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.
An All-In-One Solution
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:
Microspheres Classification/Filtration/De-watering)
Microsphere Washing
Microspheres Drying, including Freeze-Drying
Microsphere Discharge/Recovery
Putting Your Scale-Up On Auto-Pilot
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.
Microspheres are extremely valuable medicines to develop and produce.