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. 2020 May;38(5):540-545.
doi: 10.1038/s41587-020-0512-5.

Developing therapeutic monoclonal antibodies at pandemic pace

Brian Kelley  1
Affiliations

Developing therapeutic monoclonal antibodies at pandemic pace

Brian Kelley. Nat Biotechnol. 2020 May.

Abstract

The time from discovery to proof-of-concept trials could be reduced to 5–6 months from a traditional timeline of 10–12 months.

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Conflict of interest statement

The author is employed by Vir Biotechnology, which is developing monoclonal antibodies for the treatment of pandemic diseases, such as COVID-19 and influenza.

Figures

Fig. 1
Fig. 1. Accelerated phase 1 CMC mAb timeline for a pandemic.
The timeline to phase 1 clinical studies using mAb therapeutics for pandemic outbreaks can be substantially accelerated without heightened product safety risks as compared with current practice. Tox, toxicology; MCB, master cell bank; DS, drug substance; DP, drug product; PD, process development; form, formulation; AD, analytical development.
Fig. 2
Fig. 2. mAb product development for pandemics (mAb lead identification to BLA).
The fastest path to licensure for therapeutic mAbs treating pandemic outbreaks requires accepting business risks and preinvestment, but without major product quality, supply and regulatory risks.
See this image and copyright information in PMC

Comment in

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