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CDO Services
개요
Pilot scale에서 생산된 물질의 품질평가를 위해 분석법 개발을 진행하며,
해당 개발 과정은 CMO로의 기술 이전 시 Risk gap을 최소화 할 수 있는 최적화된 개발 방향으로 진행한다.
서비스 범위
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01높은 품질의 분석법 개발과 적격성 평가 서비스
High Quality Method Development & Qualification
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02종합적 특성분석 평가 서비스
Comprehensive characterization study
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03공정개발 시료에 대한 효율적인 분석 지원
Efficient analytic support for process development
팀 업무
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기준 및 시험법 수행 (Release Test)
- Quantity, Identity, Purity, Process-related impurity
- General test
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특성분석 수행 (Charaterization Study)
- Structural Characterization
- High-order Structural Characterization
- Glycan profile and Occupancy
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공정개발 시료 분석 (Analytical Support)
- Intermediate materials analysis
- High throughput analysis
Test Item
Method
Quantity Test
Titer (PA-HPLC/UPLC)
Protein Concentration (A280, SoloVPE)
ELISA
Protein Concentration (A280, SoloVPE)
ELISA
Identity & Purity Test
SE-HPLC/UPLC
IEX-HPLC
RP-HPLC/UPLC
HIC-HPLC
CE-SDS (R/NR)
icIEF or cIEF
IEX-HPLC
RP-HPLC/UPLC
HIC-HPLC
CE-SDS (R/NR)
icIEF or cIEF
Process-related substances & impurities
Residual Host Cell Protein
Residual Host Cell DNA
Residual Protein A
Residual Host Cell DNA
Residual Protein A
General method
pH
Osmolality
Osmolality
Structural Characterization
Intact Mass
Full Sequencing with terminal analysis
Disulfide bond
PTM
Full Sequencing with terminal analysis
Disulfide bond
PTM
Higher-order Structural Characterization
Circular Dichroism
Differential Scanning Calorimetry
Dynamic light scattering
UV Spectroscopy
MALS
FT-IR
Differential Scanning Calorimetry
Dynamic light scattering
UV Spectroscopy
MALS
FT-IR
Glycan Profile
N-Glycan Profile with identification of site
Sialic acid analysis
Sialic acid analysis