title: Harnessing QbD, Programming Languages, and Automation for Reproducible Biology.
abstract: Building robust manufacturing processes from biological components is a task that is highly complex and requires sophisticated tools to describe processes, inputs, and measurements and administrate management of knowledge, data, and materials. We argue that for bioengineering to fully access biological potential, it will require application of statistically designed experiments to derive detailed empirical models of underlying systems. This requires execution of large-scale structured experimentation for which laboratory automation is necessary. This requires development of expressive, high-level languages that allow reusability of protocols, characterization of their reliability, and a change in focus from implementation details to functional properties. We review recent developments in these areas and identify what we believe is an exciting trend that promises to revolutionize biotechnology.
authors.affiliation: Synthace Limited, London Bioscience Innovation Centre, 2 Royal College St, London NW1 0NH, UK.
authors.forename: Michael I
authors.initials: MI
authors.lastname: Sadowski
authors.affiliation: Synthace Limited, London Bioscience Innovation Centre, 2 Royal College St, London NW1 0NH, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Grant
authors.affiliation: Synthace Limited, London Bioscience Innovation Centre, 2 Royal College St, London NW1 0NH, UK. Electronic address: t.fell@synthace.com.
authors.forename: Tim S
authors.initials: TS
authors.lastname: Fell
mesh_terms: D057005:Bioengineering / Q000379:methods / Q000592:standards; D001709:Biotechnology / Q000379:methods / Q000592:standards; D011381:Programming Languages; D015203:Reproducibility of Results
keywords: complexity; design of experiments; laboratory automation; programming languages; quality by design; reproducibility