Optimized Protocol for Producing Pathogen-inactivated Double-dose Platelet Concentrates From Six Pooled Buffy Coats.

Area of Science:

• Transfusion Medicine
• Blood Component Manufacturing
• Hematology

Background:

• Pooled platelet (PLT) production varies globally, with Europe predominantly using the buffy coat (BC) method.
• European regulations define a therapeutic PLT unit as ≥ 2 × 10¹¹ PLTs/unit.
• Current methods require optimization for enhanced production efficiency and quality.

Purpose of the Study:

• To optimize manufacturing steps for producing double-dose PLT products from six BCs.
• To enhance production efficiency while maintaining product quality and regulatory compliance.

Main Methods:

• Stepwise protocol optimization starting with five BCs, progressively adding a sixth BC.
• Utilization of a hematology analyzer (Sysmex XN-1000) with blood bank mode for precise PLT count measurement.
• Optimization of blood cell separator (BCS) settings and centrifugation parameters.
• Pathogen inactivation using the INTERCEPT blood system (amotosalen/ultraviolet A).

Main Results:

• Each optimization step significantly increased PLT yield (P <0.001).
• Mean yield increased from 2.83 (SD 0.39) for five BCs to 4.81 (SD 0.58) for six BCs with optimized methods.
• Mean BC volume increased from 47.78 mL to 55.59 mL following BCS adaptations (P <0.001).

Conclusions:

• Stepwise protocol optimization enables the production of pathogen-inactivated double-dose PLT concentrates from six BCs.
• The optimized method complies with national regulations and EDQM quality requirements.
• The enhanced protocol reduces costs and minimizes blood wastage in PLT production.