Knowledge transfer for large-scale vaccine manufacturing

TLDR

The rapid development of COVID‑19 vaccines has shifted focus to large‑scale manufacturing, which requires both production capacity and proprietary process knowledge beyond patents. This paper examines how DOJ‑approved rapid technical information exchange could address current manufacturing challenges and foster a future of reduced silos, greater standardization, and less secrecy. Six biopharmaceutical firms were granted DOJ permission to share technical manufacturing details under antitrust law, allowing them to exchange process information while protecting cost and pricing data.

Abstract

As the world rushes to identify safe and effective vaccines and therapeutics to counter the COVID-19 epidemic, attention is turning to the next step: manufacturing these products at enormous scale. To speed up the process, firms are even es-tablishing manufacturing capacity “at risk,” before products receive regulatory approval (1). Yet for at least some complex COVID-19 vaccines and biological thera-peutics, fast manufacturing, particularly of products originally developed by other firms, will require not only physical capaci-ty but also access to knowledge not con-tained in patents or in other public disclo-sures. Indeed, one reason for the expense and delay historically associated with en-try of biosimilars into the market has been the cost and time associated with reverse engineering originator firms’ manufacturing processes (2). But seeds of change may be emerging. A group of six biopharmaceutical firms researching monoclonal antibody (mAb) candidates recently sought (and the U.S. Department of Justice (DOJ) granted) permission un-der antitrust law to exchange “technical information” on each other’s manufactur-ing processes and platforms (but not in-formation on cost or price) (3). Here we discuss whether and how a focus on rapid information exchange of the sort recently encouraged by the DOJ will not only be critical for the current crisis but could al-so create the foundation for fewer siloes, improved standardization, and less secre-cy over manufacturing information in the future.