Microsphere process scale-up system for r&d
Scaling up the production of polymeric microspheres from R&D to full-scale manufacturing presents significant challenges, particularly in maintaining consistency in filtration, washing, and drying processes. These issues can result in costly bottlenecks and reduced product yield.
Enables microsphere scale-up and process refinement
The LabMSR™ system by Powder Systems Limited (PSL) is designed for GLP laboratories to facilitate the reliable scale-up of microsphere production. Incorporating unique features developed through a Quality-by-Design (QbD) approach, this system allows for consistent microsphere classification, filtration, washing, and drying, including freeze-drying. The LabMSR™ system reduces the number of transfers and connections, enhancing product yield by tilting the vessel for efficient product recovery. Capable of handling multiple products, this versatile system supports both single-pass and loop de-watering, along with agitated vacuum and freeze-drying. Its design also adheres to Process Analytical Technology (PAT) guidelines, enabling real-time quality monitoring and reducing development times. The LabMSR™ is ideal for drug manufacturers aiming to bridge the gap between R&D and GMP clinical batch production, ensuring scalability and maintaining key process parameters across all scales.
Benefits
- Facilitates reliable microsphere scale-up from R&D to full production
- Ensures consistent product yield and batch integrity with reduced waste
- Supports various drying and de-watering methods, including freeze-drying
- Real-time quality monitoring with PAT verification
- Versatile for multiple products and applications