Enabling Services
Providing end-to-end expert support capabilities for cell and gene therapies.
// End-to-end
Capabilities
Enabling Your Vision for the Future
We provide the scientific, technological, and regulatory expertise to innovate, develop, and accelerate life-transforming therapies. Our team of seasoned drug developers provides guidance and partners with you throughout every step of the development and manufacturing process, providing a variety of enabling services to advance your program.
Enabling Services
Regulatory CMC SupportWe incorporate regulatory support at the very beginning of product development journey and through the entire clinal and commercialization lifecycle to ensure we meet regulatory standards. We provide support across a range of CMC activities to ensure product consistency and future success in your regulatory filings. |
ApheresisWe can provide ‘needle to needle’ support for your products, including managing apheresis and incorporating it within your development and manufacturing process. |
R&D
Supporting Your Drug Discovery and Clinical Development
We leverage our drug development experience to accelerate the design, manufacturing and development of your products, from discovery through clinical development.
Our Research & Development expertise includes:
- Discovery services, including: vector design, process development, and assay development
- Clinical development support, including: process scale up, cGMP clinical supply, assay development, qualification and validation, and release testing
- Protein engineering, including: the development of antigen receptors, binders, and endonucleases, enabled by our platform technologies
Providing Regulatory Support, From the Start
We incorporate regulatory support at the very beginning of product development journey and through the entire clinical and commercialization lifecycle to ensure we meet regulatory standards. We provide support across a range of CMC (Chemistry, Manufacturing, and Controls) activities to ensure product consistency and future success in your regulatory filings. By integrating regulatory considerations into every stage of the development process, we mitigate risks and optimize timelines for approval. Our deep understanding of global regulatory requirements and our track record of success make us a trusted partner in navigating the complex landscape of regulatory affairs.
Our Technology Platforms
Our next-generation enabling technologies and platforms offer the potential to pursue a broad range of therapeutic designs and applications. With proprietary gene editing, cell therapy, and RNA, protein, and vector technologies and the ability to combine them, we can power the entire cell and gene therapy industry.
Our Therapeutic Approaches
We are enabling the development of a range of genetic medicines, leveraging our in-house capabilities and expertise to design and develop an array of modalities.
Elevated Insights
Introducing ElevateBio’s Emerging Technology Lab
By Mercedes Segura, PhD, VP, Process Development, ElevateBio BaseCamp
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.
// Work with us