End-to-End Bioconjugation
Development & Manufacturing
Samsung Biologics provides end-to-end bioconjugation development and
manufacturing services for bioconjugated therapeutics. Built on biologics
manufacturing expertise, its integrated services coordinate process
development, analytical characterization, formulation, and manufacturing
execution within a connected operational environment. These capabilities
help reduce bioconjugation complexity, maintain process consistency, and
enable reliable scale-up across bioconjugation programs, including ADC programs.
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*ADC: Antibody-Drug Conjugates
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Bioconjugation Infrastructure
Our bioconjugation infrastructure in Songdo Campus supports a broad range of conjugation modalities, with a dedicated ADC Facility exclusively built for high potency API (HPAPI) handling operated separately from our other biomanufacturing services to ensure the highest standards of safety and regulatory compliance.
The Songdo Campus features:- Expedited and flexible drug substance (DS) delivery
- Expertise in quality and a proven operational track record
- Integrated systems with established tools and procedures
- Stable supply chain management system
Dedicated ADC Facility
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Single-use and stainless-steel reactor systems support
bioconjugation processes at scales up to 500 L train, enabling
seamless progression and scale-up from development through
manufacturing.
Integrated laboratories support bioconjugation development,
quality control (QC), and MSAT activities across manufacturing
operations.
Designed for high potency API (HPAPI) handling, the facility
incorporates stringent containment systems engineered to
achieve Occupational Exposure Limits (OELs) below 1 ng/m.
Coordinated Bioconjugation Execution Across Development and Manufacturing
Development, analytical characterization, formulation, and manufacturing activities are coordinated to enable reliable progression
from early development through commercial-scale manufacturing.
Manufactruing-ready Bioconjugation Development
Development strategies are designed to improve process reproducibility, maintain controlled DAR profiles, and prepare programs for reliable manufacturing scale-up.
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Conjugation
Method, parameter optimization, DAR variation control
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Analysis
Analytical Method development, Precise Analysis and Characterization
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Formulation
Stability enhancement and Lyo development
Scalable Manufacturing Execution Across Bioconjugation Operations
Manufacturing operations span antibody preparation, conjugation, purification, formulation, and bulk drug substance manufacturing, to support reliable scale up across bioconjugation programs.
Payload & mAb Prep
- mAb Thawing
- Payload Prep
- UF/DF1
- Reduction
Conjugation
- Conjugation
- Quenching
- UF/DF2
- Chromatography
Formulated Bulk
- UF/DF3
- Formulation & Bulk Fill
Drug Product
- Fill/Finish
Analytical Characterization for Process and Product Understanding
Analytical characterization capabilities support DAR analysis, comparability assessments, and manufacturing consistency across
bioconjugate development and manufacturing activities.
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Raw Material
- ID for payload-linker
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IPC Testing
- Protein concentration
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Chemistry
- DAR
- Residual solvent
- Free drug
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Biochemistry
- Bioassay
- Antigen binding assay
- Cytotoxidity assay
Bioconjugation Services
Summary
- Samsung Biologics supports end-to-end bioconjugation development and manufacturing for ADC programs.
- Core capabilities include conjugation process development, analytical characterization, formulation, and drug substance manufacturing.
- Manufacturing operations span payload and antibody preparation, conjugation, purification, formulation, bulk fill, and fill-finish.
- Analytical characterization supports DAR analysis, comparability assessment, IPC testing, and manufacturing consistency.
and manufacturing capabilities through strategic investments
supported by the Samsung Life Science Fund.
development technology
technology for ADCs
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