WuXi Biologics
Offering End-to-End Solutions
cGMP Manufacturing
As a leading contract development and manufacturing organization (CDMO), we support the cGMP manufacturing of both bulk and final vaccine product to meet your preclinical, clinical, and commercial supply needs in a cost-effective manner.
The large-scale microbial-based facility used for vaccine is designed and constructed per U.S., EU, and China cGMP standards. The site leverages the same comprehensive quality systems implemented by all our global GMP facilities.
DS site details:
- BSL-1 facility with 2,000 m2 of GMP manufacturing space and stainless steel lines that scale up to 500 L
- BSL-2 facility with a stainless steel fermenter that scales up to 200 L
- Flexible downstream lines with single-use technology
- Temperature control processing
At the same location as the bulk vaccine is produced (for microbial-derived vaccines), WuXi Vaccines provides the full scope of final vaccine drug product manufacturing and fill services. Services include process development, tech transfer, facility fit, and robustness evaluation of final product manufacturing processes.
Highly flexible and automated final product GMP manufacturing
- RABS (Restricted Access Barrier System), oRABS and Isolator based filling lines
- Aseptic formulation for Alum adjuvanted vaccines
- Flexible container-closure systems including vials and prefilled syringes (1 mL to 3 mL long and normal).
- Single-use systems covering the entire equipment train with no shared product contact surfaces
- Capable for Liquid, Lyo, suspension, emulsion filling at variety scales from 800ml per batch to 20 millions doses per year
Fully-automated, robotic, gloveless, isolator-based Vanrx aseptic drug product fill system
In addition this site, fill of vaccines produced via microbial fermentation can also be performed at other manufacturing facilities globally, including lyophilized dosage forms.
Our dedicated team of highly-trained and experienced professionals allows us to offer:
- Analytical method transfer and qualification
- In-process control testing support
- GMP DS/DP release and stability studies
- Over 1,900 m2 of QC space comprising bioassay, physicochemistry, compendial testing, biochemistry, and microbiology laboratories as well as reference standard and stability storage rooms.
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