As you develop your vaccines, having assurance that they are safe is a critical regulatory requirement and is crucial for distribution and widespread use.
Element provides vaccine analysis and safety testing, including nuclear magnetic resonance (NMR) testing, sterility, bioburden, endotoxin, mycoplasma testing, adventitious viruses screening, retrovirus, minute virus of mice, purity by SDS PAGE, pH and osmolarity. In addition, we have capabilities to expand, test and store your master and working cell banks.
The Element Advantage
Our FDA-registered and cGMP-compliant laboratories are ISO 17025:2017 accredited. Our scientists are experts, with the knowledge and capability to partner with you to provide quality results on your timeline, helping to ensure product quality and patient safety.
To learn more about Element’s vaccine analysis services, or to speak with one of our experts, contact us today.
- USP <198> NMR
- Adventitious viruses screening
- Minute Virus of Mice (MVM)
- Mycoplasma testing (PCR or direct/indirect method via USP <63>)
- Note: Viral vaccines that come from cell culture need to be tested for Mycoplasma
- Purity by SDS PAGE
- Large molecule CMC
- Routine bioanalytical support
- Master and working cell banks
- Cell bank safety testing
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