WuXi Biologics
Offering End-to-End Solutions
WuXi Biologics’ Platform Process
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Research Grade
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High Quality (HQ)
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cGMP
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WuXi Biologics platform production process
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√
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√
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√
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Certificate of Analysis (CoA)
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√
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√
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√
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E. coli master and working cell bank generation
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√
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√
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Controlled facility and environment
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√
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√
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Manufacturing summary report
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√
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√
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BSE/TSE statement
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√
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√
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QA oversight
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√ (critical steps only) |
√
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E. coli strain screening and process development
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√
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Product specific batch records
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√
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Validated facility/equipment/methods
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WuXi Biologics’ Platform Process
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Research Grade
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High Quality (HQ)
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cGMP
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Lead time for project kickoff (upon receipt of order) |
<2 weeks
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<4 weeks
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<4 weeks
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Manufacturing production period (starting from strain transformation) |
1-2 weeks
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16-20 weeks
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24-26 weeks
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Progress update
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Weekly
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Biweekly
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Biweekly
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Dedicated project manager |
Yes
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Yes
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Yes
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Certificated of Analysis (CoA) |
√
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√
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√
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Manufacturing summary report |
√
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√
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Manufacturing batch records |
√
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cGMP compliance statement |
√
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WuXi Biologics Platform
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Industry Benchmark | |
Upstream Fermentation Process
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Working volume. |
5 L and above
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5-500 L
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Harvest OD600 |
70-150
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55-120
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Plasmid titer |
1000 mg/L and above
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350-1000 mg/L
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Downstream Purification Process
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(Weak anion exchange + MMC) |
45-55%
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30-40%
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Key Product Quality Attributes
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sc pDNA ratio |
>96%
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>80%
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Endotoxin |
<2 EU/mg pDNA
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<40 EU/mg pDNA
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Host cell DNA-removed |
>99.5%
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>99%
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Host cell protein-removed |
>99%
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>99%
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RNA-removed |
>99%
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>99%
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