Easy access to purified complex peptides on larger scales with the peptide easy clean technology – a liraglutide case study

Published on 21.12.2021

With a remarkable amount of peptide therapeutics already on the market and many more to come, there is an ongoing need to improve manufacturing scale and efficiency for a sustainable, global supply.

N. Berger, M. Kumar Muthyala, D. Sarma, K. Rustler, T. Bruckdorfer, R. Zitterbart

Chimica Oggi 2021; 39(6): 38-41

Abstract: With a remarkable amount of peptide therapeutics already on the market and many more to come, there is an ongoing need to improve manufacturing scale and efficiency for a sustainable, global supply. Especially the trend towards longer and modified peptides challenges manufacturers to meet quality specifications and scale requirements. For example, more orally available peptide drugs will enter the market requiring worldwide supply in ton-scale. Herein, we introduce an innovative route for the chemical synthesis combined with orthogonal Peptide Easy Clean (PEC)-purification of the blockbuster peptide drug liraglutide, a fatty acid-modified peptide. We demonstrate easy and seamless upscaling to gram-scale, rendering this manufacturing route an attractive way to produce complex peptides for R&D and potentially in multi-kg and ton scales. PEC-assisted manufacturing can significantly save downstream costs due to high productivity, high yield, and low solvent consumption.