mRNA Analytical and Quality Control

As a leading provider of Pharma QC products and contract services, we deliver brilliant customer experiences through every phase of the testing, development, and manufacturing process - the entire lifecycle of drug therapies.

Analytical Quality Control

Successful testing and release of mRNA drugs is dependent on efficient analytical tools, validation guidelines and practices. We offer a complete line of analytical tools and reagents for your QC process including:

• HPLC Columns that meet USP Guidelines
• Analytical solvents produced with stringent controls specifically for your application
• Premium grade EMSURE^® inorganic compounds and solvents that possess the highest purity, most stringent quality controls, and regulatory documentation in combination with smart labels for improved tracking, handling, and safety
• Precision primary and secondary reference materials for impurity and sterility analysis
• Certified standards for Inorganic elemental impurity mixes in accordance to ICHQ3D guidelines
• Filtration products for dissolution testing
• Milli-Q^® pure and ultrapure water purification systems suitable for analytical testing

Microbiological Quality Control

From bioburden testing to mycoplasma detection, pyrogen, sterility testing, air monitoring, and surface testing, a variety of techniques are routinely employed to ensure drug safety and regulatory compliance. We can support your microbiological quality control program with:

• Complete membrane filtration systems, media and plates for bioburden testing
• Sterility testing consumables, media and instruments
• Complete solutions for monocyte activation test -based pyrogen testing
• Ready-to-use microbiological reference standards for every media quality control test
• Mycoplasma and viral testing options
• Application-specific air samplers
• Batch-tested, reliable media fill testing
• Reliable materials for production environment surface and personnel testing
• Milli-Q^® pure water systems adapted to suit your validation and application-specific requirements