Particle Sciences to Expand Sterile Manufacturing for Complex Products and Particulates

Particle Sciences, Inc. (PSI) is expanding its sterile and aseptic manufacturing capacity generally and specifically for nano-milled drug products.

According to Mark Mitchnick, CEO at Particle Sciences: "In 2014 we initiated a record number of projects that are headed into the clinic with over 50% of those being sterile and 50% of those requiring aseptic processing. Several years ago, most of clinic bound work was developed at PSI but we have seen a significant uptick in projects that were developed at our clients’ facilities and are now being transferred to us for manufacturing. This is especially true with some of our larger multinational clients."

Particle Sciences’ cGMP facilities include dedicated high potency suites, ISO 5 areas, six ISO 7/8 suites, attached warehouse, lyophilization, and full stability and analytic support. Mitchnick added: "We are incorporating a great deal of flexibility into this latest expansion by making intelligent use of both fixed and mobile isolator assets and coupling that with our existing ICH compliant stability programs and GMP analytic services group. Of course, our formulation expertise remains at the core of our activities. Being uniquely capable of bringing complex projects from concept through to manufacturing meets a real need and offers a compelling value proposition to our clients. Last year we grew by 16% and expect positive things in 2015 as well."