SITUATION
In response to the urgent need for increased domestic fill-finish capacity for potential COVID-19 vaccines, ApiJect partnered with The Ritedose Corporation (TRC) in 2020. The collaboration, initiated under the U.S. Government's Project Jumpstart, aimed to operationalize a Single-Dose Drug Delivery Fill-Finish Facility capable of producing up to 45 million Blow-Fill-Seal (BFS) units per month within an accelerated timeline of fewer than seven months.
SOLUTION
ApiJect and TRC successfully upgraded three existing BFS lines at TRC's Columbia, South Carolina facility to bio-safety level 2 (BSL-2) conditions, aligning with the government's requirements. This involved modifying air handling systems, adding airlocks, introducing an autoclave for waste decontamination, and implementing a Biokill system. ApiJect also upgraded BFS machines and collaborated closely with TRC to align design and construction teams. The project was executed on an aggressive timeline, overcoming challenges in procuring necessary equipment such as the decon autoclave and Biokill system.
IMPACT
ApiJect met the HHS/DOD timetable for Project Jumpstart, achieving operational status for the first BFS line on October 30, 2020, and the second line a month later. This collaboration provided the U.S. Government with a domestic surge capacity, enabling the fill-finish of 45 million BFS containers per month with sterile liquid pharmaceuticals within a BSL-2 environment. The successful execution of the project within the accelerated timeline stands as a testament to the collaborative efforts between ApiJect and TRC, showcasing the effectiveness of their partnership under challenging circumstances.
