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Antibody-Drug Conjugation Service

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Overview

Antibody–drug conjugates (ADCs) and next-generation antibody conjugates have rapidly become a leading class of targeted biologics, combining the molecular specificity of antibodies with highly potent payloads. With multiple global approvals and a fast-expanding clinical pipeline, ADCs are reshaping therapeutic strategies across oncology and immune-related diseases.

Unlike conventional monoclonal antibodies, ADCs are inherently multi-component systems. Their clinical performance is governed by the integrated control of antibody engineering, linker–payload chemistry, conjugation strategy, and manufacturing process consistency. Small variations in conjugation or process conditions can significantly affect drug-to-antibody ratio (DAR), stability, pharmacokinetics, and safety.

As the field advances toward site-specific conjugation technologies and next-generation antibody conjugates, regulatory expectations increasingly emphasize process understanding, critical quality attribute control, and CMC readiness. Successful ADC translation, therefore, depends on early, end-to-end integration of biologics, chemistry, analytics, and GMP-aligned manufacturing—making an experienced, cross-disciplinary CDMO partner essential.

One-Stop ADC CDMO Platform

Creative Biogene provides an integrated ADC platform covering antibody generation, linker–payload development, bioconjugation process engineering, GMP manufacturing, and pharmacodynamic evaluation. Our platform is designed to support both classical ADCs and emerging conjugate modalities within a unified quality and regulatory framework.

Platform Scope

Creative Biogene offers end-to-end ADC CDMO services from payload–linker synthesis to drug substance and drug product manufacturing, enabling seamless technology transfer and reduced development risk across discovery, IND-enabling, clinical, and commercial stages.

  • Antibody discovery and engineering
  • Cell line development

CMC & GMP Manufacturing

  • Comprehensive analytical characterization
  • Pharmacodynamic evaluation
  • Translational evaluation

Linker–Payload Platform

  • Site-specific & conventional conjugation

Antibody & Cell Platform

  • ADC DS & DP GMP manufacturing
  • Stability studies

Analytics & Translation

  • Linker–payload design and synthesis
  • GMP manufacturing of linker–payload

Conjugation Platform

Our Technical Capabilities

Our ADC platform integrates multidisciplinary expertise across chemistry, biologics, analytics and regulatory sciences.

Antibody Engineering and Biologics Manufacturing

High-quality conjugates start with developable antibodies. Our biologics platform integrates antibody engineering with downstream conjugation strategy design.

Capabilities

  • Recombinant monoclonal and bispecific antibody generation
  • Fc engineering for stability, PK, and effector modulation
  • Stable cell line development and upstream process optimization
  • GMP antibody drug substance manufacturing (200 L – 2,000 L scale)
  • Annual production planning aligned with clinical and commercial demand

Linker–Payload Development and High-Potency Manufacturing

Creative Biogene provides in-house linker–payload development and high-potency manufacturing infrastructure to support scalable ADC production.

capabilities

  • Custom linker and payload synthesis and functionalization
  • Cleavable and non-cleavable linker libraries
  • Site-selective (cysteine, lysine, glycan, enzymatic) conjugation strategies
  • High-potency API handling (OEB-5 / ng-level exposure control)
  • Manufacturing scale from milligram to kilogram

ADC Conjugation Process Development

Our conjugation platform is designed for reproducibility, DAR control, and regulatory-ready scale-up.

Process and manufacturing features:

  • Batch and semi-continuous conjugation workflows
  • Single-use and stainless-steel reactors
  • Drug-to-antibody ratio (DAR) optimization and distribution control
  • In-process control and batch release testing
  • GMP drug substance manufacturing with clinical and commercial scalability

Analytical Characterization and Quality Control Platform

Creative Biogene operates a dedicated ADC analytical platform aligned with ICH Q6B, Q1A–Q1E and emerging FDA / EMA ADC guidance.

Molecular Characterization

Impurity & Safety Profiling

Sterility & Container Integrity

Stability & Formulation

Test CategoryCapability
Intact mass analysisLC-MS, accuracy < 5 ppm
DAR determinationHIC, RP-LC, LC-MS (±0.2 precision)
Conjugation site mappingLC-MS/MS
Aggregation & puritySEC-HPLC, CE-SDS
Higher-order structureCD, FT-IR, DSC (Tm ±0.5 °C)
CategoryControl Capability
Free payloadLOQ ≤ 0.05%
Genotoxic impuritiesICH M7 compliant, LC-MS/MS
Residual solventsUSP<467>, GC-MS
Unconjugated antibodyHIC ≤ 1%
TestCapability
EndotoxinLOD ≤ 0.01 EU/mL
SterilityIsolator-based sterility testing
CCI testingVacuum decay, ≥ 1 μm sensitivity
Study TypeCapability
Forced degradationOxidation, heat, pH, light, freeze–thaw
Long-term stability2–8 °C, up to 24 months
FormulationLiquid and lyophilized
Transport simulationAgitation and vibration stress

Explore Our Antibody-Drug Conjugation Solutions

Creative Biogene offers dedicated development and manufacturing platforms tailored to different conjugate modalities and development stages.

Partner with Creative Biogene

With integrated chemistry, biologics, analytics, and regulatory infrastructure, Creative Biogene delivers development-ready conjugates with controlled quality, scalable processes, and regulatory confidence. Our ADC CDMO platform supports flexible collaboration models:

  • Fee-for-Service (FFS)
  • Full-Time Equivalent (FTE)
  • Integrated CMC development programs

Programs may enter at any development stage while maintaining continuity toward GMP manufacturing and regulatory submission. Contact our ADC CDMO team to discuss your program requirements and development strategy.

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