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Plasmid DNA

WuXi Biologics’ Platform Process
Research Grade
High Quality (HQ)
cGMP
WuXi Biologics platform production process
Certificate of Analysis (CoA)
E. coli master and working cell bank generation
 
Controlled facility and environment
 
Manufacturing summary report
 
BSE/TSE statement 
 
QA oversight
 

(critical steps only)

E. coli strain screening and process development
 
 
Product specific batch records 
 
 
Validated facility/equipment/methods
 
 

 


WuXi Biologics’ Platform Process
Research Grade
High Quality (HQ)
cGMP

Lead time for project kickoff 

(upon receipt of order)

<2 weeks
<4 weeks
<4 weeks

Manufacturing production period 

(starting from strain transformation)

1-2 weeks 
16-20 weeks
24-26 weeks
Progress update
Weekly
Biweekly
Biweekly
Dedicated project manager
Yes
Yes
Yes
Certificated of Analysis (CoA)
Manufacturing summary report  
Manufacturing batch records     
cGMP compliance statement    

 



  • 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

 

WuXi Biologics Platform
Industry Benchmark
Upstream  Fermentation Process
Working volume.
5 L and above
5-500 L
Harvest OD600
70-150
55-120
Plasmid titer
1000 mg/L and above
350-1000 mg/L
Downstream Purification Process
(Weak anion exchange + MMC)
45-55%
30-40%
Key Product Quality Attributes 
sc pDNA ratio
>96%
>80%
Endotoxin
<2 EU/mg pDNA
<40 EU/mg pDNA
Host cell DNA-removed 
>99.5%
>99%
Host cell protein-removed
>99%
>99%
RNA-removed
>99%
>99%