Powder Systems Ltd (PSL) has announced its investment in a new Centre of Process Excellence (COPE) at its UK facility in response to the growing demand from global pharmaceutical manufacturers for providing additional process optimisation of their microsphere drugs.
MSR Microsphere refiner
Microspheres or micro-particles are complex drug formulations combining an API with an FDA-approved polymer such as PLGA. Microsphere drugs enable the sustained release of APIs into patients over prolonged periods of time, varying from weeks up to several months.
Despite their benefits for millions of patients around the world, microspheres are notoriously known to be difficult to process and develop for drug manufacturers.
The new COPE facility will officially open on September 2020. The facility will be opened as part of the upcoming Microsphere Summit organised by PSL in Liverpool (9–10 September). Drug manufacturers will be attending from Europe, America and Asia.
The facility will be designed to mirror the existing services currently provided by another COPE facility that opened in Philadelphia, US, in 2015. It will focus on optimising complex drug formulation processes such as filtration, drying, yield recovery and scale-up of microspheres.
“We are seeing an increase in demand from global microsphere drug players, including big pharma and generic manufacturers, for a range of additional process services to be completed prior to delivery of our technology at their production sites,” said Amanda Gowans, CEO of Powder Systems Group.
The new innovation centre will be located inside PSL’s current production facility located in Speke, Liverpool. It will be designed to enable drug manufacturers to run their specific drug process in a non-GMP manner hence offering the flexibility to troubleshoot and exploring new process concepts in a separate facility without impacting their actual production line. It will offer an intermediate step towards successful drug development and ultimate commercialisation.
PSL's range (L-R): Sterile process isolator; Lab Nutsche Filter Dryers; GFD
Gowans said: “[The facility] will also streamline [customer] drug development and reduce any potential delays due to unnecessary trouble-shooting on site. Our hands-on approach and passion for finding the best solution will help deliver projects successfully and solve the toughest problems - together.”
"With a range of technical capabilities and expertise in complex drug delivery developed over the last three decades, PSL engineers and scientists are looking forward to working side by side with our industry partners and taking on their formulation and production challenges in this new facility," Gowans added.