WuXi Biologics
Offering End-to-End Solutions
cGMP Manufacturing
As a leading Contract Development and Manufacturing Organization (CDMO), we support cGMP manufacturing of both bulk and final vaccine product to effectively meet your preclinical, clinical and commercial supply needs in a cost-effective manner.
The large-scale microbial-based facility utilized for vaccine lyophilization is designed and constructed based on U.S., EU and China cGMP standards. The site utilizes the same comprehensive quality systems implemented by all of our global GMP facilities. Site details include:
- BSL-1 facility with 2,000 m2 GMP manufacturing space, with multiple single-use bioreactors scaling up to 300 L and stainless steel lines scaling up to 2,000L.
- BSL-2 facility with up to 200L Stainless Steel Fermenter
- Flexible downstream lines with single-use technologies
- Temperature control processing capability
- One bulk product fill line
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 1,450 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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