Optimization of warehouse operations and transport risk mitigation for disposable bioreactor bags to support launch of Amgen Singapore Manufacturing

Abstract

A strategic imperative for Amgen is to increase the number of patients that have access to the company's lifesaving medicines. As part of this goal, Amgen is launching a new manufacturing site in Singapore (ASM). Reliability of supply and quality control will be critical factors for successful ASM launch; therefore, this project will focus on two key objectives: optimization of raw material flow for the ASM warehouse, and transportation risk mitigation of disposable bioreactor bags. Optimization of warehouse operations helps ensure the site can supply enough drug substance to meet the needs of patients worldwide. ASM has a warehouse that is 1/3 the size of a traditional biologics manufacturing warehouse, and is projected to reach capacity during commercial production, increasing risk for the site and incurring the cost of outsourcing storage. A Warehouse Capacity Model was developed using inventory management principles, and then used to identify operations strategies that provide the greatest improvement in warehouse utilization for ASM. Transport risk mitigation for disposable bioreactor bags is critical to the manufacturing process, because ASM is using disposable technology throughout their drug manufacturing process. Even a pin-sized hole can lead to contamination and significant lost revenue. To reduce the risk to these bags during shipping, a twelve-member, cross-functional team was formed, consisting of experts at Amgen from seven different functional groups, including materials science and supply chain, to partner with the supplier to establish a transportation qualification plan for the 2000L bioreactor bag. Transport risk mitigation of bioreactor bags also reduces the required amount of storage, since fewer bags will need to be stored as safety stock. The transport qualification of 2000L bags was successfully executed, and the process was documented to guide future transportation qualification plans for disposables. The key recommendations are that in the short-term, ASM should hold materials with suppliers with warehouses in Singapore, increase frequency of delivery of materials, and utilize random storage location assignment. In the longer term, ASM should utilize storage from suppliers and Third Party Logistics Providers (3PL). For future warehouses, the Warehouse Capacity Model should be used in the design phase to give the team sufficient time to implement recommendations. For future transportation qualification plans for disposables, a pressure decay method is recommended for more robust testing of bag integrity. In addition, creation of a "library" of defects is recommended to improve visual inspections.