WuXi Biologics
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Plasmid DNA
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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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WuXi Biologics platform production process
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Certificate of Analysis (CoA)
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E. coli master and working cell bank generation
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Controlled facility and environment
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Manufacturing summary report
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BSE/TSE statement
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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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Product specific batch records
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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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| Manufacturing summary report |
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| Manufacturing batch records |
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| cGMP compliance statement |
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- Strain: Optimal for propagating retroviral/lentiviral genes
- Scale: 10-300L fermenter
- pDNA titer: 1300 mg/L and above (industry average 300-1000 mg/L)
- Yield: 45–55% (industry average 30-40%)
- Supercoiled (sc) pDNA ratio: > 96% (industry average >90%)
- High product quality and low impurities
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WuXi Biologics Platform
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Industry Benchmark | |
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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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