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
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
NMR spectroscopy in pharmaceutical analysis enables identification of substances and impurities, verification of chemical synthesis and compound characterization, supporting critical stages of pharmaceutical development.
Forced Degradation Studies
Element’s forced degradation, stress testing services per ICH Q1A guidelines assess the stability of drug substances or drug products with effects on purity, potency, and patient safety.
Pharmaceutical Stability Storage and Testing
Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.