Plasma and cryoprecipitate manufactured from whole blood held overnight at room temperature meet quality standards.
BACKGROUND
With buffy coat (BC) processing of whole blood (WB) donations, the preparation of plasma occurs within 24 hours rather than 8 hours of collection. The effect of this change on coagulation factor function in plasma and cryoprecipitate was evaluated during the validation of this production method and with routine production.


METHODS
Plasma frozen after an overnight hold of WB was prepared via BC or whole blood filtration (WBF) methods and quality control (QC) variables were measured. Additionally, plasma prepared with the BC method was compared to plasma produced using the platelet-rich plasma (PRP) method with an extended plasma factor analysis. Selected plasma factor levels were also measured in both cryoprecipitate and cryosupernatant plasma prepared using the WBF method from plasma frozen on the day of collection or after an overnight hold of WB.


RESULTS
When comparing BC plasma to PRP plasma, coagulation factors (F)II, VII, VIII, IX, X, and XI had somewhat lower levels, and fibrinogen and antithrombin levels were elevated. As expected the most sensitive to the prolongation of production time was FVIII with 72 and 78% of the activity of PRP plasma and cryoprecipitate, respectively. However, both still met QC standards. Similarly, products made in routine production show acceptable levels of FVIII.


CONCLUSIONS
Plasma and cryoprecipitate products, prepared using methods in which the plasma is frozen close to 24 hours after collection, meet current quality standards. The longer WB storage time has been implemented into general use in Canada.
Serrano
Katherine
K
Research and Development, Canadian Blood Services, Vancouver, British Columbia, Canada.
Scammell
Ken
K
Weiss
Sandra
S
Culibrk
Brankica
B
Levin
Elena
E
Gyöngyössy-Issa
Maria
M
Devine
Dana V
DV
D000991:Antithrombins / Q000032:analysis; D001771:Blood Banks / Q000592:standards; D001779:Blood Coagulation Factors / Q000032:analysis; D001781:Blood Component Removal / Q000191:economics / Q000379:methods* / Q000592:standards; D001792:Blood Platelets / Q000166:cytology; D001793:Blood Preservation / Q000379:methods*; D001955:British Columbia; D002470:Cell Survival; D002498:Centrifugation; D015925:Cryopreservation; D016238:Cytapheresis / Q000379:methods / Q000592:standards; D005169:Factor VIII / Q000592:standards*; D005340:Fibrinogen / Q000032:analysis / Q000592:standards*; D005374:Filtration; D006801:Humans; D047589:Leukocyte Reduction Procedures; D010949:Plasma; D053657:Platelet-Rich Plasma; D055550:Protein Stability; D013696:Temperature; D013997:Time Factors
D000991:Antithrombins; D001779:Blood Coagulation Factors; C026912:cryoprecipitate coagulum; D005169:Factor VIII; D005340:Fibrinogen