As a trusted ADC CDMO partner, Samsung Biologics is proud to expand
its range of services to include bioconjugation and the end-to-end
development and manufacturing of antibody-drug conjugates (ADCs).
Our standalone ADC bioconjugation facility is supported by the same robust GMP
systems that power our high-capacity clinical and commercial biological manufacturing,
ensuring the highest standards of quality, compliance, and efficiency.
Dedicated ADC Facility for Streamlined Drug Substance Manufacturing
- Our purpose-built ADC manufacturing site enables unified coordination from conjugation development to final formulation. This site features:
-
- Expedited drug substance (DS) delivery with flexibility at a single site
- Expertise in quality and proven operational track record
- Integrated systems with established tools and procedures
- Stable supply chain management system
Key Features of Our ADC Facility
-
Our ADC facility is equipped with single-use and stainless steel
reactors supporting up to a 500 L conjugation train, enabling
scalable and flexible ADC manufacturing. It includes full-scope
laboratories for ADC development, quality control (QC), and MSAT.
The facility is built to handle high-potency APIs (HPAPIs) with
stringent high-containment systems, achieving an Occupational
Exposure Limit (OEL) target of 5 ng/m³ to ensure safety and
compliance at every step.
Dependable ADC Services From a Trusted CDMO
We deliver end-to-end ADC services, from antibody production and conjugation development to full-scale ADC manufacturing.
As a leading ADC CDMO, Samsung Biologics ensures every stage of the antibody-drug conjugate lifecycle is supported with expert execution and regulatory precision.
Agile ADC Development Services
Our agile approach to ADC development is designed for speed, flexibility, and precision. With dedicated teams and streamlined workflows, we accelerate timelines from cell line development to ADC formulation, delivering robust solutions in as little as 12 months.
-
Late discovery
Tool box options for the best development choice
-
Conjugation
Method, parameter optimization, DAR variation control
-
Analysis
ADC Method development, Precise Analysis and Characterization
-
Formulation
Stability enhancement and Lyo development
Concurrent development of mAb and ADC
- Cell Line Development
- mAb Process Development
- ADC Process Development
- Conjugation parameter development
- Downstream process development
- ADC Formulation development
- Analytical method development
- Non GMP mAb Tox, Non GMP ADC DS
- GMP mAb DS, GMP ADC DS
- 12 months
Flexible ADC Manufacturing Processes
Samsung Biologics’ cutting-edge ADC facility is engineered to handle every phase of ADC manufacturing. Our expert team creates tailored timelines that address all ADC components, ensuring flexibility throughout the process. From mAb thawing to formulation and bulk fill-finish, we customize the development journey for each client.
Payload & mAb Prep
- mAb Thawing
- Payload Prep
- UF/DF1
- Reduction
Conjugation
- Conjugation
- Quenching
- UF/DF2
- Chroma- tography
Formulated Bulk
- UF/DF3
- Formulation & Bulk Fill
Integrated ADC Analytical Testing
At Samsung Biologics, all essential analytical tests for ADC development are conducted at a single site, working closely with both the ADC development and manufacturing teams. This integrated approach simplifies the process and guarantees stringent quality control at every stage.
-
Raw Material
- ID for payload/linker
-
IPC Testing
- Protein concentration
-
Chemistry
- DAR
- Residual solvent
- Free drug
-
Biochemistry
- Bioassay
- Antigen binding assay
- Cytotoxidity assay
We are committed to staying at the forefront of advanced ADC technology by making active investments
through the Samsung Life Science Fund.
through the Samsung Life Science Fund.
AIMEDBIO
Cutting-edge ADC
development technology
development technology
brickbio
Protein engineering
technology for ADC
technology for ADC