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# Support for Convalescent Plasma Registries
- URL: https://www.fdaweb.com/support-for-convalescent-plasma-registries/
- Published: 2023-11-08T12:00:00.000Z
- Updated: 2026-09-14T14:15:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155748

CBER director **Peter Marks** and researchers from three academic medical centers say that registries used in the U.S. and several other countries to track the use of Covid-19 convalescent plasma (CP) showed that CP was effective when used early and with high titer. Writing in an *mBio* [editorial](https://journals.asm.org/doi/10.1128/mbio.02565-23?ref=fdaweb.com), the authors say that in an accompanying article, registry data found that administration of high titer CP earlier in the course of hospitalization was associated with better clinical outcomes.

The report says three caveats must be considered with the overarching lesson about CP therapy:

- CP from recovered patients is likely to be the first form deployable of antibody therapy during the next pandemic or infectious disease emergency;
- while CP will almost certainly be available during the next crisis, there may be challenges with assaying and standardizing the amount and quality of the antibodies it contains, so high priority needs to be given to the rapid development of assays to determine viral neutralization capacity or antibody levels in CP; and
- the fundamentals of antibody therapy, well established before World War II and rediscovered during the Covid-19 pandemic, should not be forgotten again.

The authors say that when the big lesson and three caveats about antibody therapy in general and CP in specific are considered as a whole, a flexible, pre-planned approach to early registry-based data collection could be lifesaving during the next infectious disease emergency. They suggest an approach covering these points:

- the focus of treatment with CP in any infectious disease emergency should be early after symptoms arise;
- regulators and funding agencies should be involved in the pre-planning and development of simple CP administration protocols and their oversight;
- mechanisms including funding should be in place so the blood collection and banking system can obtain CP from qualified recovered donors as soon as they become available;
- a diverse network of sites should be available for the administration of CP with pre-established ground rules for a central institutional review board, patient consent, and the reporting of fundamental patient outcomes;
- a data management system and analytics team should be in place to facilitate rapid reporting of results;
- simulation exercises should be performed to test the system; and
- all elements of the program should focus on simplicity, remembering that the axiom of crisis-based medical care — the enemy of good is perfect — must be rigorously adhered to.