CMC development succeeds when science, documentation, and data flow together.
At Glycothera, cell line development, process development, and analytics operate within one unified scientific and quality framework — ensuring alignment from first clone to GMP readiness, across the molecule classes and expression systems we work with.
We focus on what development programs need most: stable cell lines, robust upstream processes, and analytical data that withstands audits and meets regulatory expectations.
All disciplines follow shared principles — reproducible workflows and traceable documentation across relevant expression systems and a broad range of biologics, including antibodies (IgG1, IgG2, IgG4, and bispecific formats), Fc-fusion proteins, glycohormones, enzymes, cytokines, and clotting factor.
Stable, high-producing cell lines — the scientific and regulatory foundation of successful biologics.
Robust, scalable upstream processes — consistent performance from bench to pilot.
Analytical depth and regulatory certainty — clarity from first characterization to GMP-ready testing.
Integrating CLD, PD, and analytical/GMP workflows ensures aligned data, well-grounded CMC decisions, and smooth transitions between development stages.
This structure mirrors the reproducible workflows demonstrated across our track record — from clone generation through regulatory approvals.
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