End-to-end collaboration to transform biopharmaceutical development and manufacturing

Abstract

An ambitious 10-year collaborative program is described to invent, design, demonstrate, and support commercialization of integrated biopharmaceutical manufacturing technology intended to transform the industry. Our goal is to enable improved control, robustness, and security of supply, dramatically reduced capital and operating cost, flexibility to supply an extremely diverse and changing portfolio of products in the face of uncertainty and changing demand, and faster product development and supply chain velocity, with sustainable raw materials, components, and energy use. The program is organized into workstreams focused on end-to-end control strategy, equipment flexibility, next generation technology, sustainability, and a physical test bed to evaluate and demonstrate the technologies that are developed. The elements of the program are synergistic. For example, process intensification results in cost reduction as well as increased sustainability. Improved robustness leads to less inventory, which improves costs and supply chain velocity. Flexibility allows more products to be consolidated into fewer factories, reduces the need for new facilities, simplifies the acquisition of additional capacity if needed, and reduces changeover time, which improves cost and velocity. The program incorporates both drug substance and drug product manufacturing, but this paper will focus on the drug substance elements of the program.

Keywords: biopharmaceutical; continuous bioprocess; factory of the future; innovation; manufacturing; process intensification; technology.

Figure 1

High‐level technology strategy. First generation processes have already been developed but still need to be adopted into commercial manufacturing. Second generation processes will provide intermediate benefits. Third generation processes will deliver the 10‐year vision, but the underlying technology needs to be invented before they can be developed

Figure 2

Three‐pronged strategy of flexibility workstream: playbook, toolbox, demonstration

Figure 3

The sustainability workstream 10‐year vision for carbon neutral bioprocessing, including milestones and potential output examples

Figure 4

Consensus continuous platform process for test bed