Optimization of key parameters

Provide targeted process optimization and validation of key parameters

Purification

Affinity chromatography

hydrophobic chromatography

Analytical services for mRNA

In-house Analytical Services supported by our quality control team

Comprehensive and stable release standards for plasmid/RNA/cell products, with more than 30  items confirmed and validated by our quality control team

Multiple core of the quality control team with extensive experience in IND application and analysis

Development and validation of LC-MS analysis methods for large nucleic acids (such as: capping rate and polyA)

Proficient in the development and validation of topological structure analysis methods for different plasmid sizes (3000bp-10000bp)

Culture of Quality                                                                                                           

Tricision is committed to achieving mRNA manufacturing quality metrics that meet or exceed customer and regulatory expectations. Our Quality Management System and team of quality experts ensure the highest level of consistency, purity, and comprehensive documentation.

Tricision’s commitment to quality includes:

1. cGMP compliance with FDA regulations, in addition to ICH and other applicable guidelines
2. Phase-appropriate Quality Management Systems
3. Annual ISO 9001 audits, frequent customer audits, and an established internal audit program
4. Comprehensive documentation and regulatory submission support

Facilities

Tricision’s facilities meet the demands of mRNA manufacturing for each phase of development. 

1. 1300m2 cGMP facility, opening in early 2020
2. Increased mRNA capacity (mg to g per batch)
3. On-site Quality Control and release testing
4. Buffer prep and hold area
5. Single-use consumables and process flows designed for cGMP manufacturing