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We offer analytical method development and cGMP quality control testing services to ensure the robust qualification of your cell and gene therapy product and compliance with global standards.
With state-of-the-art analytical instruments and more than two decades of experience in testing ATMPs, Cojourney takes pride in its committed team of over 30 analytical scientists. They work in close collaboration with both process development and manufacturing units to enable product and process understanding through analytics.
Regulatory Navigation: With our deep understanding of the unique regulatory challenges of ATMPs, we guide clients through complex analytical requirements, ensuring compliance and confidence.
Timely Product Delivery: Through rapid testing methods and streamlined processes, we expedite product release to meet critical timelines.
Optimized Sampling Strategies: We prioritize quality over quantity, minimizing sample volume impact while ensuring product quality, even at small scales.
With multiple platforms powered by state-of-the-art technologies, you can be confident in an accurate, holistic assessment of product quality.
For cutting-edge cell and gene therapy products, specialized quality control assays are often necessary to measure unique features not captured by standard tests. Our analytical team is adept at:
Get in touch to explore how we can collaborate to create tailored analytical solutions for your project.
CoJourney’s analytical method development and QC testing services are specifically designed to provide confidence in product quality throughout the manufacturing process. Testing procedures have been developed following a quality system that meets FDA, EU, and NMPA regulatory guidelines. With over 20 years of experience in the GMP manufacturing of cell and gene therapies, we possess the expertise to develop novel assays to support your specific requirements.
Please download our brochure for more information about our plasmid, viral vector, and testing services.
