Recent advances in innovation and discovery of substances that prevent, cure or control diseases in humans and animals are unparalleled. The term biomolecules, biotechnologies, bioengineering, biopharmaceuticals and the like have been used to refer to and describe such substances. Strictly applied, bio-substances, bio-molecules and biotechnology involve use of live organisms and are biological in nature.

After research, development and bench testing of “biomolecules” comes the phase of producing them on a commercial scale for sale to consumers. The scale-up of bench production, engineering, regulatory permitting and compliance, design, construction and, operation of bio-production plants present totally different challenges from the research and development phase. Successful management of commercial scale capital projects for bio plants is therefore most critical to realize intended production, timeliness of delivering the product to the market, meeting compliance and, by no means least, yielding financial gains and profits.

This paper describes the necessary steps and their progression required to meet the challenges of successfully designing, building and commissioning bio production plants. A case study involving the engineering, design and construction of a commercial scale bio plant as well as lessons learned will be presented.

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