CDMO Particle Sciences making leap from clinical to commercial production

Particle Sciences expects to have commercial manufacturing capabilities up and running at its Bethlehem, Pennsylvania, facility by the end of the year and intends to manufacture both sterile and nonsterile products there.

The project is part of $60 million in projects that the company’s parent, Cleveland, Ohio-based Lubrizol, recently announced. Lubrizol is putting the remaining $50 million into expanded manufacturing of excipients, polymers and its medical device work. Lubrizol acquired Particle Sciences in 2015. Until now, the CDMO has done only clinical supply production.

The commercial production facility is being built adjacent to the existing Particle Sciences development and clinical trial manufacturing site, the company said. It will handle highly potent compounds, organic solvent processing, nonsterile and sterile products, Lubrizol said. It is slated to be complete in the fourth quarter.

Particle Sciences CEO Mark Mitchnick, who founded the company in 1991, told The Morning Call that Lubrizol is investing $10 million in the expansion, which will lead to Particle Sciences adding 30 jobs at the site. It currently has 85 there.

The buildup comes even as bigger players have been snatching up smaller CDMOs, particularly those with sterile capabilities. The Lubrizol announcement came at the same time that Albany, New York-based Albany Molecular Research Inc. (AMRI) last week announced it would be acquired by equity investors The Carlyle Group and GTCR in a deal worth more than $920 million.