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.
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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
Our Products and Services Support the Following Areas
Development
• Plasmid DNA Production and mRNA Synthesis & Purification
• mRNA Contract Development and Manufacturing Services
• Lipid Nanoparticle Formulation (LNP)
• Preclinical Assessment
• mRNA Development Services
Manufacturing & Formulation
• mRNA Contract Development and Manufacturing Services
• Lipid Nanoparticle Formulation (LNP)
• Cell Banking and Storage
• Facility Engineering Services
• mRNA Testing Services
Analytical & Quality Control
• Microbial Quality Control
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