The OrganaBio method for cultivation of a highly recallable leukapheresis donor pool
OrganaBio and its wholly-owned leukapheresis collection subsidiary, HemaCenter, have designed processes and procedures to curate and maintain a highly recallable donor pool. Access to robust, reliable cellular starting materials is critical to the success of a cell therapy program, and donor recallability is one of the largest challenges facing cell therapy developers who rely on […]
The OrganaBio cGMP Manufacturing Facility (Miami, FL) – Manufacturing with Clinical Translation in Mind
Current good manufacturing practice (cGMP) is a set of regulations instituted and enforced by the U.S. Food and Drug Administration (FDA) that “assure proper design, monitoring, and control of manufacturing facilities and establish minimum requirements for any manufacturing process.” When a company is following cGMP standards it assures “identity, strength, potency, and purity of drug […]
Know More About HLA Typing
While Human Leukocyte Antigen (HLA) matching is often emphasized in the context of bone marrow and organ transplant, HLA typing is used to identify disease-related biomarkers and predict immune responses, including those that could lead to cell rejection and/or graft-versus-host disease (GvHD), which is why researchers are interested in HLA phenotyping and genotyping of cellular starting material. […]