Projects

•          Summary

We plan to develop small footprint, versatile, counter-current chromatography purification technology and methodology which can be operated at a range of scales in both batch and continuous modes and that can be inserted into existing process plant and systems.  The consortium will address major production challenges aiming to provide a flexible, low capital capability driving substantial cost efficiency in both drug development and drug manufacturing processes.

•          Intention

–         Develop a “plug & play” High Performance Counter Current Extraction (HPCCE) processing system

–         new processing and production techniques for material isolation and purification

–        provide a key commercial platform technology for the future

•          Objectives

–         Step-change in speed & scale-up of isolations

–         Generate a portfolio of practical applications at various scales

–         Demonstrate reduction in processing complexity and cost

–         Develop and integrate robust, easy to use systems

•          Approach

–         Align the technology to the pharmaceutical industry

–         End-user driven development of the technology

–         Encourage broader industry uptake

•          Phases

–         Phase 1 – Application of HPCCE to end-user problems

–         Phase 2 – Process integration at the lab/prep scale

–        Phase 3 – Design of fully integrated, automated industrial scale HPCCE manufacturing process for industrial installation

•          Justification

As development projects move to the Kg and multikilogram scale use of Prep Chromatography is frequently limited due to the costs associated with equipment and materials. Counter Current Chromatography (CCC) has the potential to reduce these costs through a reduction in the amount of solvent required per Kg of material purified and by the elimination of solid stationary phase.

Next week, 10 to 13th July, at Prep 2011 – 24th International Symposium at the Hyatt Hotel a further project update on the progress of the STEP project will be given. This will cover the period since the last update at SPICA ’10 in Stockholm. 

The project is developing a small footprint, versatile, purification instrumentation and methodology which can be operated seamlessly at a range of scales, from laboratory to kilo/pilot scale in both batch and continuous modes. The consortium will address major production challenges aiming to provide a flexible, low capital capability driving substantial cost efficiency in both drug development and drug manufacturing processes. 

The project involves the use of the liquid-liquid separation technique – High-Performance Counter Current Chromatography (HPCCC) - and the instrumentation is being developed by a consortium involving  Dynamic Extractions, GlaxoSmithKline, Pfizer and Brunel University.