Cell Line Development
Stable cell line establishment and clone selection for antibody and antibody-based modalities.
SERVICES · CDMO
Contract Development & Manufacturing
End-to-end antibody contract development and manufacturing — from cell line development to GMP clinical supply — backed by two decades of in-house antibody drug development.
Scale
50 L + 200 L GMP
Scope
Cell line → GMP supply
Clinical
Phase 1 supply-ready
Site
Single-site, New Taipei
01 — Overview
Antibody CDMO from an Integrated Drug Development Organization
GlycoNex provides contract development and manufacturing (CDMO) services for monoclonal antibodies and antibody-based therapeutics through the same integrated organization that develops its own clinical-stage biologics. Our end-to-end capabilities span cell line development, upstream and downstream process development, analytical method development, formulation development, GMP-compliant manufacturing, and technology transfer, supporting programs from early development through Phase 1 clinical supply.
Manufacturing is performed at GlycoNex's GMP-compliant facility, which supports 50 L pilot-scale and 200 L GMP-compliant manufacturing for clinical-stage antibody production. Because our CDMO services are built on the same platform used to advance our own pipeline, clients benefit from integrated development, efficient knowledge transfer, and development teams with firsthand experience in advancing biologics from discovery to the clinic.
02 — Capabilities
Services Across the Antibody Development Workflow
Process Development & Scale-Up
Upstream and downstream process development, optimization, and scale-up.
GMP-Compliant Manufacturing
GMP-compliant antibody production at 50 L and 200 L scale, supporting Phase 1 clinical supply.
Technology Transfer
Structured technology transfer and project management across the development-to-manufacturing workflow.
03 — Integrated Glycan Analytical Platform
Comprehensive Analytical Platform for Antibodies and ADCs
GlycoNex has established a comprehensive in-house analytical platform to support the development, characterization, and quality control of monoclonal antibodies and antibody–drug conjugates. The platform covers identity, purity, charge variants, molecular size, primary and higher-order structure, biological activity, glycosylation, process- and product-related impurities, and safety-related attributes.
For ADC programs, additional capabilities support the characterization of conjugation-related quality attributes, including drug-to-antibody ratio, free drug, aggregation, and product heterogeneity. These integrated analytical capabilities enable close linkage between process development and product quality, supporting comparability assessment, formulation and process optimization, method development, and clinical-stage manufacturing.
Purity & Charge
- SEC-HPLC
- CIEX / AEX-HPLC
- SDS-PAGE
- CE-SDS
- RP-HPLC
- cIEF
Protein Content
- Protein A-HPLC
- A280
Potency & Binding
- Affinity ELISA
- SPR
- ADCC / CDC
- Cell-based assays
Primary Structure
- Intact-protein MS
- Peptide mapping
- PTM profiling
Higher-Order Structure
- Free-thiol
- Disulfide-bond mapping
- CD
- DSC
Glycosylation
- Glycosylation-site analysis
- N-glycan profiling
- Monosaccharide composition
Impurity & Safety
- Endotoxin
- Bioburden
- Sterility
- Residual Protein A
- Host-cell protein
- Host-cell DNA
04 — Why GlycoNex
What Sets the CDMO Apart
Vertically integrated
A single-site organization spanning antibody discovery, process development, GMP production, and quality management.
Development Expertise That Reduces Risk
Practical experience across antibody development, scale-up, GMP-compliant manufacturing, and clinical supply helps anticipate technical challenges and support efficient program execution.
Glycan & biosimilar analytical depth
Specialized glycan characterization supporting comparability and quality for complex antibody programs.
Demonstrated track record
Contract programs delivered for external biotechnology partners, including a published neurodegenerative-disease antibody collaboration.
05 — Selected Engagement
Recent Contract Program
In December 2025, GlycoNex entered a contract development and manufacturing agreement with Change Cure, a spin-off from Institute of Science Tokyo, for CC001 — an HMGB1-targeted antibody program for frontotemporal lobar degeneration (FTLD), a neurodegenerative indication. GlycoNex also provides contract services to additional biotechnology companies in Taiwan whose engagements remain confidential.