ADC CDMO

ADC CDMO ServicesADC CDMO Services

From proof of concept to process lock, and on to global IND/BLA filing and commercial manufacturing - end-to-end ADC development and manufacturing services.

Site-specific conjugationRandom conjugationToxin-linker screeningDrug substance manufacturingDrug product manufacturingQuality control

Biologics CDMO ADC CDMO Media Services Analytical CRO

Capabilities

ADC service capabilityADC Capabilities

Full-chain capability covering ADC development and manufacturing, with parallel conventional and site-specific conjugation platforms.

ADC overview

Bioconjugate screening, from proof of concept to process lock, meeting IND/BLA filing requirements.

Process and testing method development

Conventional (random) plus site-specific conjugation platforms, with high-throughput conjugation reactions and multi-route purification.

Toxin-linker screening

Toxin and linker combination screening supporting candidate molecule optimization.

Drug product formulation and process development

ADC drug product formulation development and process scale-up.

Method development and structural characterization

Development of methods for conjugation site, DAR and structural characterization.

Drug substance manufacturing

ADC drug substance manufacturing from preclinical to commercial, with 4M1E total quality management.

Drug product manufacturing

Filling and lyophilization of 5 vial formats, with three-dimensional risk / process / environmental control.

Quality control

A GMP-compliant manufacturing and testing release system.

Manufacturing

Drug substance and drug product manufacturingDS & DP Manufacturing

2 independent production lines

Drug substance (DS) manufacturing

Preclinical to commercial scale
Process transfer and scale-up
4M1E total quality management framework

Lyophilization 5 m2 / 20 m2

Drug product (DP) manufacturing

Filling of 5 vial formats
Dual liquid and lyophilization modes
Built to GMP standards, supporting registration and commercial supply