Substandard and falsified vaccines put individuals at risk of contracting preventable diseases and erode public trust in vaccines and the healthcare system. Vaccine manufacturers, regulators and law enforcement need quality control tools that help keep these dangerous and sometimes deadly products off the market. USP recognizes this need and provides resources that support the high-quality manufacturing, packaging, and release processes of vaccines. These resources help to address broader challenges associated with vaccine distribution and administration, which further contribute to public confidence in vaccination efforts.
What's New
Products & Resources
Standards & Materials
- USP Documentary Standard: 〈198〉 Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides Used in Vaccine Manufacture
- Reference Standard: PS NMR System Suitability
- USP Documentary Standard: 〈1234〉 Vaccines for Human Use—Polysaccharide and Glycoconjugate Vaccines
- USP Documentary Standard: 〈1235〉 Vaccines for Human Use—General Considerations
- USP Documentary Standard: 〈1238〉 Vaccines for Human Use—Bacterial Vaccines
- USP Documentary Standard: 〈1239〉 Vaccines for Human Use—Viral Vaccines
- Cross-Reacting Material 197 (CRM197) Reference Standard
- Thyroglobulin for Molar Mass Determination Reference Standard – NEW!
- Squalene Based Oil in Water Nano-Emulsion for Quantitation Analytical Reference Material – NEW!
- Octoxynol-9 Solution for Residual Quantitation Analytical Reference Material – NEW!
- BSA for Molar Mass Determination Reference Standard
- DNA Phosphoramidite Reference Standards
- Genomic DNA Analytical Reference Materials
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Education
- Aligning mRNA Progress With Regulatory Streamlining - NEW!
- Application Note: Quality Standards for DNA phosphoramidite raw materials - NEW!
- Modern Approaches to mRNA Manufacturing (Webcast)
- mRNA Vaccines Series: Principles and Production (Webcast)
- mRNA Vaccines Series: CMC and Analytics (Webcast)
- mRNA Open Forum: Collaborating to Pave the Way for mRNA-based Vaccines and Therapeutics Quality
- An Introduction to USP’s COVID-19 Vaccine Quality Assessment Toolkits (On-Demand)
- COVID 19 Vaccine Distribution and Storage: Increasing Access to Quality, Safe, and Effective Vaccine Products (On-Demand)
- Introduction to GMP Manufacturing and Characterization of Vaccines for Human Use (On-Demand)
- Cell Banking for Manufacturing of Vaccines (On-Demand)
- Production of Vaccines and Sterile Biologics (On-Demand)
- Quality Control of Vaccines Manufacturing (On-Demand)
- Regulatory and WHO Prequalification Considerations for Vaccines (On-Demand)
- What’s New in Biologics Focus on USP’s Vaccine Initiatives (On-Demand)
- Bringing COVID-19 Vaccines and Therapeutics to the Global Community (On-Demand)
- Implementing Improved Analytical Methods to Support Vaccine Quality (On-Demand)
- What’s New in Biologics? Focus on USP’s COVID-19 Response (On-Demand)
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