Performance Enzymes for Food Ingredients at the BIO World Congress—Enabling Biotechnologies and Supporting Capabilities Join in a Model for Successful Commercialization of Food Ingredients

T he educational program at the July 2017 Biotechnology Innovation Organization’s World Congress in Montreal included several panels on the rapidly evolving tool box in support of industrial biotechnology. One panel included representatives from many wellestablished names and early pioneers in synthetic biology (Twist Bioscience, South San Francisco, CA), protein engineering (Arzeda, Seattle, WA), biofoundries (Ginko Bioworks, Boston, MA) and CRISPR Cas9 (Estes Advisors) to discuss the new outsourced value chain that has emerged to assist especially smaller companies in their discovery and development efforts. Another panel—Performance Enzymes for Food Ingredients— discussed how the same tools are used by the enzyme industry in the discovery and development of enzymes tailored to new food applications and deployment of those enzymes in novel food applications. As members of the enzyme industry vary greatly in size AND in-house resources and capabilities, they rely to differing extents on the so-called outsourced value chain. Larger enzyme companies have established deep understanding and capabilities in protein engineering and the management of fermentation cell factories to develop and scale-up their process, but rely heavily on outsourced DNA sequencing and made-to-order synthetic DNA. Each of the Performance Enzymes panel speakers gave detailed presentations on their companies’ integrated suites of technical capabilities. Marc Struhalla discussed one-pot enzymatic synthesis of biomolecules by c-Lecta (Leipzig, Germany). Andrew Ellis of Biocatalysts (Cardiff, United Kingdom) discussed genome sequencing, protein engineering and highthroughput screening as put into practice by Biocatalysts, as did John Perkins (DSM, Parsippany, NJ) and Vince Sewalt (DuPont Industrial Biosciences, Palo Alto, CA). Chandrakant Rathi of Advanced Enzymes Technologies (Louiswadi, Thane, India) focused on his company’s efforts in application development for palm oil extraction, illustrating that biotechnology is directed toward solving very practical problems, anywhere in the world. The ensuing discussion led by panel moderator Vince Sewalt of DuPont focused on what panel members perceived to be the next bottlenecks in effective enzyme development and commercialization—including making sense of the abundance of sequence data and gene expression information, which will require Big Data capabilities. Another bottleneck identified for smaller companies was the development and continuous improvement of ‘‘cell factories’’ at full-scale fermentation volumes, a capability that today is limited to only the largest enzyme companies. In his introduction to the other speakers, Vince Sewalt also emphasized the need for additional commercialization capabilities that include safety assessment, regulatory approvals, and advocacy for science-based and risk-focused regulatory oversight, globally. In the discussion, it became abundantly clear that industry needs to collaborate in demonstrating product safety by using well-established safety evaluation methods. Such procedures focus on the safety of the production organism, in addition to addressing the enzyme, the manufacture process, supporting safety data, and a thorough exposure assessment (Fig. 1). Collectively, we can aid regulatory agencies in their assessment of our products by familiarizing them with the technology and the safety of the resulting food enzymes, which, if done in a consistent manner, results in knowledge-building among regulators. For example, the enzyme industry has produced numerous toxicology studies on enzymes from genetically engineered microbes (Pariza and Johnson), including for protein-engineered enzymes (as summarized by Pariza and Cook), and introduced the concept of Safe Strain Lineage to regulators. The latter builds on the repeated use of common production organism as our work horses, such as Bacillus subtilis, B. licheniformis, and Trichoderma reesei, and the optimization of these lineages into socalled ‘‘cell factories.’’ The knowledge built over multiple years and even decades for these production organisms includes a rich database of safety data, which supports Generally Recognized as Safe (GRAS) status of new enzymes when produced by members of a microbial lineage that has already been established as safe by repeated evaluation through standard, publicly recognized