Plasmid GMP Testing

Plasmids are critical for the production of traditional biologics and gene therapies, enabling the programming of cells to perform work that these cells were not originally designed to complete. There can be single plasmid stable transfections for biologics, while gene therapies may use up to three plasmids for a triple transient transfection process to produce viral vectors. Plasmids are commonly generated using microbial cell lines. Escherichia coli (E. coli) is the industry leader for plasmid production, however, there are other alternatives that can be used.

Whether a bio/pharmaceutical company is using one or more plasmids, E. coli, or alternative production systems, Eurofins BioPharma Product Testing can provide the full range of plasmid GMP release testing options to ensure purity and sequence accuracy.

Why Choose Eurofins BioPharma Product Testing?

• In addition to the final Certificate of Analysis, we also provide raw data results as a deliverable.
• Our industry leading online data portal, LabAccess.com, provides customers access to our LIMS system, allowing 24-hour access to data.
• Our dedicated Project Management team focuses on biosafety, rapid testing, and client communications to assure on-time delivery in a GMP environment.
• Our PhD scientists and Quality Assurance teams work together to provide expertise that ensures sound scientific approaches and GMP adherence.

Testing Considerations

When used for downstream production of biologics (i.e., monoclonal antibodies or mRNA) or viral vectors, plasmids are considered a raw or starting material. Since they are generated from microbial production systems, there is risk that a plasmid could introduce a contamination into the manufacture of the biopharmaceutical product. Microbial methods, including sterility and mycoplasma testing, are commonly performed to screen the plasmids prior to use for GMP biopharma product manufacturing.

The plasmid preparation should be free from residual host cell proteins and DNA. ELISA and PCR directed at the microbial host used to produce the plasmids can confirm this.

Sequence analysis is commonly included to confirm the identity of the plasmids and to assure against sequence variants and potential cross contamination.

The regulatory guidance addressing plasmid quality continues to evolve. Additional methods may be required by some agencies, such as concentration or copy number, homogeneity (confirmation) or restriction digest to address purity.

*Assay Number and Sample Requirements will change depending on compendial or PCR test methodology.

Click a link below to download one of our Plasmid GMP Testing resources.