1. MCB preparation
In addition to developing and preparing the MCB of the recombinant E.coli carrying your plasmid of interest, we produce working cell banks (WCB) and store the MCB/WCBs.

2. Pilot manufacturing
Before actual manufacturing, we optimize culturing and purification conditions, and confirm plasmid yield on a small scale.

3. Final plasmid DNA production
Plasmid DNA is manufactured from the MCB in 25 L, 2 x 25 L, or 200 L single-use systems, or in a 2,000 L stainless-steel bioreactor in accordance with GMP processes, depending on the desired scale. Our facility is also able to perform automatic, aseptic filling, vialing, and labeling.

200 L single-use bioreactor

Aseptic filling

To ensure high-quality manufacturing, we perform quality testing during every step of the GMP-grade plasmid DNA production process.

Acceptance testing

• Plasmid DNA: confirm sequence match with the reference sequence
• E. coli used for transformation: phage denial testing

MCB quality testing*

• Colony morphology test (uniqueness test)
• Biochemical reaction test
• Plasmid retention test
• Restriction enzyme cleavage pattern test
• Phenotype test (UV sensitivity, antibiotic resistance, etc.)
• Production test (flask culture)
• Auxotrophy test
• Viable cell count test
• Number of plasmid copies
• Nucleotide sequence test of plasmid DNA
• Phage denial test

*These are examples of quality testing performed on the MCB. Specific details of MCB quality testing will be determined after consultation.

Post-manufacturing plasmid DNA quality testing

• Sterility testing
• DNA homogeneity (total ccc content)
• DNA concentration
• Endotoxin testing
• pH testing
• Host DNA residue testing

Cells at the limit of in vitro cell age (CAL) quality testing

We quality test E. coli cultures using the same testing that was used on the MCB to confirm that there is no change in the host E. coli during the production process.

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