CordenPharma Collaborates with PeptiSystems

Due to the promising, yet underutilized potential of green chemistry and continuous manufacturing synthesis approaches gaining traction in the wider pharmaceutical community, CordenPharma is collaborating with PeptiSystems, a Swedish-based developer of instruments for peptide and oligonucleotide therapeutic process development and manufacturing based on flow through column technology. Because producing multi 100kgs of peptides per year using state-of-art-manufacturing technologies leads to an extensive amount of waste, the CordenPharma Peptide Center of Excellence in Frankfurt, Germany has introduced within their work stream PeptiSystems’ innovative solution to reduce the footprint impact and improve the Process Mass Intensity (PMI) of peptide manufacturing processes.

PeptiSystems is using an innovative concept that allows manufacturing of peptides in continuous mode, which reduces solvent consumption and corresponding waste by at least 40% in all peptides produced by Solid-Phase Peptide Synthesis (SPPS). In addition to improving the carbon footprint in peptide manufacturing, PeptiSystems’ continuous in-line monitoring also provides improved synthesis control and a more efficient manufacturing process. With this technology in place, the time taken for synthesis at large scale is expected to be reduced by as much as 50-90%, which will help to manage the growing demand for peptide-based pharmaceuticals.

“With the installation of PeptiSystems’ first innovative equipment in our R&D Peptide Center of Excellence in Germany, we are proud of this contribution towards reducing our Process Mass Intensity (PMI),” said Matthieu Giraud, director, global peptide, lipids and carbohydrates platforms, CordenPharma International. “This successful milestone represents one of our global initiatives to improve our footprint and reduce manufacturing costs.”

CordenPharma’s decision to collaborate in this space came from identifying a growing interest in therapeutic peptides within the pharmaceutical industry, as evidenced by the more than 80 peptide drugs on the market, of which ~150 are in clinical trials , and >400 in preclinical development.1 However, current peptide synthesis involves primarily legacy technologies that use large amounts of highly hazardous reagents and solvents, with little focus on green chemistry and engineering. Solvents represent the vast majority of the waste generated in chemical processes, and this is especially relevant for Solid-Phase Peptide Synthesis (SPPS). Hence, using greener solvents, or finding ways to reduce or recycle solvents, is of high interest. The waste cogeneration in peptide production has been reported to be in the multi-ton range for each kilogram of produced peptide2 vs hundreds of kilograms for small-molecule synthesis.3

Metrics are needed to quantify the impact of these new methodologies, be it within a pharmaceutical company or a contract development and manufacturing organization ( CDMO ). Which metric is best is more a question of organizational and personal preference. For CordenPharma, Process Mass Intensity (PMI) and E-Factor are currently the two most favorable.4 The Green Chemistry Institute Pharmaceutical Roundtable (GCIPR) selected PMI as their preferred mass-based green metric. When evaluating a process, solvents are usually the determining factor in the environmental impact, cost, and safety. Other reports have estimated that solvents can account for 50% of greenhouse gas emissions from the production of pharmaceuticals.5