Virus Packaging Plasmids

VectorBuilder offers GMP-like and GMP-grade lentivirus and AAV packaging plasmids for the manufacturing of pre-clinical and clinical viral vectors for gene and cell therapies. Produced in our state-of-the-art facilities, each plasmid has been optimized to produce high titers of virus and has undergone thorough quality control.

Plasmids offered

We offer the following GMP-like and GMP-grade plasmids:

Highlights

• Optimized and validated for high virus yield
• Off-the-shelf plasmids available for immediate use
• Plasmids produced under animal-free and antibiotic-free conditions
• Royalty free
• DMFs available simplifying FDA IND application
• Kan resistance

Grades of Packaging Plasmid Offered

• GMP-like plasmid

  GMP-like plasmid DNA is intended for pre-clinical studies such as animal testing of drug safety and metabolism. It is produced in a manner that adopts key features of GMP guidelines, including comparable production process and similar quality attributes. Production is performed in segregated production suites with document control and traceability. GMP-like grade can thus be viewed as a small-scale mimic of the final GMP product, but with much lower cost and faster timeline. A certificate of analysis (COA) and TSE/BSE statements are provided at product release.

• GMP-grade plasmid

  GMP-grade plasmid DNA is produced in our certified GMP suite with strict adherence to GMP guidelines. A comprehensive quality assurance system is implemented throughout the production process. A wide range of in-process and release QC assays are performed to ensure that the plasmid DNA meets or exceeds the desired quality and safety standards. A batch release report fully documenting the production process and a COA are provided at product release.

  Learn more about our GMP plasmid manufacturing

Quality Control and Release Criteria

The list below summarizes the main QC assays and specifications for the release of GMP-like and GMP-grade plasmid.

Documents

Brochures & Flyers

• GMP virus packaging plasmids
• GMP manufacturing for gene & cell therapy