Scalable Technology for the Extraction of Pharmaceutics (STEP): The transition from academic knowhow to industrial reality
2011
Sutherland, Ian | Ignatova, Svetlana | Hewitson, Peter | Janaway, Lee | Wood, Philip | Edwards, Neil | Harris, Guy | Guzlek, Hacer | Keay, David | Freebairn, Keith | Johns, David | Douillet, Nathalie | Thickitt, Chris | Vilminot, Elsa | Mathews, Ben
This paper addresses the technological readiness of counter-current chromatography (CCC) instruments to become platform technology for the pharmaceutical industry. It charts the development of the prototype technology since its inception in 1966, through conceptual improvements in the 1980s that led to higher speed separations in hours as opposed to days. It then describes the engineering improvements that have led to the development of high performance counter-current chromatography with the potential for scale-up to process scale for manufacturing products in industry with separation times in minutes rather than hours. A new UK Technology Strategy Board high value manufacturing £1.5m research programme to take CCC through to technology readiness level 8 (i.e. as platform technology for continuous 24×7 operation by industry) is introduced. Four case studies are given as examples of successes from its expanding applications portfolio, which is mainly confidential. Finally, the hurdles for the uptake of new technology by industry are highlighted and the following potential solutions given: rapid method development, automation, continuous processing and instrument reliability and robustness. The future challenge for the CCC community will be to address these development needs urgently if CCC is to become the platform technology it deserves to be.
显示更多 [+] 显示较少 [-]