The Lubrizol Corporation’s LifeSciences, the leading contract development and manufacturing organization (CDMO) for complex drug products, is adding commercial drug product manufacturing capacity at its Particle Sciences facility in Bethlehem, PA. The 18,000 square foot capacity will include both sterile and non-sterile space with complete lyophilization and filling operations. Among other things, the facility will be tailored for nano-milling and other complex processes.
“As part of our plans for continued growth in this market, we have accelerated the commercial expansion plans at Particle Sciences. The work has already begun, and we plan to be operational in early 2017 with some of the capacity already spoken for by clients with whom we are currently developing products,” explains Mark Mitchnick, LifeSciences’ chief medical officer and Particle Sciences’ CEO.
Particle Sciences has developed special expertise in particulates and drug eluting devices. Over the last several years it has taken multiple products into the clinic on behalf of its clients and has a busy 2016 schedule of clinical trial material production in place.
“While the general contract manufacturing organization (CMO) industry has gone through considerable consolidation around standard dosage forms, LifeSciences has focused on complex processes such as nano-milling, high pressure homogenization, extrusion and micro-particle fabrication. We are clearly the leader in these areas with significant technology and infrastructure advantages. This current multi-million-dollar expansion further demonstrates our commitment and fills a gap in the global CMO space,” Mitchnick adds.
Deb Langer, vice president and general manager of Lubrizol LifeSciences comments, “Along with expansion at several of our medical device manufacturing facilities, the addition of commercial manufacturing at Particle Sciences keeps us right on track as we grow Lubrizol LifeSciences into the premier pharmaceutical CDMO. Working closely with our clients, we leverage our deep material sciences expertise, global supply chain and operational excellence in the increasingly demanding pharmaceutical and medical device industries. We have penned multiple manufacturing and partnering agreements so far and look to enter into many more. Our corporate strength affords us a unique ability to structure such relationships.”