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ElevateBio

ElevateBio

Powering the creation of cell & gene therapies at a speed the world deserves.

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Home/End-to-End Capabilities/Analytical Services and Quality

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.

The business model at ElevateBio is different because it combines so many different aspects. Being able to have science at a research level- ElevateBio has those capabilities. We’ve got cutting edge research going on, we have clients on the manufacturing side, on the process development side, and the analytical development side.

Nate Cyr

Senior Manager, Laboratory & Site Services

Analytical Services and Quality

Assay Development
Quality Assurance and Validation
Platform Assays
Product QC Release Testing
Stability
Assay Development

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

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

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

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

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.

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.

Learn about our technology

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.

Learn about our therapeutic designs

What’s New

All News & Pubs

// September 26, 2023

Kyverna Therapeutics and ElevateBio to Advance Kyverna’s Ingenui-T Cell Therapy Manufacturing

Read More about Kyverna Therapeutics and ElevateBio to Advance Kyverna’s Ingenui-T Cell Therapy Manufacturing

// May 24, 2023

ElevateBio Announces $401 Million Series D Financing to Further Accelerate Growth

Read More about ElevateBio Announces $401 Million Series D Financing to Further Accelerate Growth

Elevated Insights

Biotechnology: The Key to America’s Next Manufacturing Revolution

By Heidi Wagner, Global Head of Government Affairs, and Mike Paglia, Chief Operating Officer of ElevateBio BaseCamp

View Insight

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

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    • End-to-End Capabilities Overview
    • cGMP Manufacturing and Automation
    • Process Development
    • Analytical Services and Quality
    • Enabling Services
  • Technology Platforms
    • Technology Platforms Overview
    • Gene Editing
    • Induced Pluripotent Stem Cells (iPSCS)
    • RNA, Cell, Protein & Vector Engineering
  • Therapeutic Design & Approaches
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    • Ex Vivo Cell & Gene Therapies
    • In Vivo Gene Therapies
  • Partnering
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