Services CMC Preparative Purification Capacity
Preparative Purification Capacity
When conventional isolation methods are not enough, preparative chromatography provides another route to obtain the material needed for development. BioDuro has laboratory, kilo-lab, and pilot-scale capabilities for both normal- and reverse-phase separations.
Applications range from impurity and product isolation at small scale to the purification of larger quantities as projects move through process development.
Preparative Purification & Chromatography
Different separation challenges call for different chromatography approaches. Laboratory systems are used for impurity and product isolation and for preparing milligram-scale samples, while larger platforms provide additional capacity for process development and scale-up.
Laboratory Scale
Preparative HPLC systems, including Waters 2545 and HanBon-50 platforms, are available for impurity and product isolation and milligram-scale sample preparation.
Kilo-Lab Scale
Dynamic axial compression chromatography provides both reverse- and normal-phase separation, with loading capacities of approximately 10–20 grams per injection and reverse-phase purification extending to several hundred grams.
Pilot Scale
Pilot-scale chromatography includes normal-phase and reverse-/normal-phase systems for larger separation requirements. Normal-phase equipment supports purification at up to 10 kg scale, while dynamic axial compression chromatography provides an additional option for both reverse- and normal-phase work.
Capabilities
- Impurity and product isolation
- Preparative HPLC
- Normal-phase chromatography
- Reverse-phase chromatography
- Dynamic axial compression chromatography
- Milligram- to pilot-scale purification
- Purification method development and scale-up
Part of Process R&D
Preparative purification sits within BioDuro’s broader Process R&D capabilities and can be used alongside route development, process optimization, impurity control, and subsequent scale-up into drug substance manufacturing.
Related Resources
Explore BioDuro’s integrated capabilities for route scouting, process optimization, purification, process safety, and manufacturing scale-up.