Wednesday, June 25, 2008 - 2:00 PM
South American AB (Capital Hilton)
110

LCA and EHS Comparison of Biocatalytic and Chemical Pharmaceutical Synthesis: 7-ACA

Concepción Jiménez-González1, Richard K. Henderson1, David JC Constable1, Chris Preston2, and John Woodley3. (1) GlaxoSmithKline, Research Triangle Park, NC, (2) GlaxoSmithKline, Ulverston, Cumbria, United Kingdom, (3) Technical University of Denmark, Lyngby, Denmark

Recognition of the benefits of selective catalysis has resulted in the introduction of a considerable number of biocatalytic reactions into synthetic strategies for potential Active Pharmaceutical Ingredient (API) manufacture. In addition, conventional wisdom typically asserts that there are potentially considerable environmental improvements and cost reduction associated with the use of biocatalysis. However without a rigorous and quantitative comparison between more traditional chemical and newer biocatalytic routes, it remains merely a perceived benefit. The present research intends to fill this gap.

The main goal of this work was to estimate and compare the environment, health, safety and life cycle impacts of two synthetic methods used to produce the API 7-aminocephalosporic acid (7-ACA). The routes under study were a chemical synthetic process and a two-enzyme catalysed process both starting from the potassium salt of cephalosporin C.

The methodology employed for comparison was a Green Technology Comparison framework previously presented. This method compares EHS performance utilizing GlaxoSmithKline's (GSK) sustainability metrics, and incorporates a life cycle approach. The cradle-to-gate life cycle impact estimations were performed using GSK's Fast Life cycle Assessment of Synthetic Chemistry (FLASCTM) tool and the modular gate-to-gate methodology developed in partnership with North Carolina State University.

Results are presented that compare efficiency, environment, health, safety and life cycle metrics for the chemical and enzymatic routes, both when only looking at the process itself and when accounting for the cradle-to-gate environmental life cycle impacts.

This research represents one part of GSK's ongoing efforts to move towards more sustainable business practices, by investigating novel, greener processes for producing Active Pharmaceutical Ingredients and estimating and optimizing their life cycle impacts.