Company: Atara Biotherapeutics
Liaison(s): Alberto Cosme, Sarim Hul, Taslima Feroud, Seta Toumayan, Daniel Lee
Atara Biotherapeutics is a leading allogeneic T-cell immunotherapy company developing off the shelf treatments for patients with serious diseases. Since its founding in 2012, Atara has cultivated a robust pipeline with therapies for cancer, autoimmune, and viral diseases.
As a part of the FDA’s Pre-Approval Inspection (PAI), Atara is required to have an inventory control program in place to facilitate the transition from clinical to commercialization of their foundational product Tab-cel® (Tabelecleucel). To assist with this transition, the Atara TMP team was tasked with developing and implementing a novel process to manage equipment and spare part inventory critical for manufacturing operations.
The Atara TMP team generated a list of critical spare parts with specifications, developed a process for classifying equipment and part criticality, established an inventory control program, and formulated a stock location plan. Completion of this project enables Atara to streamline their inventory management initiatives, thus supporting current and future cell therapy operations at multiple facilities. Additionally, the Atara TMP team has supported adoption and integration of these processes into the existing system at Atara.