Samsung BioLogics

Seed bioreactor process development and production scale-up services for clinical biologics manufacturing.

Customized CMC development solutions providing tailored packages including Simplified IND, Comprehensive IND, and Enhanced CMC.

Pre-clinical manufacturing services utilizing single-use bioreactors and AKTA equipment to support process evaluation and toxicology studies.

Pre-clinical aseptic vial filling services and flip-cap crimping to secure a reliable supply for preliminary studies.

Comprehensive cGMP biologics manufacturing services from clinical to commercial scale, covering drug substance manufacturing, drug product, and aseptic fill-finish.

End-to-end biologics CDO services providing development solutions from drug discovery and lead optimization to IND filing.

Global CDMO delivering high-quality end-to-end biologics with precision and at scale, offering seamless development and manufacturing services from late discovery to final aseptic fill-finish.

A rapid and agile assessment tool that scores drug candidates based on developability criteria to save time and cost in the late discovery or early development stage.

Comprehensive contract development services including cell line development, process and analytical development, formulation development, non-GMP and cGMP manufacturing, and IND filing support.

Cell line development services to support accelerated timelines from gene to IND filing.

Advanced drug substance manufacturing services with a proven track record, high batch success rates, and scalable biologics CDMO operations ranging from 1,000 L to 15,000 L bioreactor capacity.

Integrated aseptic fill-finish services for biologics and small molecules to support reliable drug product delivery.

Plant 3 is located in Bio Campus I and has a total production capacity of 180000 liters.

Samsung Biologics' U.S.-based biologics manufacturing site in Maryland providing 60 kL drug substance capacity for clinical and commercial-scale production.

Leaflet detailing aseptic fill-finish and drug product manufacturing capabilities.

Samsung Biologics standardized biomanufacturing framework applied consistently across facilities to ensure plant-to-plant equivalency, speed, and reliable biomanufacturing execution.

A biomanufacturing facility located in Bio Campus 2 with a scheduled completion in 2032 and a production capacity of 180,000 liters.

Comprehensive in-house analytical capabilities for biologics, supporting a broad spectrum of programs from monoclonal antibodies to advanced non-mAb modalities with customized method development strategies.

Plant 1 is located in Bio Campus I and has a total production capacity of 30000 liters.

End-to-end ADC development and manufacturing services including late discovery, conjugation, analysis, formulation, and payload/mAb prep.

Non-GMP and CGMP drug substance and drug product manufacturing for clinical trials and regulatory filing.

Process development and manufacturing services for pDNA, IVT, and LNP supporting mRNA drug substance and drug products.

An asymmetric BsAb platform allowing high yield and manufacturability by maximizing heavy chain-light chain (HC-LC) pairing.

Informational brochure detailing Antibody-Drug Conjugate (ADC) contract development and manufacturing services.

Bioprocess development services designed to de-risk early-phase development while minimizing time and cost.

A high-performing CHO-K1-based cell line development platform designed for optimal yield and productivity.

Upgraded S-CHOice cell line engineered to produce enhanced ADCC activity antibodies.

Comprehensive GxP-compliant analytical testing services covering the entire biopharmaceutical manufacturing process from raw materials to final drug product release.

Late discovery services supporting faster IND filing as part of end-to-end biopharma development.

A glycan profile modulation platform providing in-depth investigation into critical quality attributes (CQAs) and cell culture conditions.

A patient-derived organoid platform that supports precision drug screening, drug discovery, and translational research using tumor organoid models, AI-based predictive analysis, and multi-omics data.

A transient expression platform using S-CHOice with high-yield productivity and quality for rapid material provision.

An Electronic Quality Management System (eQMS) that supports change control, documentation management, and event tracking across all CDMO services.

Stable liquid formulation platform for high concentration subcutaneous injection supporting complex modalities and delivery routes.

An intensified cell culture platform that improves productivity by increasing the initial cell density of a main culture through N-1 perfusion.

A precise charge variant modulation platform achieved through a thorough screening process and optimization of media, additives, and process parameters.

A Laboratory Information Management System supporting round-the-clock data integrity and testing workflows in quality control testing.

Automated high-throughput cell imaging and in-channel assay platform for rapid selection of top-producing clones.

A Learning Management System platform that ensures consistent GMP training, qualification tracking, and certification for all personnel.

Gentle, imaging-based system for single-cell sorting into multi-well formats.