Continuous manufacturing has led to a paradigm shift in the production of OSD and is being widely adopted by many companies including CDMO’s (contract development and manufacturing organizations) and generics manufacturers.
However, there are still some challenges that prevent CM being the go-to technology platform for low volume highly specialized potent drugs. Current methods for feeding and blending may not be suitable for running at low throughputs with very low share of active pharmaceutical ingredient (API).
Therefore, Gericke have developed a novel semi continuous feeding and blending process. This process also referred to as Mini Batch Blending combines the benefits of continuous manufacturing with the simplicity of a traditional batch process.
Mini Batch Blending
- Suitable for throughput rates below 1 kg/h and up to 20 kg/h without scale up
- Overall Batch sizes below 1 kg
- Suitable for drug loads below 1%
- Minimal use of API for process development especially during early phase development
- Simplify process control without start up or transient state
- Easy integration into existing process (e.g. tablet compression)
- Simplified control strategy without Residence Time Distribution RTD modelling
- Suitable for High Containment (OEB level 5)
The Gericke Mini Batch Blender is available as a standalone unit or fully integrated into the Gericke Formulation Skid (GFS) with Loss in Weight Feeders, Process Analytical Technology (PAT) and Material Handling.
Like all other Gericke equipment, these solutions are globally supported by the Gericke network of group companies and local partners. The Gericke test centres are available to select and verify the right mixing solution and the complete system setup. Furthermore, the Gericke Mini Batch Blender is available as a ental unit for on-site trials.