cGMP Manufacturing and Automation
End-to-end solutions for cGMP manufacturing across the entire cell and gene therapy 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 cell and gene therapy 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.
Didier Zuendoki
Director, QA Compliance
Jonathan Bairam
Associate Director, Cell Therapy Manufacturing
Nate Cyr
Senior Manager, Laboratory & Site Services
cGMP Manufacturing and Automation
Clinical and Commercial ManufacturingOur manufacturing process is designed to accelerate and optimize the development of cell and gene 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. |  |
Process ValidationWith 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 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 AffairsBaseCamp 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 manufacturing expertise supports our broad portfolio of enabling technologies and therapeutic platforms. Spanning gene editing, iPSCs, and RNA, cell, protein, and vector technologies, we can be your cell and gene therapy one-stop-shop.
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.
Elevated Insights
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.
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