Knowledge transfer for large scale vaccine manufacturing
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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.
|Status||Udgivet - 13 aug. 2020|
- Det Juridiske Fakultet