Quality System
Our global quality systems ensures holistic data integrity management, quality oversight of tech transfer, CMC support for IND and commercial applications, and GMP compliance throughout production.
Service
Plasmid Design & Manufacturing
WuXi Advanced Therapies offers GMP-like and GMP production of plasmids for use in a wide variety of R&D, clinical, and commercial bioprocessing applications.
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Experience With Complex Custom Plasmids
Our patented plasmid technologies and experience allow us to successfully design and manufacture custom plasmids used in research, clinical, and commercial processes.
Consistent and Secure Supply
We apply robust engineering, manufacturing, and analytical quality control processes with oversight provided by a highly trained quality assurance team.
4 FDA DMF
Including Lentivirus Packaging, Plasmids 2.0, AAV Helper Plasmid and Plasmid Analytical Procedure.
High Quality
As evidenced by testing results that demonstrate high-purity and homogeneity with low endotoxin levels.
Ability to Scale
Providing up to 200L at a rate of 60 batches annually to deliver GMP plasmids in as fast as 3 months.
Why Us?
WuXi Advanced Therapies provides a single source for your most complex plasmid design and GMP manufacturing challenges.
Quality System
Our global quality systems ensures holistic data integrity management, quality oversight of tech transfer, CMC support for IND and commercial applications, and GMP compliance throughout production.
Automation
Our production processes utilize single-use consumables and fully closed and automated processes.
Antibiotic and Animal-Free
Our antibiotic-free manufacturing process eliminates the need for residual antibiotic testing and our entire process leverages single-use and animal-component free materials to minimize microbial contamination.
Proven Process
- Client MCB
- Process development (5L-200L bioreactor)
- Vial thawing and seed preparation
- Fermentation (200L bioreactor)
- Cell Lysis (Alkaline)
- Purification (Chromatography)
- Fill & finish (Aseptic process)
- QC Testing
- QA Release
Streamlined Project Management
Your plasmid(s) will be produced and tested under a single work order, saving you time and effort in contracting. You will also be assigned a single project manager who will coordinate all activities related to both manufacturing and testing, saving you time and reducing risks related to communication issues.
Integrated Platform for Plasmids
WuXi Advanced Therapies offers a complete suite of services for intricate plasmid design and manufacturing. Our seasoned teams deliver high-quality plasmids for research, clinical, and commercial applications with robust analytical testing.
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One Stop Source for Plasmid Design & Manufacturing
Our expertise and patented plasmid designs allow expedited turnaround on your research and GMP-grade plasmid projects.
Viral Type
- AAV
- LVV
- Protein Expression
Grade
- Research
- Clinical GMP
- Commercial GMP
Scale and Yield
- Up to 200L batch size
- 60 batches annually
- Yields up to 80 grams
Service Features
- Patented plasmid expression services
- Antibiotic and animal-free production
- Aseptic fill and finish
- Integrated testing
- Bacterial cell banking
- Phase appropriate quality management system