GSK opens $139m Benlysta expansion in Maryland

GlaxoSmithKline has increased drug substance capacity for Benlysta (belimumab) at its Rockville site. It is GSK’s second multi-million-dollar manufacturing project to open within a week

In 2017, UK-headquartered Big Biopharma firm announced plans to invest $139 million (€126 million) at its site in Rockville, Maryland to increase the active pharmaceutical ingredient (API) manufacturing capacity for its lupus drug Benlysta.

The project has now been completed, upping the Benlysta drug substance capacity at the facility by around 50%.

According to Maryland biotech news feed, the site has 2 x 20,000 L tanks in a large scale manufacturing facility on site, and 2 x 1,600 L bioreactors in a Small Scale Manufacturing (SSM) plant onsite. “This new expansion will bring a 2 x 10,000 L value stream online in the SSM building, which will increase our production capability by almost 50% to make and supply key medicines like Benlysta to patients,” Craig Malzahn, VP & site director at the Rockville site told the publication earlier this year.

The monoclonal antibody Benlysta was developed by US biotechnology firm Human Genome Sciences. GSK acquired Human Genome Sciences in 2012​ for $3.6bn, a year after Benlysta was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In 2018, Benlysta pulled in £473 million ($583 million) in sales for GSK, up 26% on the previous year.

US expansions

“At GSK, we are committed to delivering innovative medicines to patients, and that’s why we invested $139 million to expand our Rockville biopharma facility,” a GSK spokesperson told this publication.

“In fact, the investment in Rockville is one of three US manufacturing investments we’ve made since 2017 – nearly $400 million total invested in our capabilities across our vaccines and specialty portfolio.”

The news comes days after GSK opened a single-use drug substance plant in Upper Merion, Pennsylvania. The $120 million plant is set to begin practice runs for GSK’s inducible T cell co-stimulatory (ICOS) receptor-agonist candidate, GSK3359609, in clinical trials both on its own and in combination with pembrolizumab.

And earlier this year, GSK announced increasing capacity at its vaccines manufacturing facility in Hamilton, Montana.