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
Potency Assay DevelopmentCell and gene therapy potency 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 has the technical capabilities and in-house expertise for developing phase-appropriate potency strategies for cell and gene therapy drug products and critical components. We support a wide range of modalities and mechanisms of action, including genetically modified cell therapies, gene editing, and viral and non-viral vectors. Our phase appropriate approach to potency assay development includes pre-clinical to first in human, to supporting later stages of development towards commercial filing. |  |
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, identity, purity, stability, and potency. We have deep subject matter expertise and equipment to support a variety of analytical platforms including but not limited to, cell-based assays using flow cytometry readouts, immunoassays, protein-based assays, molecular biology techniques like PCR and NGS-based methods, biophysical methods, and microbiology. |  |
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. We offer seamless assay qualifications and transfers with aligned equipment and protocols between Analytical Development and Quality Control. Quality Control has separate labs for cell therapy and viral vector workstreams. 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. |  |
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. |  |
BaseCamp’s development of platform analytics supports a range of release testing for cell and gene therapy products using LentiPeakTM, our proprietary lentiviral vector (LVV) platform.
Analytical Development and Quality Control work collaboratively to offer a complete analytical control strategy for partners using our LentiPeak™ platform. Most assays are tested on site to reduce costs and improve turnaround times.
Our Technology Platforms
We gain insights across gene editing, cell therapy, and RNA, 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.
What’s New
Partner with ElevateBio®
Wherever you are in your product lifecycle, we can strengthen and accelerate the development of your transformative therapies with our enabling technologies unmatched manufacturing capabilities.
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