Glycothera brings together scientific depth, structured CMC thinking, and a quality-driven mindset shaped by long-standing GMP practice — with a clear focus on building development programs that are regulatory-ready and prepared for market progression. With a proven record across cell line development, process development, and analytics, we operate within one unified scientific and quality framework.
Our experience spans 45+ CMC development programs, 6+ biologics supported through EMA/FDA approval, and 15+ molecules in clinical development — covering antibodies (IgG1, IgG2, IgG4, and bispecific formats), Fc-fusion proteins, glycohormones, cytokines, enzymes, and clotting factor, and multiple host systems including CHO, SP2/0, and NS0.
Our mindset is grounded in solid scientific principles and a clear understanding of CMC requirements. We value precision over assumptions, transparent data over shortcuts, and decisions backed by sound reasoning.
This discipline shapes every project and is reflected in the consistent results documented in our track record and unified scientific and quality framework.
We make complex CMC development predictable. Cell line development, process development, and analytics operate within one unified scientific and quality framework, ensuring aligned data, traceable documentation, and well-grounded CMC decisions.
This integrated structure is reflected in the reproducible workflows documented in our track record.
Our teams in Julich and Hanover work within a shared scientific and quality infrastructure. Together, they create a seamless environment for integrated CMC development.
Julich unites cell line and process development within a structured documentation workflow. Its close integration with analytics ensures that development decisions align early and remain consistent across phases.
Hanover hosts our analytical and GMP-centered operations, including physicochemical characterization, method development, stability programs, and release-relevant data packages. Qualified methods and structured documentation support regulatory compliance across characterization activities and through batch release.
Berkan leads Glycothera’s strategic and operational direction. With 15+ years of experience in biologics, cell & gene therapy, and consulting, he combines scientific insight with a business perspective.
Verena brings almost two decades of experience in biosimilar and recombinant protein development — building processes that are robust, scalable, and meeting regulatory expectations.
Tobias leads Glycothera’s Quality Unit, establishing robust systems and reliable processes. With 15+ years in pharmaceutical quality and GMP compliance, he strengthens regulatory confidence and supports successful approvals.
Iris shapes a culture built on trust, professionalism, and teamwork — based on 25+ years in biotech and pharma environments.
Nicolas oversees physicochemical characterization and analytical method development, bringing deep expertise in analytical chemistry and comparability studies.
Arndt-René contributes 25+ years of expertise in drug discovery, protein engineering, and cell line development — bringing nuance and depth to complex scientific programs.
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