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LabMSR™ – MICROSPHERE REFINER

FOR MICROSPHERE DEPOT FORMULATION

PREDICTIVE MICROSPHERE SCALE-UP: DELIVERED

The MSR™ range is globally recognised as the industry’s most performant microsphere filtration and drying solution.

overview
features
services
get in touch

PREDICTIVE MICROSPHERE SCALE-UP: DELIVERED

The MSR™ range is globally recognised as the industry’s most performant microsphere filtration and drying solution.

overview
features
services
get in touch

AT A GLANCE

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.

MORE ABOUT MICROSPHERES

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™).

AT A GLANCE

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.

MORE ABOUT MICROSPHERES

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™).

INDUSTRY APPLICATIONS

INDUSTRIES PRODUCTION SCALE PROCESSES PRODUCT FORM INGREDIENTS
Pharmaceuticals GLP batches De-watering Suspension API drugs
Chemicals Pre-clinical Single pass filtration Slurry Polymers
Special processes Pilot development Loop filtration Wet cake Drug depot
Material sciences Process optimisation Re-slurry Powder Intermediates
Scale-up/Scale-down Washing Semi-solids Raw Materials
Drying & Freeze-drying Excipients
Discharge Reagents

INDUSTRY APPLICATIONS

INDUSTRIES PRODUCTION SCALE PROCESSES PRODUCT FORM INGREDIENTS
Pharmaceuticals GLP batches De-watering Suspension API drugs
Chemicals Pre-clinical Single pass filtration Slurry Polymers
Special processes Pilot development Loop filtration Wet cake Drug depot
Material sciences Process optimisation Re-slurry Powder Intermediates
Scale-up/Scale-down Washing Semi-solids Raw Materials
Drying & Freeze-drying Excipients
Discharge Reagents

VESSEL SIZES

0.001 Model
Typical Product Cake Volume (process-dependant) 2.5 – 0.40L
Maximum Liquid Volume 2.10L
Equipment Dimensions (L x W x H) 1,340 x 1,030 x 1,750mm

VESSEL SIZES

0.001 Model
Typical Product Cake Volume (process-dependant) 2.5 – 0.40L
Maximum Liquid Volume 2.10L
Equipment Dimensions (L x W x H) 1,340 x 1,030 x 1,750mm

UPGRADE OPTIONS

Standard LabMSR™ Upgrade Options
De-watering Method Suitable for Single Pass and Loop De-watering
Filtration Step(s) Single Filtration (Refiner) Dual Filtration (Scalper + Refiner)
Drying Method Suitable for Vacuum Drying and Freeze-Drying

UPGRADE OPTIONS

Standard LabMSR™ Upgrade Options
De-watering Method Suitable for Single Pass and Loop De-watering
Filtration Step(s) Single Filtration (Refiner) Dual Filtration (Scalper + Refiner)
Drying Method Suitable for Vacuum Drying and Freeze-Drying

FEATURES & BENEFITS

The purpose of the LabMSR™ is to provide R&D staff with an innovative tool enabling them to complete reliable product scale-up activities and refine their process parameters while being in a laboratory environment. The LabMSR™ will allow its end-users to reproduce the following processes, in particular:
  • Microsphere Classification/Filtration/De-watering
  • Microspheres Washing
  • Microspheres Drying, including Freeze-Drying
  • Microspheres Discharge/Recovery
Whilst the LabMSR™ vessel can be steamed-in-place, its design was uniquely developed for laboratory activities and is not recommended for commercial batch production.

Developing complex drug formulations such as microsphere delivery systems has traditionally been challenging for most drug manufacturers, big or small. Ensuring that the chosen process technology used at R&D or pilot stage can be fully scalable to larger production batches is crucial. Finding out too late that a microsphere process is not scalable can have devastating impact and cost millions of dollars to drug manufacturers.

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.

Microspheres being extremely valuable medicines to develop and produce, every drug manufacturer has the imperative to maximize their product recovery in order to secure their competitive position in the global market. The core features of our LabMSR™ system were designed keeping this crucial requirement in mind.

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.

The LabMSR™ is suitable for multi-product applications and is the ideal tool to develop a wide range of microsphere drugs. It was designed to allow manufacturers to develop their drug pipeline by remaining agile and adaptable to ever-changing production requirements.

FILTRATION AGILITY DRYING AGILITY CLEANING AGILITY
Multi-zone filtration Multi-zone drying CIP spray-ball
Loop or single-pass filtration Agitated vacuum drying (positive temp.) Fully drainable design
Quick filtration media change-over Freeze-drying No product traps

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.

LabMSR™ SERVICES

At PSL, we provide our industry partners with more than just process hardware. We take your process further together by offering a wide range of services to optimise the installation, operation and maintenance of your PSL LabMSR™.

By opting for our unique COPE and SERVE services, you can rest assured that you will receive and maintain a high-performing LabMSR™ production system, fine-tuned to your unique process requirements.

The Centre of Process Excellence is the process development arm of PSL. It was created in 2015 to offer the industry a collaborative space in which manufacturers and process developers can explore new ideas and learn about innovative production techniques.

EXPLORE COPE

PSL Serve is our dedicated customer care, on-site service and spares team. They are technical specialists, here to aid the smooth installation of new equipment, along with the servicing and repairs of existing PSL equipment and any spare parts required.

EXPLORE PSL SERVE

RESOURCES

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    HOW CAN PSL HELP WITH YOUR NEXT PROJECT?

    Contact us to see how PSL can assist on your next project or if you simply have a question for us. A PSL representative will respond within one working day.


      I would like to receive updates from PSL via email