Hans Baumeister, Division Manager Service
Glycotope, a renowned clinical-stage immuno-oncology company, has been playing a crucial role in the development of innovative mAb and non-mAb-based therapeutics in immuno-oncology and other areas. Backed by exceptional glycobiology expertise, Glycotope provides a wide range of services in the biopharmaceutical space related to cell line and process development, instrumental bioanalytic, clinical immunomonitoring, and cellular assays.
Taking advantage of expertise in the development of Glycotope´s in house biopharmaceutical projects Glycotope has recently established a new branch dedicated to services to offer this expertise and its GEX® technology to other companies. The branch is run by Lars Stöckl and Hans Baumeister both being with Glycotope for more than 15 years and acting as division managers for the Service branch at Glycotope.
Cell line development
With almost two decades of experience in cell line development, Glycotope provides
• Cell line development in CHO, SP2/0 as well as other well-known cell lines as well as
• Cell line development in GlycoExpress® (GEX®) cells: A toolbox of human cells for the high yield production of human glycoproteins.
In some cases, CHO or other widely used expression systems do not produce either enough protein or protein in sufficient quality. To address this problem, Glycotope has carved a niche for itself in providing the GEX® technology, a well-established and characterized human expression technology platform for all proteins. “For difficult to express proteins and highly complex proteins, we often see that the GEX® technology provides much better productivities than CHO cells,” says Lars Stöckl. Also, the platform allows the optimization of glycosylation to improve the product.
The company can execute the complete preclinical work packages of cell line development, upstream and downstream process development and product analytics for transferring the process to a GMP facility.
Peptide and PTM-analytics with special emphasis on Glyco- Analytics
To evaluate and realize the full therapeutic potential, Glycotope offers a broad range of state-of-the-art peptide and glyco-analytical technologies to streamline process development and to fully characterize produced batches.
Dr Lars Stöckl, Division Manager Service
“With our GlycoFiler technology we provide a fast and reliable technique to detect key glyco-structures at an early stage of cell cloning, hence avoiding the time-consuming ‘back and forth’ of cell cloning, expansion and product characterization,” says Lars Stöckl.
During GMP production, the clinical immunomonitoring team gets active. Assays are developed to analyze the pharmacokinetic and pharmacodynamic characteristics of the drug as well as assays to assess the immunogenicity. For clinical application, all assays are validated according to the current FDA and EMA guidelines. To ensure the necessary quality, Glycotope follows the “Good Clinical Laboratory Practice” (GCLP).
The Glycotope team is fond of complex cell-based, immunological assays using various technologies that help to meet the requirements, especially of immune-oncological drugs. Clients often leverage this in preclinical research and later on for PD marker analysis during clinical development, explained Hans Baumeister.
Hans Baumeister continues “The key differentiating features of Glycotope is its ability to combine preclinical and clinical proficiency while providing CHO based technologies along with GEX® platform to achieve success in biopharmaceutical space.”
To better highlight Glycotope’s unique value proposition, Lars Stöckl highlights a case scenario where Glycotope assisted a US-based company that was struggling with their CHO clone development. Through its GEX® technology, Glycotope helped client overcome the development issues and supported them to execute GMP production in their US facility.
Looking beyond Glycotope’s best-in-class services, the duo, however, credits the company’s success to its excellence in customer communication and adept project management skills. In conclusion, Hans Baumeister says, “At Glycotope, we maintain the highest standards in our services, which is why our clients have placed their trust and confidence in our processes.”