PSL is a trusted microsphere formulation specialist. Our MicroSphere Refiner (MSR™) technology has been used globally and is proven at all levels of microsphere production, from early R&D activities up to clinical trials and commercial manufacturing.
What is a Microsphere Used for?
Microspheres or micro-particles are complex drug formulations combining an Active Pharmaceutical Ingredient (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.
The MicroSphere Refiner (MSR™) is the flagship process technology of Powder Systems Ltd (PSL). It is disrupting the way microsphere drugs are traditionally developed and manufactured around the world, directly influencing drug delivery systems (DDS).
Innovative Drug Delivery
Despite their outstanding benefits for millions of patients around the world, microspheres are notoriously known to be difficult to process and develop for drug manufacturers.
Our unique MicroSphere Refiner (MSR™) technology was created to provide drug manufacturers with a reliable and innovative tool enabling them to overcome well-known issues in their microsphere scale-up development, such as filtration and drying inefficiencies, poor batch reproducibility and lack of sterility assurance.
Microsphere Production Expertise
The MSR™ technology has been globally used and proven at all levels of microsphere production, from early R&D activities up to clinical trials and commercial manufacturing. It has been utilised to successfully process well-known PLGA microsphere drugs incorporating various APIs such as Risperidone, Exenatide, Octreotide, Leuprolide, Naltrexone, etc.
Our industry references include global players from the Big Pharma as well as smaller drug innovators and generic drug manufacturers.
Worldwide Industry Recognition
The unique features and benefits of the MSR™ approach have been recognised industry-wide enabling PSL to win global awards including the prestigious Innovation Award from ACHEMA 2015, the world forum and leading show for the process industries. Our technology also won the Queen’s Award for Innovation presented by Her Majesty The Queen in the UK.
A Legacy of Innovation
The MSR™ is a one-of-its-kind solution that has been developed over the last 25 years in collaboration with industry partners through a Quality-by-Design (QbD) approach, taking into account the microspheres characteristics and process behaviour.
PSL adopted a systematic approach to the development of the MSR™ technology by pre-defining industry-wide objectives for quality production of microspheres. A particular emphasis was put on process understanding and control through P.A.T. (Process Analytical Technology).
Powered by PSL, Enhanced by C.O.P.E.™
At PSL, we provide you with more than just process hardware. We are entirely committed to bring your process further, together.
We also recognise that pharmaceutical manufacturing must become more efficient and agile so that it can better react to new market demands and trends. The C.O.P.E.™ concept was born to fulfil this vision.
The Centre of Process Excellence (C.O.P.E.™) is the process development arm of PSL. It was created to offer the industry a collaborative space in which manufacturers can explore new ideas and learn about innovative production techniques. Our C.O.P.E.™ process engineers are experienced with various microsphere processes and can help you achieve your specific production goals.
Testimonials
It has been a pleasure working with the PSL team. Their focus on design, fabrication, and customer support of our new equipment has been essential for the success of our project. I look forward to working with them again in the future.
Our company contacted PSL as we were looking for a reliable industry partner to develop our microsphere drug process. We opted for their GFD®Lab technology to complete our R&D scale-up activities and were pleased with the process outcome. We experienced consistent product quality and excellent batch reproducibility despite significantly scaling-up our production in our Lab. We also attended a Microsphere Summit organised by PSL in South Korea and appreciated the process consulting received from COPE™. We look forward to partnering again with PSL and utilising their COPE™ expertise to reach our future clinical and commercial production milestones.
It was a great pleasure to work with PSL and COPE. With their highly experienced engineering service, they served us greatly and willing to help us finding exact solution for our process needs. We would love to work again with PSL undoubtly.
