Knowledge transfer for large scale vaccine manufacturing
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Knowledge transfer for large scale vaccine manufacturing. / Price II, William Nicholson; Rai, Arti; Minssen, Timo.
In: Science, Vol. 369, No. 6506, 13.08.2020, p. 912-914.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Knowledge transfer for large scale vaccine manufacturing
AU - Price II, William Nicholson
AU - Rai, Arti
AU - Minssen, Timo
PY - 2020/8/13
Y1 - 2020/8/13
N2 - 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.
AB - 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.
KW - Faculty of Law
KW - COVID-19
KW - Vaccine
KW - Trade Secrets
KW - knowledge transfer
KW - biologics
KW - manufacturing
UR - https://science.sciencemag.org/content/early/2020/08/12/science.abc9588?rss=1
U2 - 10.1126/science.abc9588
DO - 10.1126/science.abc9588
M3 - Journal article
C2 - 32792464
VL - 369
SP - 912
EP - 914
JO - Science
JF - Science
SN - 0036-8075
IS - 6506
ER -
ID: 241642229