Year: 2022-23

Company: Abzena

Liaison(s): Kevin Shaabani

Abzena is a globally recognized biopharmaceutical company that offers a wide variety of services and technologies aimed at supporting the discovery, development, and production of biopharmaceutical products. With extensive expertise in protein engineering, process development, and GMP manufacturing, Abzena serves a diverse client base in the biopharmaceutical industry, including large pharmaceutical companies, small biotech firms, and academic research institutions. The company’s goal is to assist its clients in bringing new treatments to patients in a timely and efficient manner by providing the necessary tools and expertise to advance their programs from discovery to commercialization. With a strong emphasis on quality and innovation, Abzena is poised for continued growth as a leading player in the biopharmaceutical industry. The Abzena TMP was tasked with creating Standard Work procedures that enhance vital operations at the Abzena San Diego cGMP facility. The TMP group played a key role in pinpointing and working closely with technical, manufacturing, and quality teams to enhance the performance of crucial unit operations. This team worked closely with significant departments to establish standard work, capturing the most efficient and compliant methods of performing a task as it is currently known and carried out by trained personnel. In addition, the TMP team assessed the risk associated with these critical process steps to better plan a risk mitigation strategy that will in turn improve production success.