Plasmid Safety Test

Safety testing is part of our plasmid manufacturing and development service and is a critical quality control component prior to product release. Creative Biogene's highly trained scientists and project management team perform rigorous, one-stop biosafety testing during the GMP plasmid manufacturing process to ensure that the final product is released in compliance with regulatory requirements and is safe and effective for the next step production and application. This service can also be provided separately to clients who require it.

Plasmid Safety Test

Plasmid Safety Testing Services at Creative Biogene

Since plasmid is produced by microbial production system, contaminants may be introduced during GMP production and need to be thoroughly tested for safety at the time of final release. Creative Biogene offers high-quality plasmid safety testing services including:

Mycoplasma testing

This test is designed to ensure that the final plasmid product is free of mycoplasma contamination, which can have adverse effects on human or animal health.

Endotoxin testing

This test measures the level of endotoxin produced by bacteria during DNA production, which can cause severe immune responses in humans.

Bioburden test

This test is designed to ensure that the plasmid is free from bacterial, fungal and viral contamination. It is usually performed under controlled conditions using aerobic and anaerobic cultures, with the criterion that no growth of other bacteria is detected.

Toxicity test

This test is designed to ensure that the plasmid has no toxic effects on cells in vitro and no toxic effects on animals in vivo.

Methods and Standards of Security Testing

Creative Biogene enforces strict quality and safety standards in the production of GMP plasmids. We offer a range of advanced testing technologies to ensure that the plasmid products delivered to our customers meet regulatory safety requirements.

Testing Content	Testing Method	Standards
Mycoplasma contamination	Quantitative PCR	Negative
Endotoxin	Kinetic chromogenic LAL	< 10 EU/mg
Bioburden	Testing for total aerobes, anaerobes, spore formers and fungi	Not detected
Toxicity	In vitrocytotoxicity testing In vivo animal toxicity testing	Not detected

Why Choose Creative Biogene for Plasmid Safety Testing?

A dedicated quality and safety testing team provides expertise to ensure sound scientific methodology and GMP compliance.
Highly trained scientists can complete testing quickly to ensure on-time delivery in a GMP environment.
Raw data results and well-documented results analysis reports are provided as deliverables.

Creative Biogene offers a full range of GMP plasmid safety testing options to ensure that its production meets regulatory requirements and does not cause harmful effects in humans and animals. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.

Quick Inquiry