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 […]
Developing a Robust CGT Manufacturing Process
In this presentation, OrganaBio’s Head of Process & Product Development highlights our approach to setting the stage early in process development for sustained manufacturing success. This talk was originally given at the 2020 Cell & Gene Therapy Bioprocessing & Commercialization global conference. The conference brought together 856 members of the cell and gene therapy community […]