Analytical Services and Quality
Ensuring a safe and well-characterized product, right from the start.
// End-to-end
Capabilities
Analyzing Products from End to End
From concept through development, our team characterizes products and process through robust analytical methods. The result is a well-defined product that meets regulatory requirements and is suitable for your clinical development and commercialization needs.
Accelerating Programs with Quality
Our quality control methods and analytics help accelerate your timelines, saving costs.
Nate Cyr
Senior Manager, Laboratory & Site Services
Analytical Services and Quality
Assay DevelopmentCell and gene therapy assays are complex and custom development approaches are needed based on unique product profiles and mechanism of actions of each product. Our team of experts develops spectrum of product specific assays including cell-based potency assays, supporting the process development and manufacturing efforts while ensuring developed products can be characterized and released for its intended clinical and commercial usage. |  |
Quality Assurance and ValidationOur Quality assurance team provides oversight to our entire cGMP operation and ensures cGMP compliance are maintained through our established quality systems. Our systems, analytics and QC labs with state-of-the-art automation enable us to assure proper quality and prepare your products, faster. |  |
Platform AssaysAlong with our established cell therapy and viral vector platform processes, we have established panel of standard assays that are ready to be employed to measure product safety, potency, purity, stability, and identity. |  |
Product QC Release TestingBaseCamp® offers more than 40 state-of-the-art quality control release methods in-house to support in process control and cGMP product release. Together, we can accelerate the release of your programs for clinical development and commercialization. |  |
StabilityBaseCamp offers stability study programs for your products in accordance with ICH guidelines. We will develop customized stability study protocols with you based on your program needs and perform studies at various storage temperature and timepoints. |  |
Our Technology Platforms
We gain insights across gene editing, iPSCs, and RNA, cell, protein, and vector technologies to create a virtuous cycle that enable us to iterate and apply best practices across our ecosystem to accelerate and improve the product development process.
Our Therapeutic Approaches
Our expansive network of technologies and capabilities enables us to discover, develop, manufacture, and commercialize a broad spectrum of cell and gene therapies.
Elevated Insights
Partner with ElevateBio®
Wherever you are in your cell and gene therapy product lifecycle, we can strengthen and accelerate the development of your transformative therapies with our enabling technologies unmatched manufacturing capabilities.
// Work with us
