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GSK Expands Biopharmaceutical Manufacturing At Rockville, Maryland, Campus

05/02/2017
GSK will invest $139 million to expand its biopharmaceutical manufacturing site in Rockville, Maryland. The project will support the growing demand for BENLYSTA (belimumab) for adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

The Rockville biopharmaceutical manufacturing site consists of two FDA-licensed facilities for large and small scale manufacturing, which employ more than 400 highly-skilled scientists, engineers and manufacturing and quality professionals among other specialists.

The facility is also expected to house production of a new subcutaneous form of belimumab which is currently under review with the FDA. GSK announced regulatory filings for a subcutaneous (self-injectable) formulation of belimumab, currently available as an intravenous formulation, in Europe and the US in 2016 and is expecting to hear from regulatory bodies in the second half of 2017. The subcutaneous formulation of belimumab is currently not approved for use anywhere in the world.

The $139 million investment will be used to provide additional internal capacity to increase bulk drug substance production by close to 50% at the Rockville site, to respond to increased demand, company officials said.

"Benlysta is the first medicine specifically developed and approved for SLE in over 50 years. We are so pleased that on the first day of Lupus Awareness Month we are able to announce this expansion in Rockville, increasing our ability to provide this important medicine to patients," said Sheri Mullen, Vice President, Immunology & Rare Diseases, GSK.

In earlier expansions, the company invested $50 million to continue to develop its Global Vaccines R&D Headquarters in Rockville, which opened in December 2016. Another $245 million was invested to transform its Upper Providence, Pennsylvania site into one of two major R&D hubs for GSK globally, which was announced in December 2014.

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