MSR™ – MicroSphere Refiner
FOR MICROSPHERE DEPOT FORMULATION
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 MicroSphere Refiner were pioneered by analysing these systemic industry challenges and by better understanding microsphere processes with end-users directly in the field.
The MSR™ production system is a cGMP piece of equipment that allows drug developers and manufacturers to complete a wide range of aseptic processes with their microspheres at various scales. It is a one-of-its-kind solution that got developed and refined over decades following a Quality-by-Design (QbD) approach, taking into account the microspheres characteristics and process behaviour.
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 MicroSphere Refiner were pioneered by analysing these systemic industry challenges and by better understanding microsphere processes with end-users directly in the field.
The MSR™ production system is a cGMP piece of equipment that allows drug developers and manufacturers to complete a wide range of aseptic processes with their microspheres at various scales. It is a one-of-its-kind solution that got developed and refined over decades following a Quality-by-Design (QbD) approach, taking into account the microspheres characteristics and process behaviour.
INDUSTRY APPLICATIONS
| INDUSTRIES | PRODUCTION SCALE | PROCESSES | PRODUCT FORM | INGREDIENTS |
|---|---|---|---|---|
| Pharmaceuticals | Pilot development | De-watering | Suspension | API drugs |
| Chemicals | Pre-clinical | Single Pass Filtration | Slurry | Polymers |
| Special processes | Clinical | Loop Filtration | Wet cake | Intermediates |
| Material sciences | GMP production | Re-slurry | Powder | Raw materials |
| Commercial Batches | Washing | Semi-solids | Excipients | |
| Sampling | Reagents | |||
| Drying & Freeze-drying | ||||
| Discharge |
INDUSTRY APPLICATIONS
| INDUSTRIES | PRODUCTION SCALE | PROCESSES | PRODUCT FORM | INGREDIENTS |
|---|---|---|---|---|
| Pharmaceuticals | Pilot development | De-watering | Suspension | API drugs |
| Chemicals | Pre-clinical | Single Pass Filtration | Slurry | Polymers |
| Special processes | Clinical | Loop Filtration | Wet cake | Intermediates |
| Material sciences | GMP production | Re-slurry | Powder | Raw materials |
| Commercial Batches | Washing | Semi-solids | Excipients | |
| Sampling | Reagents | |||
| Drying & Freeze-drying | ||||
| Discharge |
VESSEL SIZES
| 0.05 Model | 0.125 Model | |
|---|---|---|
| Typical Product Cake Volume (process-dependant) | 1.7 – 8.7L | 4.4 – 21.8L |
| Maximum Liquid Volume | 151L | 188L |
| Equipment Dimensions (L x W x H) | 2,720 x 2,850 x 2,760mm | |
VESSEL SIZES
| 0.05 Model | 0.125 Model | |
|---|---|---|
| Typical Product Cake Volume (process-dependant) | 1.7 – 8.7L | 4.4 – 21.8L |
| Maximum Liquid Volume | 151L | 188L |
| Equipment Dimensions (L x W x H) | 2,720 x 2,850 x 2,760mm | |
UPGRADE OPTIONS
| Standard MSR™ | 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 MSR™ | 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
- Microsphere Classification/Filtration/De-watering
- Microspheres Washing
- Microspheres Drying, including Freeze-Drying
- Microspheres Sampling
- Microspheres Discharge/Recovery
The MSR™ is a fully automated system designed to remove any manual product handling by operators throughout production. Hence maximising batch-after-batch reproducibility while minimising human error. Production can start at a touch of a button and pre-designed process recipes can be initiated.
The PSL automation platform allows drug manufacturers to pre-design and pre-load software process recipes incorporating the relevant process parameters suitable for their specific production requirements. Hence adding speed and flexibility to their manufacturing processes.
PSL can comply to the major international practices and regulations for software automation, including GAMP5 (Good Automated Manufacturing Practice, version 5 by ISPE) and 21 CFR Part 11 established by the US FDA for electronic records and signatures.
Microspheres being extremely valuable medicines to develop and produce, every drug manufacturer has the imperative to maximise their product recovery in order to secure their competitive position in the global market. The core features of our MSR™ system were designed keeping this crucial requirement in mind.
The product recovery method of our MicroSphere Refiner is unique as it is fully automated and it does not require any manual product off-loading by operator through an aseptic isolator for example. Being an all-in-one solution, the MSR™ method also minimises the number of transfers and connections hence naturally maximising product yield.
| FILTRATION AGILITY | DRYING AGILITY | CLEANING AGILITY |
|---|---|---|
| One modular vessel design | Positive temperature drying | GMP design / no product traps |
| Quick filtration media change-over | Freeze-drying | CIP spray-ring option |
| Multi-zone filtration | Multi-zone drying | Suitable for potent product processing |
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 MSR™ 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.
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 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 MSR™ product range was designed to simplify the scale-up development of microsphere drugs, from early R&D activities to GLP batches and then from clinical trials to commercial production. Our solutions can ensure that 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.
MSR™ 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 MSR™.
By opting for our unique COPE and SERVE services, you can rest assured that you will receive and maintain a high-performing MSR™ production system, fine-tuned to your unique process requirements.
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