Fast life cycle assessment of synthetic chemistry (FLASC™) tool

Abstract

Background, Aim and Scope

There is a clear need for simple methodology to deliver metrics that may be used to determine and benchmark the ‘greenness’ or relative sustainability of synthetic processes for Active Pharmaceutical Ingredients (APIs). Such methodology and metrics should facilitate more informed and sustainable business choices. This capability is particularly important at an early stage in R&D development activities when route and processes are being selected and detailed environmental data are not available. FLASC™ (Fast Life cycle Assessment of Synthetic Chemistry) is a web-based tool and methodology designed to meet these requirements.

Materials and Methods

FLASC™ was developed from a detailed assessment of the cradle-to-gate life cycle environmental impacts associated with the manufacture of materials used in a typical pharmaceutical process.

Results

This paper describes the methodology used to develop FLASC™ and provides examples of the type of information and guidance FLASC™ provides.

Discussion

Both Hierarchical Cluster Analysis (HCA) and Principal Component Analysis (PCA) were used for the statistical analysis during the development of FLASC™. Benchmarking within the pharmaceutical industry and use of normalization for molecular complexity were also integrated to the tool.

Conclusions

FLASC™ represents an important part of the overall efforts of GlaxoSmithKline (GSK) to incorporate and maintain sustainable business practices for manufacture of APIs used in its pharmaceutical products.

Recommendations and Perspectives

This tool is not intended to assess waste from GSK operations nor solvent recovery and currently does not incorporate specific chemical-related health and safety data. However, these are already routinely assessed within GSK R&D at appropriate milestones and the use of FLASC™ is complementary to these evaluations.