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 antibody and antibody-based therapeutics, drawing on the same integrated organization that develops its own clinical-stage ADCs and biosimilars. Capabilities span cell line development; upstream, midstream, and downstream process development and optimization; scale-up; GMP manufacturing; and technology transfer. Manufacturing is supported by GMP-compliant antibody production at 50-liter intermediate and 200-liter production scale at the company's New Taipei City facility, capable of supplying Phase 1 clinical material. Contract development and manufacturing services form a deliberate part of GlycoNex's business model, providing a recurring revenue stream alongside its proprietary drug development programs.

02 — Capabilities

Services Across the Antibody Development Workflow

01

Cell Line Development

Stable cell line establishment and clone selection for antibody and antibody-based modalities.

02

Process Development & Scale-Up

Upstream, midstream, and downstream process development, optimization, and scale-up.

03

GMP Manufacturing

GMP-compliant antibody production at 50 L and 200 L scale, supporting Phase 1 clinical supply.

04

Technology Transfer

Structured technology transfer and project management across the development-to-manufacturing workflow.

03 — Integrated Glycan Analytical Platform

Comprehensive Antibody Characterization, with Deep Glycan Analytics

Glycosylation is a defining quality attribute for antibody therapeutics — and the area where GlycoNex's glycan-science heritage runs deepest. Our in-house laboratory resolves glycan structure, glycoform composition, and lot-to-lot consistency in detail, as one part of a complete characterization panel that spans identity, purity and charge, potency, primary and higher-order structure, and impurity and safety testing. For biosimilar programs, glycoform composition and consistency are central comparability attributes; for novel antibodies and ADCs, the same analytical depth ties process development directly to product quality.

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

01

Vertically integrated

A single-site organization spanning antibody discovery, process development, GMP production, and quality management.

02

Backed by an active pipeline

The teams supporting external programs also develop GlycoNex's own clinical-stage ADCs and biosimilars.

03

Glycan & biosimilar analytical depth

Specialized glycan characterization supporting comparability and quality for complex antibody programs.

04

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.

Exploring a development or manufacturing partner?

GlycoNex welcomes inquiries from companies seeking antibody process development, GMP manufacturing, or analytical support. Please indicate "CDMO Inquiry" in the subject line.

Contact our CDMO team →
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