Closed system processing variables affect post-thaw quality characteristics of cryopreserved red cell concentrates

Area of Science:

• Blood banking and transfusion medicine
• Cellular cryopreservation and processing
• Biomaterials and additive solutions

Background:

• Manufacturing conditions for the Haemonetics ACP 215 cell processor impact cryopreserved red cell concentrate (RCC) quality.
• Variability in RCC quality necessitates identifying optimal manufacturing protocols.

Purpose of the Study:

• To investigate the effects of processing methods, additive solutions, and storage durations on RCC quality.
• To determine an optimal protocol for manufacturing high-quality cryopreserved RCCs.

Main Methods:

• Red cell concentrates (RCCs) were stored for 7, 14, or 21 days before cryopreservation using single or dual centrifugation.
• Post-thaw processing involved deglycerolization and suspension in AS-3, SAGM, ESOL, or SOLX/AS-7.
• Quality assessments included hemoglobin, hematocrit, hemolysis, ATP, potassium, and mean cell volume.

Main Results:

• Both glycerolization methods met regulatory standards; dual centrifugation yielded higher hemoglobin and shorter deglycerolization times.
• AS-3 and ESOL maintained RCC quality for up to 21 days pre- and post-cryopreservation.
• ESOL showed superior adenosine triphosphate (ATP) maintenance compared to AS-3; SAGM and SOLX exceeded hemolysis limits.

Conclusions:

• Dual centrifugation processing with AS-3 or ESOL is recommended for manufacturing cryopreserved RCCs via the ACP 215.
• Optimal storage periods extend up to 21 days pre-processing and 21 days post-deglycerolization.
• This protocol ensures high-quality cryopreserved RCCs meeting regulatory standards.