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.

I: Science, Bind 369, Nr. 6506, 13.08.2020, s. 912-914.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Price II, WN, Rai, A & Minssen, T 2020, 'Knowledge transfer for large scale vaccine manufacturing', Science, bind 369, nr. 6506, s. 912-914. https://doi.org/10.1126/science.abc9588

APA

Price II, W. N., Rai, A., & Minssen, T. (2020). Knowledge transfer for large scale vaccine manufacturing. Science, 369(6506), 912-914. https://doi.org/10.1126/science.abc9588

Vancouver

Price II WN, Rai A, Minssen T. Knowledge transfer for large scale vaccine manufacturing. Science. 2020 aug 13;369(6506):912-914. https://doi.org/10.1126/science.abc9588

Author

Price II, William Nicholson ; Rai, Arti ; Minssen, Timo. / Knowledge transfer for large scale vaccine manufacturing. I: Science. 2020 ; Bind 369, Nr. 6506. s. 912-914.

Bibtex

@article{48ee219077964de89c04a9272091c944,
title = "Knowledge transfer for large scale vaccine manufacturing",
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{\textquoteright} 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{\textquoteright}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.",
keywords = "Faculty of Law, COVID-19, Vaccine, Trade Secrets, knowledge transfer, biologics, manufacturing",
author = "{Price II}, {William Nicholson} and Arti Rai and Timo Minssen",
year = "2020",
month = aug,
day = "13",
doi = "10.1126/science.abc9588",
language = "English",
volume = "369",
pages = "912--914",
journal = "Science",
issn = "0036-8075",
publisher = "American Association for the Advancement of Science",
number = "6506",

}

RIS

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