Analytical Testing Capabilities
With extensive GxP experience and advanced analytical platforms, Samsung Biologics provides comprehensive testing services across the entire process — from raw materials to final drug product. All testing, including method transfer, validation, and qualification, is conducted in full compliance with ICH Q2(R1), FDA, EMA, PDMA and other relevant guidelines, ensuring reliable and consistent results that support on-time batch release.
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Raw material
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In-process control
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Release
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Stability study
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Validation
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Environmental
monitoring
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IPC & Release TestingOur QC team performs critical In-Process Control (IPC) and Drug Substance/Drug Product (DS/DP) Release Testing to ensure product quality and regulatory compliance throughout the manufacturing process.We offer a full range of
analytical services including: more- Compendial Testing
- Protein Concentration
- Titer
- N-glycan Profile
- Identification Test (Peptide Mapping / iCIEF)
- Flow Cytometry
- Bioassay
- Purity
- CE-SDS (Reduced / Non-reduced)
- Residual Host Cell DNA (qPCR)
- Residual Host Cell Protein (ELISA)
- Residual Protein A (ELISA)
- Potency (Binding ELISA)
- Sterility
- Endotoxin
- Bioburden
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Stability Study & TestingWe maintain controlled areas that have validated and monitored stability chambers suitable for the generation of GMP Drug Substance/Drug Product stability data. Physical and kinetic stability profiles are generated with real-time storage conditions, accelerated conditions, and stressed conditions (with temperature/humidity and/or light), in full compliance with ICH guidelines.Our stability testing includes: more
- Stability study under ICH conditions (real-time, accelerated, stressed)
- Potency (ELISA, Bioassay)
- Endotoxin
- Bioburden
- Sterility
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Environmental MonitoringThrough our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), we ensure that our controlled environments are maintained for the manufacturing of high-quality products.Our environmental monitoring
includes testing of: moreEnvironmental Monitoring includes testing for:- Viable/Non-viable air particles
- Surface Monitoring
Clean Utilities Monitoring includes testing of:- Water System
- Clean Steam
- Compressed Gases
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Biosafety TestingSamsung Biologics provides ‘End-to-End’ biosafety testing services for CMO / CDO clients. Our analytical services span development-phase testing to GMP lot release testing, including mycoplasma and virus detection assays.We also offer expanded
services such as: more- Mycoplasma Testing
- In Vitro Adventitious Virus Assay
- MVM DNA Detection
