Mechatronic design methodology for biotechnology products

Abstract

Biotechnology products can be divided into (1) biologics, which comprise those metabolites, biopolymers, and cell structures that are produced through biological processes, and (2) biotechnical machines, which are apparatuses and devices that transform, change, or analyze ‘biological specimens’ for specific purposes, often by using the biological systems per se. The first category has been thoroughly treated in bioengineering theory and practice while the second has been very scarcely investigated.In this presentation is described how the general design science theory can be applied when designing a technical system where biological species or components have the key role in the engineering design solutions. We have named these systems bio-mechatronic systems, since they are combined design achievements between traditional electronic and mechanical sub-systems and the biological systems, and where biological molecules and/or active microbial or cellular components influence the design solutions in a complex way.The purpose is to demonstrate that biotechnology and bioengineering related design can utilize and benefit from other commonly used design tools in, for example, mechanical and electric engineering. These tools should result in shorter development times and a reduction of the need for prototype testing and verification.Four examples will be presented, all well-known biotechnology products in the pharmaceutical and clinical areas: (1) a protein purification system, (2) a bioreactor system, (3) a biosensor instrument, and (4) an embryonic stem cell manufacturing systems.