Mark Mitchnick, MD
Lubrizol’s Particle Sciences
Mark Mitchnick, MD, Chief Executive Officer, Particle Sciences, a Lubrizol company, outlined the company’s recent investment in commercial manufacturing, the latest in a series of growth initiatives by the company. Particle Sciences, which was acquired by Lubrizol in 2015 and is part of Lubrizol Life Sciences, is a contract development and manufacturing organization specializing in development and manufacturing services for complex drug products. Specialized capabilities include micro/nano particulates, polymeric devices, aseptic processing, and high pressure homogenization.
Particle Sciences is investing in a new facility in Bethlehem, Pennsylvania that 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. The facility is scheduled to be completed in the third quarter of 2017. Dr Mitchnick noted that the first products are already scheduled, including a nanoparticulate abbreviated new drug application (ANDA) and a microparticulate ANDA.
Other projects under discussion include those involving polymeric nanoparticles/microparticles, emulsions, and nanoparticulate suspensions. Particle Sciences’ commercial manufacturing facility is separate but adjacent to its development and clinical trial manufacturing site. Designed to produce both sterile and non-sterile dosage forms, the manufacturing space is compliant with international regulatory requirements and was built with flexibility and adaptability in mind. The facility can process highly potent compounds, organic solvents, and perform aseptic/sterile filling. The automated aseptic filling equipment was designed to accommodate a variety of primary packaging configurations. Release testing and stability programs are to be conducted on site. Additional highlights of the facility include: GMP development and production of complex products, such as ophthalmic suspensions / solutions, sterile polymeric nanoparticulate formulations, parenteral products, bioabsorable micro/nanoparticulate depots, and nanoemulsions.