Our work is defined by results that withstand audits, regulatory review, and time. With 45+ CMC development programs completed, 6+ biologics supported through EMA/FDA approval, and 15+ molecules in clinical development, our track record reflects robust scientific practice and a structured CMC framework across molecule classes and host systems. These outcomes reflect the unified scientific and quality framework described in Why Glycothera.
Our experience spans molecules, systems, and development workflows — always executed within one aligned scientific and quality approach.
A selection of anonymized project studies illustrating the breadth and depth of our work — spanning molecule classes, expression systems, development timelines, and regulatory outcomes.
Host: CHO-GS (33-CHO-GS)
Host: CHO-GS (33-CHO-GS)
Host: CHO-GS (33-CHO-GS)
Host: CHO-K1
Since 1998, Glycothera has evolved from two specialized development units into an independent CDMO with integrated sites in Julich and Hanover. Each phase strengthened how we design, execute, and document CMC programs — defining the scientific and quality framework we work with today.
Founded in 1998, Glycothera began with a strong scientific focus on cell line development, upstream processes, and molecular characterization. Early work on stability, productivity, and analytical fingerprinting established the disciplined CMC mindset that continues to guide our work.
Following its scientific beginnings, Glycothera became part of Alvotech, bringing the teams in Julich and Hanover under one organizational structure. This integration unified scientific standards, documentation practices, and analytical expectations — an important step toward today’s coordinated development approach.
During this period, Julich strengthened its expertise in cell line development and upstream processes — drawing on experience from predecessor units such as Baliopharm and Celonic — while Hanover established GMP-aligned analytical frameworks and release-relevant systems. Together, both sites formed the scientific and quality foundation that underpins Glycothera today.
Across 45+ CMC development programs, the teams gained experience with IgG1, IgG2, IgG4, and bispecific antibody formats, Fc-fusion proteins, glycohormones, and recombinant cytokines — developed in CHO, SP2/0, and NS0 systems. These programs refined the reproducible workflows and analytical depth we apply today.
6+ biologics advanced through EMA/FDA approval with analytical and development contributions from Glycothera — demonstrating the consistency of our scientific execution and structured CMC development.
In 2025, Glycothera was relaunched as an independent CDMO, opening its established capabilities to external partners. Julich now leads cell line and process development, while Hanover delivers analytical depth and GMP-ready release testing — aligned through one unified scientific and quality system.
Unified documentation, coordinated workflows, and aligned quality standards created a seamless cross-site environment that enables coherent CMC development from first cell line to release analytics.
Glycothera continues to deepen analytical capabilities, refine process robustness, and extend its integrated CMC approach — shaping future biologics with clarity and precision.
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