title: Scalable Technology for the Extraction of Pharmaceutics (STEP): the transition from academic knowhow to industrial reality.
abstract: 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 £1.5 m 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.
authors.affiliation: Brunel Institute for Bioengineering, Brunel University, Uxbridge UB83PH, UK. ian.sutherland@brunel.ac.uk
authors.forename: Ian
authors.initials: I
authors.lastname: Sutherland
authors.forename: Svetlana
authors.initials: S
authors.lastname: Ignatova
authors.forename: Peter
authors.initials: P
authors.lastname: Hewitson
authors.forename: Lee
authors.initials: L
authors.lastname: Janaway
authors.forename: Philip
authors.initials: P
authors.lastname: Wood
authors.forename: Neil
authors.initials: N
authors.lastname: Edwards
authors.forename: Guy
authors.initials: G
authors.lastname: Harris
authors.forename: Hacer
authors.initials: H
authors.lastname: Guzlek
authors.forename: David
authors.initials: D
authors.lastname: Keay
authors.forename: Keith
authors.initials: K
authors.lastname: Freebairn
authors.forename: David
authors.initials: D
authors.lastname: Johns
authors.forename: Nathalie
authors.initials: N
authors.lastname: Douillet
authors.forename: Chris
authors.initials: C
authors.lastname: Thickitt
authors.forename: Elsa
authors.initials: E
authors.lastname: Vilminot
authors.forename: Ben
authors.initials: B
authors.lastname: Mathews
mesh_terms: D001709:Biotechnology; D003377:Countercurrent Distribution / Q000266:history / Q000379:methods*; D004345:Drug Industry / Q000266:history / Q000379:methods*; D049673:History, 20th Century; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000302:isolation & purification*; D012106:Research / Q000266:history; D013237:Stereoisomerism
chemical_list: D004364:Pharmaceutical Preparations