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MICROSPHERE FORMULATION

PSL is the trusted microsphere processing specialist. Our innovative MicroSphere Refiner (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.

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Home / Solutions / Microsphere Formulation

MICROSPHERE FORMULATION

PSL is the trusted microsphere processing specialist. Our innovative MicroSphere Refiner (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.

TRANSFORMING THE WORLD OF
MICROSPHERE FORMULATION

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.

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.

TRANSFORMING THE WORLD OF
MICROSPHERE FORMULATION

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.

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.

CHALLENGING THE STATUS-QUO

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 all well-known issues in their microsphere scale-up development, such as filtration & drying inefficiencies, poor batch reproducibility and lack of sterility assurance.

CHALLENGING THE STATUS-QUO

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 all well-known issues in their microsphere scale-up development, such as filtration & drying inefficiencies, poor batch reproducibility and lack of sterility assurance.

DECADES OF EXPERIENCE IN PRODUCTION

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.

r&d scale
Pre-clinical
Commercial

DECADES OF EXPERIENCE IN PRODUCTION

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.

r&d scale
Pre-clinical
Commercial

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 COPE concept was born to fulfil this vision.

The Centre of Process Excellence (COPE) 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 COPE process engineers are experienced with various microsphere processes and can help you achieve your specific production goals.

explore cope

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 COPE concept was born to fulfil this vision.

The Centre of Process Excellence (COPE) 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 COPE process engineers are experienced with various microsphere processes and can help you achieve your specific production goals.

explore cope

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).

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).

GLOBAL 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.

GLOBAL 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.

CONNECTING THE GLOBAL INDUSTRY

Since 2014, PSL has hosted a series of international summits in Europe, USA and Asia, bringing together industry players in the field of Long Acting Release (LAR) injectable drug development and production through a forum of discussion, ideas and solutions.

Powder Systems Ltd (PSL) is also regularly showcasing our latest technology advancements at various industry events organised by organisations such as ISPE (International Society for Pharmaceutical Engineering) and CRS (Controlled Release Society).

To be notified of any future Microsphere Summits, you can register your interest by clicking here.

CONNECTING THE GLOBAL INDUSTRY

Since 2014, PSL has hosted a series of international summits in Europe, USA and Asia, bringing together industry players in the field of Long Acting Release (LAR) injectable drug development and production through a forum of discussion, ideas and solutions.

Powder Systems Ltd (PSL) is also regularly showcasing our latest technology advancements at various industry events organised by organisations such as ISPE (International Society for Pharmaceutical Engineering) and CRS (Controlled Release Society).

To be notified of any future Microsphere Summits, you can register your interest by clicking here.

INDUSTRY 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.

Ryan Shore - Director Corporate Engineering, Amylin Pharmaceuticals, USA

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.

Pharmaceutical Process Engineer, Confidential Company, Switzerland
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.
Jin Ho Lee - Senior Researcher , BCWorld Pharm, South Korea

SOLUTIONS

GFD®

Cake volume: 0.1L to 0.5L
For early R&D activities.

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LabMSR™

Cake volume: 0.25L to 0.4L
For GLP / pre-clinical activities.

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MSR™

Cake volume: 0.8L to 22L
For GMP / Clinical / Commercial activities.

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