GMP Plasmid DNA

Working in close contact with clients, Waisman focuses to design a tailored fermentation and purification process for manufacture of your GMP plasmid DNA molecule. Our platform plasmid manufacturing process yields up to multi-gram quantities of clinical grade plasmid DNA that can be used for direct injection as DNA vaccines, gene therapy, or ex-vivo applications such as cell and gene therapies. Waisman has delivered plasmid DNA vaccines for Phase 1/2 clinical trials and can support Phase 3/commercial for plasmid DNA used as an ancillary material. Download our Plasmid Flyer to learn about all our services.

We recognize that both time and budget are client concerns and these are prioritized in project management. Therefore we have established a streamlined workflow with cell banking, pilot scale engineering, and full scale cGMP production to efficiently deliver for clinical trials. In addition, Waisman has licensed fermentation technology from Nature Technology Corporation that has been used to increase expression of some plasmids up to 2.5 grams/liter.  (Facility/Microbial Suites).

Plasmid Production Specifics

  • cGMP production of multi-gram batches for direct injection and ex-vivo (e.g. modified T-cells) applications
  • 30L fermentor capacity with options for up to 120L per production lot
  • Scalable manufacturing process free of organic solvents and animal derived products
  • Superior Quality Control testing including HPLC and qPCR
  • In-house development of custom potency assays
  • Master/Working Cell bank production and testing
  • Access to plasmid backbones and fermentation methods to enhance process yield for challenging plasmids
  • Validated aseptic filling of final product for up to 2,000 doses

Ultra-Pure Plasmid DNA

Waisman has recently developed an Ultra-Pure Plasmid DNA purification process for clinical applications such as infectious disease vaccines with very tight specifications on host contaminants. This Ultra-Pure process step can further improve plasmid DNA quality and purity beyond standard manufacturing processes. See below table for specification differences from our standard process.

GMP Plasmid Highlights

  • High yield fermentation
  • No animal derived enzymes or organic solvents
  • Scalable production process
  • Milligram to multi-gram capacity
  • DNA vaccines, ex vivo gene therapy, or bioprocess manufacturing applications

Standard QC Release Test

Description

Standard Starting Specification

Ultra-Pure StartingSpecification

Typical Plasmid Quality Control Specifications

A260/A280

Absorbance ratio

1.8-2.0

1.8-2.0

Plasmid Form (% supercoiled)

HPLC

> 85% supercoiled

> 90% supercoiled

Host Protein

Host Cell Protein ELISA

< 1.0%

< 1.0%

Residual E. coli DNA

PCR for host gDNA

< 1.0%

<< 0.1%

Residual E. coli RNA

Gel or HPLC for host RNA

< 1.0% by HPLC; undetectable (gel)

< 0.1% by HPLC; undetectable (gel)

Endotoxin

Limulus Amebocyte Lysate (LAL) assay

< 10 EU/mg

< 10 EU/mg

Sterility

USP <71> Sterility Test

Pass

Pass