Particle Sciences to add specialised commercial manufacturing capacity
Construction has begun at the firm's facility in Bethlehem, PA in the US in preparation for starting operation next year
US drug development services provider Particle Sciences is adding commercial drug product manufacturing capacity at its facility in Bethlehem, PA.
The 18,000ft2 (approximately 1,670m2) area will include sterile and non-sterile space with lyophilisation and filling operations. Among other operations, the facility will be tailored for nano-milling and other complex processes.
Building work has already begun and the facility is expected to be operational early next year.
Particle Sciences, which became part of Lubrizol Life Sciences in September 2015, specialises in complex formulations, including particulates and drug eluting devices.
'While the general contract manufacturing organisation (CMO) industry has gone through considerable consolidation around standard dosage forms, LifeSciences has focused on complex processes such as nano-milling, high pressure homogenisation, extrusion and micro-particle fabrication. We are clearly the leader in these areas with significant technology and infrastructure advantages,' said Mark Mitchnick, LifeSciences’ Chief Medical Officer and Particle Sciences’ CEO.
'This current multi-million-dollar expansion further demonstrates our commitment and fills a gap in the global CMO space.'
Particle Sciences focuses on BCS II/III/IV molecules, biologics and highly potent compounds through a variety of technologies including emulsions, gels, micro and nano-particulates, drug/device combination products, solid solutions and others.