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PSL - LabMSR™ - Microsphere Refiner
The LabMSR system is a GLP piece of equipment that has been developed to enable global drug manufacturers to generally replicate, at R&D scale, some of the process benefits of PSL’s full scale production MicroSphere Refiners (MSR). Due to their characteristics and properties, polymeric microspheres have traditionally been known to be difficult to process for manufacturers – especially as the batch size gradually increases as part of the microsphere product development. The unique features of our LabMSR were developed following a Quality-by-Design (QbD) approach, taking into account the microspheres characteristics and process behaviour.
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Microsphere Classification/Filtration/De-watering
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Microspheres Washing
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Microspheres Drying, including Freeze-Drying
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Microspheres Discharge/Recovery
Product Recovery - A Crucial Requirement
As per our MicroSphere Refiner for GMP production, the product recovery method used by our LabMSR™ is completed by tilting the vessel. Being an all-in-one solution, the LabMSR™ method also minimizes the number of transfers and connections hence naturally maximizing product yield.
FILTRATION AGILITY
- Multi-zone filtration
- Loop or single-pass filtration
- Quick filtration media change-over
DRYING AGILITY
- Multi-zone drying
- Agitated vacuum drying (positive temp.)
- Freeze-drying
CLEANING AGILITY
- CIP spray-ba
- Fully drainable design
- No product traps
Putting Your Scale-Up On Auto-Pilot
The LabMSR™ is the ideal solution to bridge the gap between your early R&D development activities and your GMP clinical batch production. This unique technology was developed by PSL to put your scale-up development on autopilot and to ensure that your key process objectives (such as product yield, product quality and integrity, batch consistency, etc.) and key production parameters (such as filtration time, washing time, drying time, etc.) can be maintained at every scale.
The implementation of Process Analytical Technology (PAT) initiative in the pharmaceutical industry has been encouraged by the US FDA in order to ensure better product quality control and quicker time to market.
The LabMSR™ technology has embraced the PAT initiative as it allows drug manufacturers to complete real-time monitoring of their microsphere product quality and integrity during various production stages such as filtration and drying processes (including lyophilisation). The integration of PAT reduces the need for trial and error and helps drug companies towards right-first-time manufacturing, hence reducing drug development times for microspheres – traditionally more tedious than regular drugs.
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).
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 Queen Elizabeth II in the UK.
0.01 Model
- Typical Product Cake Volume (process-dependant): 0.25 – 0.40L
- Maximum Liquid Volume: 2.10L
- Equipment Dimensions (L x W x H): 1,340 x 1,030 x 1,750mm
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.
