In 2015, the U.S. Food and Drug Administration approved the monoclonal antibodies daratumumab and elotuzumab for treating multiple myeloma (MM). However, most patients’ disease eventually progresses.
To enhance anti-tumor mechanisms and tumor killing, researchers have identified a novel subset of human NK cells that have increased ADCC activity following NK Fe receptor crosslinking. This special NK cell subset is only detectable in 25 – 30% of CMV seropositive individuals.
Our client has developed an expansion method to allow scale up and manufacturing of these unique NK cells as an off-the-shelf, allogeneic cell therapy. To obtain these NK cells, our client required a steady supply of fresh leukopaks from CMV seropositive donors.
OrganaBio rose to the challenge and quickly sourced 100 CMV+ donors for screening and donor qualification. These selected donors’ RUO and GMP LeukoPACs were then drawn and shipped fresh to the client’s COMO in Singapore – providing a tailored and time-sensitive solution.
PROJECT OVERVIEW
OrganaBio was approached by a client for a multi-phase project involving extensive CMV seropositive donor screening for an IND application. To start, the client needed 100 PBMC vials from leukapheresis. The subsequent phases of the project included collections of RUO and GMP leukopaks from donors with specific phenotypic and functional requirements.
To maximize efficiency and cost-effectiveness, the OrganaBio team proposed whole blood draws instead of full leukapheresis collections, thus allowing donors to return sooner for a full collection. HemaCenter, LLC, OrganaBio’s wholly-owned leukapheresis subsidiary, was responsible for donor recruitment, screening, and sample collections.
PROJECT MANAGEMENT
OrganaBio’s dedicated project manager skillfully coordinated Sales, Process Development, and Operations teams with HemaCenter staff to ensure the timely completion of the project. Bi-weekly meetings with the client kept them informed and up-to-date on project progress, while a project management software allowed them to view all donor attributes, sample characteristics, and note which donors were critical to their process. This enabled the client to have 24/7 access to project progress, ensuring clear, comprehensive, and timely communications.
About OrganaBio
OrganaBio is revolutionizing the cell therapy and immunotherapy industries with its cutting-edge Contract Technology Development Manufacturing Organization (CTDMO) model. Our company provides everything you need to develop, test, and manufacture cell therapies, from tissue supply chains and cellular starting materials to expert guidance and cGMP-compliant facilities.
We’re passionate about ethically accelerating the deployment of cell therapies, and we’re dedicated to ensuring that our clients have the resources they need to move quickly and cost-effectively from pre-clinical to clinical phases. With OrganaBio, you can trust that your journey to therapeutic translation will be seamless and successful.