Sterility Testing of mRNA Vaccine

Sterility testing

As a new frontier in vaccinology, mRNA vaccines are changing the way we treat many major diseases, such as cancer, infectious disease and inherited disorders. For the development of vaccines, including mRNA vaccines, sterility testing should be conducted throughout the whole production process. To match the rising need for quality mRNA vaccine development, Creative Biogene provides efficient and reliable sterility testing services. As one of the leading service providers for mRNA-based drug R&D, we are committed to accelerating mRNA vaccine development and providing safe, adaptable, high potent, and low-cost vaccine candidates.


Typically, sterility testing contains direct inoculation of prefilled syringes (the conventional vehicle for dispensing vaccine) and membrane filtration. Prior to testing, the sample matrix should be qualified to examine any inhibitory effects. In addition, due to artificial visual analysis as well as subjective evaluation, the testing is laborious, possibly adding up to hours and potential days for each assay.

Our Platform

The fully-equipped laboratory

The ability to detect the presence of viable microorganisms is an important safeguard for vaccine production. With the fully-equipped laboratory and a team of excellent experts, we have developed a platform under the GMP regulations and global regulatory requirements to satisfy our customers’ sterility testing needs. To ensure the results with no false-positive, we provide isolation technology for sterility testing based on advanced instruments, such as the airlock technology and HEPA filters. Our sterility testing can be quickly done using our automated detection instrument and optimized testing consumables.

Advantage of our services

  • Reliable and repeatable results. Thanks to the stringent procedures and advanced instruments.
  • Efficient and scalable testing. Based on the automated detection instrument and optimized testing consumables.
  • Fast delivery report. The historical trend reports with respect to environmental monitoring data and false positive rates are available upon request.
  • One-stop solution.

Creative Biogene is passionate about strong customer orientation and high-quality service. We understand that compliance and efficiency are critical in sterility testing processes. With the help of Creative Biogene, our clients can obtain the advantages of eliminating bottlenecks, decreasing testing time as well as accelerating vaccine production. In addition, our clients have direct access to our staff to keep track of the progress of their projects. If you would like more information about our sterility testing capabilities, please contact us or directly send us an inquiry.

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