Company: Kite Pharma
Liaison(s): Kyle Carter, David Myers, Toya Robinson, Tam Soden
Kite Pharma, a Gilead company, is a global biopharmaceutical company and a renowned leader in the treatment of B-Cell malignancies. Founded in 2009, Kite developed a technology using genetically engineered autologous T-Cell therapy with chimeric antigen receptors, also known as CAR-T Cell therapy, as a cancer treatment. Yescarta® is one of Kite’s leading products approved by the FDA to treat B-Cell acute lymphoblastic leukemia (B-ALL), diffuse B-cell lymphoma (DLBCL), and non-Hodgkin B-cell refracting or relapsing lymphoma. The Kite Global Quality Control (QC) department is responsible for the implementation and oversight of a comprehensive test method strategy for In-Process Controls, Raw Materials, Drug Substance, and Drug Product. Kite leverages a variety of systems to incorporate, aggregate, and report on QC data but lacks a holistic and robust process for timely oversight and continuous improvement of their test method portfolio. The Kite TMP team was tasked with the establishment of a tool for data management and analysis to drive a deeper understanding of Kite’s laboratory method, execution, performance, and test results. To accomplish this objective, the Kite TMP team worked with Kite subject matter experts to identify areas of improvements in the current manual QC data analysis process. This tool will positively impact the efficiency and data integrity of the product quality monitoring process. The project output will serve as a prototype specific to QC data management and could potentially be utilized throughout the Quality organization.