Lisa Hentschel, Master of Molecular Biosciences, started her career at Prolytic eight years ago as a technician in the ELISA team. Since 2017, she now leads the Biology Department and is a recognized expert in large molecule bioanalysis, ADA determination and enzyme activity measurement. Together with Dr Busch, COO at Eleva, she shares her insight in the promising field of therapeutic enzymes. Lisa Hentschel starts at the beginning back in 2014:

“Eight years ago, Eleva, then still Greenovation, approached us with a specific problem that no one had been able to help them with until then. Instead of a non-specific quantification of their enzyme in plasma, they wanted to know how much active enzyme was present after administration.”

Dr Busch also recalls back to the situation Eleva was in at the time and why he approached Prolytic with their request:

“Some of the worst human genetic diseases are caused by missing enzymes. At Eleva, we have addressed this problem using an incredibly efficient tool: Bryophyta, more commonly known as moss. From this we extract alpha-galactosidase and other enzymes and use them for our enzyme replacement therapies. To assess whether our enzymes can work, we need to determine not only how much enzyme is in the blood, but also whether it or how much of it is active. Unfortunately, we couldn’t find anyone who could determine that for us under GLP and finally turned to Prolytic.”

Lisa Hentschel continues the story: “That was the birth of our specialized assays for enzyme activity measurement. A method was available at Eleva, but validation under GLP was a challenge because there was no guideline for this particular case. Therefore, my team and I developed a validation scheme oriented to the Bioanalytical Method Validation Guidance for Industry for Ligand Binding Assay (LBA).”

Since then, the Biology Department has developed and validated activity assays for multiple enzymes from different clients, successively expanding and professionalizing their knowledge and experience. However, Lisa Hentschel’s team does not only deal with enzyme activity: The bioanalytical analysis of large molecules by ELISA is as much a part of their field of expertise as Anti-Drug Antibodies determination (ADA). Since Prolytic became part of the Kymos Group, even more assays became available, as Lisa Hentschel explains:

“Customers had repeatedly asked us for further analytical services, which we could not offer as a small CRO. Together with our colleagues in Barcelona, we can now provide neutralization and cell binding assays in addition to our ADA services. Not to speak of the possibilities that arise from our GMP partner department “Quality Control of Biologics and Biosimilars”. This allows us to accompany our customers as Kymos Group beyond early development and into manufacturing, commercialization and beyond. I personally enjoy the exchange with my new colleagues, and we all benefit from each other’s experience.”

Furthermore, Lisa Hentschel is particularly satisfied about the close relationships she has been able to build with her clients over the years: “It’s especially fulfilling for us when we can support clients with their projects and help them move forward. And we are particularly pleased when they then return to us again and again. This is what happened with Eleva, who we are currently assisting with yet another project.”

Dr Busch underlines this statement by adding: “For us it was clear that we would like to work with Lisa and her team on further projects. Her willingness to adapt to our wishes and to venture into unknown territory, but also her wealth of knowledge in the bioanalysis of enzymes make her a perfect partner for us.”

Both enzyme specialists are excited about the promising future of the enzyme replacement therapy market, which according to Allied Marketing Research is expected to double in volume over the next 10 years. This promises that many interesting enzyme projects will be sure to come at both Prolytic and Eleva.

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 on commercial@kymos.com.

Based in Freiburg, Germany, Eleva develops novel biological therapies with its pharmaceutical partners. The privately-held company leverages its unique moss-based production platform to produce supreme biologics like antibodies, replacement enzymes, or complement regulating proteins. Eleva has successfully developed drug candidates into clinical phases. Find more information on www.elevabiologics.com or contact on hello@elevabiologics.com.