Pharma Focus Asia

Ginkgo Bioworks Announces Collaboration with Merck to Improve Active Pharmaceutical Ingredient Manufacturing

Wednesday, October 12, 2022

Ginkgo Bioworks, the leading horizontal platform for cell programming, today announced a collaboration with Merck, known as MSD outside the United States and Canada, to engineer up to four enzymes for use as biocatalysts in Merck's active pharmaceutical ingredient (API) manufacturing efforts. Through this collaboration, Ginkgo will leverage its extensive experience in cell engineering and enzyme design, as well as its capabilities in automated high throughput screening, manufacturing process development/optimization, bioinformatics and analytics to deliver optimal strains for expression of targeted biocatalysts.

Biocatalysis is a sustainable and often more effective alternative to some chemical synthesis steps in industrial chemical synthesis. The inherent stereospecificity of enzyme biocatalysts can reduce costly synthesis and purification steps, thereby decreasing production costs. Through this collaboration, Ginkgo aims to optimize several biocatalysts by leveraging its world-class proprietary fungal strains, cell line development, enzyme engineering and optimization, and multiomics expertise.

"Ginkgo's fungal strains present a major opportunity for improving biocatalysis. E. coli is currently the mainstay host for expressing enzymes, but a large number of enzymes will not express properly in E. coli, and those that do express in E. coli may have better homologs that only express in fungal strains," said Behzad Mahdavi, Senior Vice President of Biopharma Manufacturing and Life Sciences Tools at Ginkgo. "This enzyme optimization project with Merck has the potential to help reduce the cost of goods and enable a more robust supply chain for APIs."

"Merck is a pioneer in biocatalysis, improving manufacturing of crucial medicines. We're thrilled to be partnering with Merck, and to be leveraging our platform capabilities for improved enzyme activity and production" said Jason Kelly, co-founder and CEO at Ginkgo. "Ginkgo's platform model enables us to identify improved enzymes and develop powerful fungal strains and fermentation processes for enzyme manufacturing, empowering downstream API production for our customers."

Under the terms of the collaboration, Ginkgo will earn an upfront research and development fee and is eligible for success-based research and development milestone payments. In addition, Ginkgo is eligible to earn commercial milestone payments for each of a specified number of biocatalysis targets, which have the potential to total, in the aggregate, up to $144 million.

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