland and Norway.
The biologics facility in Singapore currently employs more than 400 production staff and expects to reach 450 by 2015 to support the second processing suite. The facility is the third location in the world supporting ADVATE processing, making this the only recombinant factor VIII treatment processed at three separate sites and providing unprecedented security of a triple-source capability.
Speaking at the opening of the facility, Jean-Luc Butel, corporate vice president and president of Baxter’s international operations said, ”Singapore’s biotech industry has seen tremendous growth in recent years and Baxter is proud to have been a part of this journey. Baxter is grateful to the Singapore Economic Development Board for their support in establishing this facility and for its commitment to collaborations that advance access to quality healthcare. As we have invested in training our employees to support this state-of-the-art technology, we remain committed to partnering with the Singapore Economic Development Board and other government agency partners to elevate the quality of the healthcare workforce in Singapore.”
About ADVATE [Antihemophilic Factor (Recombinant)]
ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for:
– Control and prevention of bleeding episodes.
– Perioperative management.
– Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy and safety profile. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE was approved by the Health Sciences Authority (HSA) in Singapore in July 2008 and is approved in 62 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Israel, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Russia, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay and Venezuela.
ADVATE is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.