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ElevateBio

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

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Home/End-to-End Capabilities/cGMP Manufacturing and Automation

cGMP Manufacturing and Automation

End-to-end solutions for cGMP manufacturing across the entire product lifecycle.

// End-to-end
   Capabilities

Manufacturing Your Vision

Our viral vector and cell therapy manufacturing platforms tap into the technology, regulatory and scale-up expertise required for genetic medicine development. Our BaseCamp® facility in Waltham, MA is built with multiple segregated manufacturing suites for cell therapy products and viral vectors, designed with flexibility to support development and commercial production needs.

Our Full Spectrum of cGMP Solutions

We provide the high-quality scaled manufacturing necessary for cell therapy and viral vectors, including lentiviral vectors and adeno-associated viral (AAV) vectors.

We’ve built these amazing capabilities at BaseCamp and have our sights set on bringing these capabilities to other regions of the country and the world. I think it’s important to help other companies that have these budding technologies to help patients.

Nate Cyr

Senior Manager, Laboratory & Site Services

cGMP Manufacturing and Automation

Clinical and Commercial Manufacturing
Technology Transfer
Process Validation
Supply Chain Management
CMC Compliance and Regulatory Affairs
Clinical and Commercial Manufacturing

Clinical and Commercial Manufacturing

Our manufacturing process is designed to accelerate and optimize the development of genetic medicines. With all the necessary manufacturing expertise and capacity under one roof, we can rapidly transition from preclinical processes to cGMP manufacturing for clinical development and commercialization.

Our purpose-built, multi-product BaseCamp facilities are designed to support autologous cell therapies, allogeneic cell therapies, iPSCs and viral vectors – we can meet you where you are in the process.

Technology Transfer

Technology Transfer

Our dedicated team can rapidly – and seamlessly – transfer your knowledge, processes, specifications, and data into cGMP manufacturing processes for clinical and commercial production. Our systematic technology transfer process enables us to safeguard your program timelines and quickly implement cGMP production based on your custom processes or our platform technologies.

Your success is our success, and our team is ready to work with you to identify process optimization opportunities and incorporate process improvement during product development lifecycle.

Process Validation

Process Validation

With our team of experts and their deep experience in cell and gene therapy commercialization, we can help you achieve the consistent production required for cell and gene therapies.

As products move through development towards commercial launch, we continually provide commercial readiness support through process validation activities and a robust system of analytics and release testing, so your product achieves the necessary quality and quantity, reliably.

Supply Chain Management

Supply Chain Management

Cell and gene therapy manufacturing processes are complex and supply chain management is even more so – which is why we provide our robust and streamlined supply chain management service.

Our validated Chain of Identity and Chain of Custody processes provide ‘needle to needle’ support for donor/patient materials and maintains traceability through apheresis, sample receipt, storage, manufacturing, and delivery of products from start to finish. We partner with you to streamline efforts and ensure we manufacture your product as quickly and efficiently as possible.

CMC Compliance and Regulatory Affairs

CMC Compliance and Regulatory Affairs

BaseCamp provides the necessary Chemistry, Manufacturing and Controls (CMC) functions, all under one roof. Our regulatory experts have deep understanding of the cell and gene therapy regulatory pathways and are involved in every stage of your product development lifecycle to provide regulatory support based on your program needs.

Our Technology Platforms

Our next-generation enabling technologies offer the potential to pursue a broad range of therapeutic designs and applications. With proprietary gene editing, cell therapy enabling technologies, and RNA, protein, and vector engineering technologies and the ability to combine them, we can power the entire cell and gene therapy industry.

Learn about our technology

Our Therapeutic Approaches

We have expansive expertise to design, develop and manufacture ex vivo and in vivo cell and gene therapies across an array of modalities.

Learn about our therapeutic designs

What’s New

All News & Pubs

// May 12, 2025

ElevateBio Appoints Ger Brophy, Ph.D., as Interim Chief Executive Officer and Member of the Board of Directors

Read More about ElevateBio Appoints Ger Brophy, Ph.D., as Interim Chief Executive Officer and Member of the Board of Directors

// April 28, 2025

ElevateBio Announces Presentations at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting

Read More about ElevateBio Announces Presentations at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting

Elevated Insights

LETI-101: Life Edit’s Novel Gene Editing Approach to Huntington’s Disease Treatment

By Amy Pooler, Ph.D., SVP, Research and Development of Life Edit

View Insight

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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  • End-to-End Capabilities
    • End-to-End Capabilities Overview
    • cGMP Manufacturing and Automation
    • Process Development
    • Analytical Services and Quality
    • Next-Generation Sequencing
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    • Enabling Services
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    • Technology Platforms Overview
    • Gene Editing
    • Cell Therapy Enabling Technologies
    • RNA, Protein & Vector Engineering
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    • Therapeutic Design & Approaches Overview
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