Considerations of pool size in the manufacture of plasma derivatives.
BACKGROUND
The pooling of human plasma from many donors for the purpose of manufacturing therapeutic proteins increases the risk of exposing recipients of these proteins to pathogens that may contaminate 1 or a few units included in the pool.


METHODS
This risk is estimated for a range of manufacturing scales that would derive material from a varied number of donors and for a number of hypothetical infectious agents that may exist in the donor population over a wide range of prevalence. Risk is also calculated both for recipients of single doses of a plasma protein and for those who depend on long-term treatment with plasma derivatives.


RESULTS
Risk of exposure increases with pool size and the prevalence of the agent in question and accumulates with repeated treatments with material manufactured from different pools.


CONCLUSIONS
Reducing pool size would at best decrease this risk in proportion to the reduction in manufacturing scale. However, for individuals requiring repeated or continuous treatments, the risk of exposure to all but the rarest infectious agents would be only minimally affected, even by large reductions in manufacturing scale.
Lynch
T J
TJ
Division of Hematology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA.
Weinstein
M J
MJ
Tankersley
D L
DL
Fratantoni
J C
JC
Finlayson
J S
JS
D001798:Blood Proteins / Q000008:administration & dosage; D001803:Blood Transfusion; D003140:Communicable Disease Control / Q000379:methods*; D006801:Humans; D010949:Plasma; D012307:Risk Factors
D001798:Blood Proteins