The landscape of knowledge about human disease is rapidly expanding. Advances in our abilities to learn directly from clinical samples about diseases using new technologies and computational tools are accelerating these insights. Such precision expands our ability to identify rare diseases, stratify patients by indication, and improve the efficiency of clinical studies to establish efficacy of products. This transformation in how we develop and assess new drugs will further accentuate the need for efficiency, speed, and agility in our manufacturing strategies of high-quality recombinant biopharmaceuticals. This talk will consider the evolution of manufacturing strategies in related industries where shifts in market size and product diversity have led to changes in the underlying manufacturing networks, and examine the opportunities for the design of facilities and process engineering to keep pace with small-volume production. It will highlight a few examples and lessons learned from developing small-scale automated manufacturing systems for high-quality recombinant protein drugs, including how a deep ‘-omic level’ understanding of the biology of manufacturing (e.g, the host itself) accelerates predictable process development for both upstream and downstream operations. In total, holistic integration of knowledge about biology and engineering can facilitate rapid process development and speed manufacturing of high-quality products at scales relevant for a variety of use cases. Finally, the potential impact will be discussed for an open “Maker”-style platform approach to realize recombinant drugs anywhere in order to accelerate access to new medicines.

Innovating biopharmaceutical manufacturing for an age of acceleration

255th National Meeting (2018)

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