IMC-2018 Learning Session 38:48

by Joseph Tyska, Bristol-Myers Squibb

Bristol-Myers Squibb (BMS) focuses on its mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. BMS is a pioneering organization in the field of immuno-oncology, harnessing the power of a person's immune system to help fight cancer. At the BMS Hopewell Clinical Manufacturing (HCM) facility, immuno-oncology (IO) drug substances are manufactured for first in human clinical trials. Sixty percent of the company's IO pipeline is manufactured in HCM. At HCM, biologics drug substance involves the growth of host cells to produce the protein drug substance. Once the growth process is started, it cannot be stopped until final harvest when the protein medicines are extracted from the host cells. The cell growth process is a 24/7 operation for approximately 28 days. HCM has two production wings, with multiple concurrent campaigns. Reliable production and support equipment is critical to BMS success. All of the HCM production activities conducted under current Good Manufacturing Practices (cGMP) and subject to FDA scrutiny. Once every 18 months production activities are shutdown to address critical utility system preventive maintenance needs. During this shutdown period, all capital and expense reliability, sustainability, and environmental projects delayed by production schedules are simultaneously executed. This presentation captures the planning, scope, and lessons learned from the 2016 HCM shutdown, spending $4MM+ in six weeks and return to service of clinical manufacturing production.