The contract manufacturing organisation (CMO) will produce a peptide-protein conjugate for Axon Neuroscience’s Alzheimer disease candidate which is entering Phase I clinical trials in Europe.
Dr. José Pierre de Chastonay, Chief Marketing Officer at Bachem, told this publication the deal “is meant to be a long term collaboration in which [Bachem accompanies] the company through their clinical trial program and hopefully supply commercial quantities should the drug be approved.”
No financial terms were divulged but details of the contract include the use of Bachem’s Clinifa sterile peptide platform manufactured at its plant in Weil am Rhein, Germany where, according to Dr. de Chastonay, Bachem “has the technical capabilities and infrastructure to make peptide Active Pharmaceutical Ingredients (API) very competitively.”
Another reason Axon selected Bachem was - according to Chastonay - the CMO's ability to perform “conjugations of peptides to proteins” and make “sterile dosage forms for early phase clinical trials” without using any other companies.
Peptide API Manufacture
According to one expert at this year’s Informex, about 50% of all clinical trials are currently dealing with APIs made of up nucleosides, peptides and carbohydrates. Subramaniam Arumugam, CEO of India-based CMO ArudaaVis, told Outsourcing-Pharma.com that many CMOs have shifted their focus in the last few years to more complex manufacturing.
According to de Chastonay, Bachem – who he says is the largest peptide contract manufacturer – the complexities involved in the manufacture of peptide APIs “is in stark contrast to the few steps required to make small molecule APIs,” with “many processing steps – often in the hundreds - from start to finish.”
Furthermore, he added, the purification stage is “more tedious since many impurities are generated during primary manufacture,” and analytical methodology is also more complex than with smaller molecule drugs.