Knowledge transfer for large scale vaccine manufacturing
(2020) In Science 369(6506). p.912-914- 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... (More)
- 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. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/3f4e6bc6-b79f-4e80-bbe5-b584a029a34b
- author
- Price II, William Nicholson ; Rai, Arti and Minssen, Timo LU
- publishing date
- 2020-08-13
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Health law, COVID-19, Hälsorätt
- in
- Science
- volume
- 369
- issue
- 6506
- pages
- 3 pages
- publisher
- American Association for the Advancement of Science (AAAS)
- external identifiers
-
- pmid:32792464
- scopus:85089786771
- ISSN
- 0036-8075
- DOI
- 10.1126/science.abc9588
- language
- English
- LU publication?
- no
- id
- 3f4e6bc6-b79f-4e80-bbe5-b584a029a34b
- date added to LUP
- 2020-12-16 13:11:34
- date last changed
- 2022-04-26 22:36:54
@article{3f4e6bc6-b79f-4e80-bbe5-b584a029a34b,
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.}},
author = {{Price II, William Nicholson and Rai, Arti and Minssen, Timo}},
issn = {{0036-8075}},
keywords = {{Health law; COVID-19; Hälsorätt}},
language = {{eng}},
month = {{08}},
number = {{6506}},
pages = {{912--914}},
publisher = {{American Association for the Advancement of Science (AAAS)}},
series = {{Science}},
title = {{Knowledge transfer for large scale vaccine manufacturing}},
url = {{http://dx.doi.org/10.1126/science.abc9588}},
doi = {{10.1126/science.abc9588}},
volume = {{369}},
year = {{2020}},
}