South Florida drugmaker opens sterile drug facility

BPI Labs has opened a $17 million, 20,000-square-foot sterile manufacturing facility in Largo, Florida, with 30 employees. (BPI Labs)

A South Florida company working on generic sterile injectable drugs is moving toward a fully automated manufacturing facility to be ready when its candidates are.

BPI Labs has so far invested $17 million in a 20,000-square-foot facility in Largo, Florida, where it has 30 workers, a spokeswoman said in an email. .

The facility has robotic aseptic filling work cells with gloveless isolators as well as research and development, quality control and assurance laboratories and a warehouse. BPI’s goal, she said, is to move to advanced manufacturing technologies and to use single-use dedicated systems to manufacture its sterile injections.

RELATED: Thermo Fisher expands biologics manufacturing at 3 sites

BPI Labs, a wholly owned subsidiary of generics maker Belcher Pharmaceuticals, says it is working on specialized small-molecule drugs including a generic of a branded medication that has little or no competition. According to an FDA letter (PDF), BPI received tentative approval for its generic of Sanofi’s prostate cancer injection Jevtana once the patent lapses in 2021.

The new BPI facility comes online as drugmakers and CDMOs both are building up their sterile drug capacities. Illinois-based Sagent Pharmaceuticals recently acquired an FDA-approved small molecule and biologics manufacturing site in Raleigh, North Carolina, to provide its Japanese parent, generics maker Nichi-Iko, with a U.S. facility.

And Thermo Fisher Scientific is investing $150 million in additional capacity for sterile liquid and lyophilized product development and commercial manufacturing at sites in Greenville, North Carolina, as well as Monza and Ferentino, Italy. Each site will get aseptic filling lines and isolator technology.