Implementation of Industry 4.0 Concepts for Manufacturing of Oligonucleotides and Peptides

Main Conference, Day 2, Session "CMC Strategies for Oligonucleotides and Peptides", 1:45pm - 2:15pm

Industry 4.0, or the fourth industrial revolution, refers to the automation and digitalization of traditional industrial processes through smart technology and integration. The “smart factory” concept within Industry 4.0 depicts a state of interconnected and interoperable machines, which are able to process data autonomously and act with very limited human decision making or intervention. The presentation will give an overview and examples about Industry 4.0 concepts along the typical manufacturing processes for TIDES drug substances at Bachem.

Daniel Samson

VP Head Oligonucleotides

Daniel brings 15 years of industry experience to the team, with an emphasis on TIDES process R&D, manufacturing and CMC development. He leads Bachem’s oligonucleotide unit including innovation projects, R&D and manufacturing activities. Daniel holds a PhD in organic chemistry from the University of Konstanz, and an MBA from the International Institute for Management Development (IMD), Lausanne. In previous stages of his career he was a lab head for process optimization, technology transfer, Quality by Design, and scale-up of synthetic peptide manufacturing procedures. From 2012, Daniel was a Vice President API Manufacturing and had full responsibility for all large-scale solid phase peptide and oligonucleotide syntheses, downstream operations, and CMC activities within Bachem AG.

CMC Development of Peptides, A Case Study

Main Conference, Day 2, Session "CMC Strategies for Oligonucleotides and Peptides", 4:15pm - 4:45pm

An effective CMC strategy for any peptide API should include risk mitigation approaches suitable for the intended clinical or commercial phase. The development and technology transfer of a Peptide API process (e.g. Lanreotide) will be presented as a case study in tailoring projects to specific regulatory routes or applications.

Christopher Martin

Senior Director, Production

Chris has worked in the bio-organic chemistry field for 15 years. He holds a master’s degree in peptide chemistry from the University of Freiburg, a PhD in carbohydrate chemistry from the Max Planck Institute and a PostDoc at the Shanghai Institute of Organic Chemistry. Since 2016, Chris has been with Bachem, first in in Switzerland and now in the US. He leads manufacturing teams specialized in the development and GMP manufacture of peptide pharmaceuticals in all lifecycle stages, starting from early pre-clinical development, through process validation, all the way to commercial supply and generic manufacturing.