Service Module
Pre-production quality control
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Cell bank release
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Test and release of raw materials and excipients
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Environmental monitoring, water monitoring, and process gas monitoring
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Analytical method transfer /verification
In-process quality control
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Environmental monitoring, water monitoring, and process gas monitoring
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Intermediates and intermediate solution control
Product quality control
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Sample management
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DS/DP release test
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Stability study
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Customer audit
Pre-production Quality Control
QC system supports GMP pre-production quality control, to ensure that the raw materials and excipients, analytical methods, production environment, water and process gas used throughout the production meet the requirements.
Production Quality Control
QC system supports GMP production monitoring, continuously monitoring the production environment, water system, process gases, and monitoring the progress of intermediate process, to ensure product quality.
Product Quality Control
The QC team supports production product release testing and sample stability studies, to ensure that product quality meets the specification. It also continuously monitors product stability and provides product auditing service.
Services
The main testing items that QC can support
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Biological activity assay
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Residual DNA testing
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Residual HCP testing
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Residual
Protein A
testing
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Protein content, peptide mapping, cIEF, icIEF, IEC, CZE, purity (SEC, CE-SDS, HIC, RP), glycofile, free drug, Assay, related substances, solubility, residual solvents, etc.
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TOC detection, infrared identification, optical rotation analysis,
pH value,
conductivity, Osmolarity, Sub-visible particles and visible particles, moisture, clarity test.
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Bacterial endotoxin test
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Microbial limit test (including control bacteria test)
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Sterility test
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Environment test
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Water system test
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Process gas test
Workshop
1500+ ㎡ independent GMP QC laboratory