Analytical Services And Quality
Our robust analytical capabilities support development processes and ensure our products are well characterized, safe and meet regulatory guidelines.
Ensuring a safe and well-characterized product, right from the start.
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
Assay Development
Cell 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 Validation
Our 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 Assays
Along 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 Testing
BaseCamp® 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.
Stability
BaseCamp 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.
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.