For almost 20 years, Kymos’ German subsidiary Prolytic has accompanied Aeterna Zentaris in its development of pharmaceutical and diagnostic products. Katrin Dorfmeyer, Head of Chromatography, at Prolytic, and Dr. Michael Teifel, CSO at Aeterna Zentaris, shed light on the interesting project of the growth hormone secretagogue macimorelin (Macrilen, Ghryvelin) which they have been working on together for the last 10 years.

Katrin Dorfmeyer begins with an explanation of why pharmaceutical and biotech companies in general turn to Prolytic: “We at Prolytic are known as specialist in chromatography namely bioanalysis of small molecules with LC-MS/MS. In the past our clients mostly contacted us with specific and difficult analytical projects because they knew that we would find a solution for them. In the case of Aeterna Zentaris, we started our first investigations in 2003 with the then state of the art RIA method but managed to develop an innovative LC-MS/MS method, which no one had accomplished before.”

Dr. Teifel also recalls the close relationship Aeterna Zentaris and Prolytic have: “Over the years, Prolytic has supported us in many different projects with various analytes, including small molecules, peptidomimetics, peptides and peptide-drug conjugates. For the macimorelin project, we have been working with Prolytic for almost two decades now. Macimorelin (Macrilen, Ghryvelin) is the first and only U.S. FDA and EU approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). With our ongoing studies in children and adolescents we aim to make this test option also available in this population. Once again, Katrin Dorfmeyer’s team supports us with its excellent LC-MS/MS analytical expertise.”

Katrin Dorfmeyer elaborates further: “As already mentioned, many clients have come to us in the past for complicated special cases. Since we merged with Kymos in 2020, more and more clients are also turning to us for large pre-clinical and clinical trials, which we now can handle routinely and quickly. Together with Kymos in Barcelona and Pharmaprogress in Ancona, we have three API-6500 two of them coupled to an Agilent UHPLC, two high-sensitivity APIs 5500 connected to a Waters UPLC Acquity, six API-4000 and one API-3200 (all triple SCIEX quadrupoles). We are now capable of processing more than 31,000 bioanalytical samples per month.”

Volume capabilities aside, Prolytic is still ready to tackle extremely complex topics. Katrin Dorfmeyer refers to our newest project: “In our BMBF-funded research project, we recently succeeded in developing an LC-MS/MS method for the determination of prostaglandins in urine. Prostaglandins are extremely complicated to detect as endogenous markers due to their instability and difficult chromatographic separability. By means of a special solid phase extraction and a new standardisation procedure developed by our team, we were able to validate the LC-MS/MS method according to GLP.”

“These scientific challenges motivate and inspire my team and me.” she continues. “Yet, it is at least as satisfying that, as is the case for macimorelin (Macrilen, Ghryvelin), we are privileged to be part of a project that ultimately made it to the market, and contributing to improving human health.”

 

Prolytic is part of the Kymos Group. Kymos is a GLP/GMP-certified, GCP-compliant, EMA and FDA-inspected European contract research organization specialized in bioanalysis and CMC. Find out more about Kymos’ services at www.kymos.com or contact us at commercial@kymos.com.

Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. Find out more about Aeterna Zentaris and its projects at https://www.zentaris.com/ or contact them at aezs@jtcir.com