Marcus GrafView all speakers
As Director Operations for Synthetic Biology, Marcus Graf is responsible for the entire production of synthetic genes in Regensburg, Germany including all downstream services and biosecurity and biosafety compliance. This incorporates the ISO 9001:2008 certified processes of design, the syntheses and the quality control of genes, gene libraries and expression vectors as well as plasmid DNA production.
As cofounder of the previous GENEART AG, now fully owned by Lifetechnologies Inc, Marcus Graf achieved a double digit volume growth year over year in gene synthesis reaching more than 5.0M basepairs per month in output. He is also a founding member of the International Gene Synthesis Consortium (IGSC) that strives to set and constantly improve biosecurity standards of the gene synthesis industry. The ICGS companies together represent more than 80% of commercial gene synthesis capacity world-wide.
Gene synthesis at increasing scale is a foundational suite of technologies and capabilities, advancing diverse research and industrial applications in synthetic biology engineering of living systems. Gene synthesis is a typical “dual-use” technology, simultaneously applicable for greater good and fulfillment of the promise of synthetic biology while potentially misused or intentionally designed for nefarious purposes. As current national and global guidelines, regulations or oversight are either in early development or don’t yet exist, awareness among community stakeholders regarding dual-use issues and the related need for effective biosecurity protocols is high. The leading synthetic gene providers proactively formed the IGSC in 2009, developing and implementing “The Harmonized Protocol”, a common parameter set for sequence homology-based gene order screening and customer information analysis among IGSC member companies. The Harmonized Protocol was in large part mirrored in the development of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNAb published in 2010. Since this time, membership in the IGSC has grown and the consortium enjoys continued regular engagement and collaboration among its members and with regulatory, policy, enforcement and academic stakeholders across and beyond the synthetic biology community. The common tools and implemented biosecurity screening processes used by the IGSC for compliance with national law, including export control regulations and international guidelines will be described. Development and implementation of a common and shared biosecurity sequence database and flag alert system operating in the context of member companies’ order process and supporting decision guidance by safety officers and informaticians to effectively resolve a concern sequence order or customer profile will be presented.