cGMP Manufacturing and Automation
Manufacture from preclinical through commercial scale without switching facilities or re-optimizing your process.
// cGMP Manufacturing
and Automation
Manufacturing Your Vision
Our BaseCamp® cGMP manufacturing facility in Waltham, MA is built with multiple segregated manufacturing suites for cell therapy products, viral vectors, and mRNA — designed so partners can move from development through commercial production without a disruptive handoff.
We manufacture across three modalities:
Cell Therapies
Autologous and allogeneic programs from process development through cGMP production.
Viral Vectors
Lentiviral and AAV manufacturing at multiple production scales.
mRNA
Drug substance and drug product manufacturing at any stage of development.
Our Full Spectrum of cGMP Production Solutions
Partners have access to end-to-end manufacturing capabilities across cell therapy, viral vector (lentiviral and AAV), and mRNA — with the process development, analytical, and regulatory infrastructure to support programs from first-in-human through commercial supply.
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Clinical and Commercial ManufacturingOur manufacturing process is designed to accelerate and optimize the development of advanced therapies. 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 TransferOur 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. |  |
Supply Chain ManagementCell 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 AffairsElevateBio provides the necessary Chemistry, Manufacturing and Controls (CMC) functions, all under one roof. Our regulatory experts have a 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 Facilities
Two purpose-built BaseCamp cGMP manufacturing facilities — Waltham, MA and Pittsburgh, PA — designed from the ground up for advanced medicines manufacturing.
Partner with ElevateBio®
Wherever you are in your advanced therapy product lifecycle, we can strengthen and accelerate your development journey with our enabling technologies and unmatched process development and manufacturing capabilities.
// Work with us
