Apheresis
Providing needle-to-needle support for your products within your own development and manufacturing process
// End-to-end
Capabilities
Tailored Services to Match Your Innovative Therapies
We recognize the importance of apheresis and the collection of quality starting materials in the development and production of your innovative therapies. With our team of experts, we ensure precise and compliant apheresis processes tailored to the unique requirements of your project – from patient collection through manufacturing and re-administration – facilitating the seamless execution of apheresis procedures and progression of your clinical trials.
Apheresis
Site IdentificationWe have relationships established with a vast network of apheresis collection sites nationally and internationally. We provide in-depth profiles of apheresis centers and develop mitigation strategies for disparities and variabilities, ensuring that your clinical trial operates at its optimal potential. |  |
Process & Procedure DevelopmentWe can help establish sponsor control over multiple collection sites in alignment with regulatory guidance. Our experts define disease and trial-specific parameters to optimize collection efficiencies, ensuring reproducible results across collection sites. Our team of experts provide comprehensive documentation for collection guidance, labeling, sampling, packing, shipment, and adverse reporting. Together, we can help guide your collection sites through disease-specific processes and complex apheresis procedures, ensuring that every step is executed with precision and compliance. |  |
Collection AnalyticsOur data-driven approach analyzes collection procedure data to optimize future collections. We conduct a comprehensive assessment inclusive of patient data, collection data, and product data. The result is a set of recommendations for parameter and/or procedural changes, along with a comparative analysis of collection efficiencies across all sites within your clinical trial or commercial apheresis network. |  |
Site Qualification & RequalificationWe conduct regular quality audits and technical assessments to satisfy regulatory requirements, ensuring that your chosen site performs processes in a safe and compliant manner. We work with Foundation for the Accreditation of Cellular Therapy (FACT) accredited organizations as well as non-FACT organizations, easing the burden of collecting sites and providing audits and assessments you can trust. |  |
Training & Collection SupportOur experts provide onsite or remote support on the day of collection, assisting from patient arrival to packaged apheresis product handoff to the courier. This includes process support, document completion support, personalized team training, and technical support tailored to your clinical trial specifics, and real-time sponsor updates. |  |
Our Therapeutic Approaches
We are enabling the development of a range of ex vivo and in vivo cell and gene therapies, leveraging our in-house capabilities and expertise to design and develop an array of modalities.
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.
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
