Small-Scale cGMP Plasmid DNA

Advance early-phase trials and pipelines with Small-Scale cGMP services

Our right-sized process ensures a seamless experience, allowing you to focus on what matters most - advancing your early clinical programs with reliable, consistent material in preparation for pivotal trials.

Are you a developer needing ≤500mg of cGMP plasmid DNA for one of the following applications?

A small patient cohort clinical trial
Small-batch AAV manufacturing for therapeutic delivery in small target tissues
Small-batch lentivirus manufacturing
CRISPR-based gene editing
Transposon therapy

Full cGMP oversight at quantities ≤500mg

Upstream Growth

The growth strategy will employ a single use 30L fermenter scaled down to a 10L working capacity. An Aldevron-generated Master cell bank will serve as the starting material for the upstream growth process.

Downstream Purification

Downstream processing operations include;

capture via membrane-based anion exchange chromatography
directly into polishing via Thiophilic adsorption chromatography
followed by final buffer exchange via TFF.

Dispensing

Terminal 0.2- micron sterile filtration is completed immediately before product fill. The purified plasmid material is then dispensed in vials at a standard 1mg/mL concentration in a cleanroom environment.

Quality Control

Aldevron offers a robust panel of Quality Control assays prior to release of the plasmid. This is to ensure that the purified plasmid DNA meets the requirements that have been pre-determined by the client for their specific end application.

Product Release

Once all quality control tests have been completed, Quality Assurance will release and will issue a CoA.

MBR (Master Batch Record)
CoA (Certificate of Analysis)
TSE/BSE Statement

Aldevron offers guaranteed deliverables with each project, and our Small-Scale cGMP plasmid DNA service offering can transition to our traditional cGMP manufacturing with fermenters up to 300L.

Frequently Asked Questions

Is there a minimum deliverable?

While there is no minimum requirement for our Small-Scale cGMP plasmid service, it is tailored and optimized for quantities up to 500mg.

How does the small-scale manufacturing process differ from your traditional cGMP manufacturing?

The small-scale manufacturing process involves using a 30L single-use fermenter, which is downscaled to a 10L working capacity. However, it’s important to note that despite the scale reduction, we maintain a full cGMP process. This ensures that our clients continue to receive the exceptional quality they expect from Aldevron’s typical service agreements.

Are the specs the same as those of our traditional cGMP plasmid manufacturing?

Yes. We provide clients with the flexibility to choose their preferred final buffer, but it’s important to be aware that we can only accommodate a final concentration of up to 1mg/mL.

Do I need an engineering run for manufacturing?

This platformed process will not require an engineering run. However, engineering runs are available upon client request.

Is this process scalable when my clinical trial progresses to a pivotal trial?

Yes! This process was developed to serve customers who need small quantities of cGMP plasmid DNA and intend to transition to larger phases and scales of material. We use the same QC specs seen in larger-scale cGMP manufacturing runs.

Does Small Scale cGMP require master cell banking?

Yes, master cell banking is an essential requirement for all cGMP plasmid DNA manufacturing processes.

Contact a plasmid DNA specialist today!

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