Knowledge transfer for large-scale vaccine manufacturing

• Published in: Science 2020-08, Vol.369 (6506), p.912-914
• Main Authors: Price, W. Nicholson, Rai, Arti K., Minssen, Timo
• Format: Article
• Language: English
• Subjects: Biopharmaceuticals; Coronaviruses; COVID-19; COVID-19 vaccines; Federal agencies; Information transfer; Knowledge management; Manufacturing; Manufacturing industry; Monoclonal antibodies; Pandemics; Regulatory approval; Reverse engineering; Standardization; Technical information; Vaccines; Viral diseases
• ISSN: 0036-8075; 1095-9203
• DOI: 10.1126/science.abc9588

Massive, rapid production will require firms to share know-how not just about what to make but how to make it As the world rushes to identify safe and effective vaccines and therapeutics to counter the coronavirus disease 2019 (COVID-19) pandemic, attention is turning to the next step: manufacturing these products at enormous scale. To speed up the process, firms are even establishing manufacturing capacity “at risk,” before products receive regulatory approval ( 1 ). Yet for at least some complex COVID-19 vaccines and biological therapeutics, fast manufacturing, particularly of products originally developed by other firms, will require not only physical capacity but also access to knowledge not contained in patents or in other public disclosures; one reason for the expense and delay historically associated with entry of biosimilars into the market has been the cost and time associated with reverse engineering originator firms' manufacturing processes ( 2 ). But a change may be coming. A group of six biopharmaceutical firms researching monoclonal antibody (mAb) candidates recently sought [and the U.S. Department of Justice (DOJ) granted] permission under antitrust law to exchange “technical information” on each other's manufacturing processes and platforms (but not information on cost or price) ( 3 ). 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 also create the foundation for fewer siloes, improved standardization, and less secrecy over manufacturing information in the future.