Broad-spectrum virus reduction in red cell concentrates using INACTINE PEN110 chemistry

Area of Science:

• Blood banking and transfusion medicine
• Virology and infectious diseases
• Biotechnology and chemical inactivation

Background:

• Transmission of blood-borne pathogens via transfusion remains a significant medical safety concern.
• Developing effective pathogen-reduction technologies for blood products is crucial for transfusion safety.
• INACTINE PEN110 chemistry offers a novel approach to pathogen reduction in red blood cell concentrates (RBCC).

Purpose of the Study:

• To evaluate the virucidal efficacy of INACTINE PEN110 chemistry in whole units of RBCC.
• To assess the effectiveness against a diverse panel of enveloped, non-enveloped, and cell-associated viruses.
• To characterize the inactivation kinetics and robustness of the PEN110 treatment process.

Main Methods:

• A comprehensive panel of 11 viruses (4 enveloped, 6 non-enveloped, 1 cell-associated) was used.
• Viruses were spiked into RBCC units stored with different solutions (CPD/AS-1, CP2D/AS-3, CPD/AS-5) and treated with 0.1% PEN110.
• Virus reduction was quantified after chemical quenching, accounting for potential cytotoxicity and interference.

Main Results:

• INACTINE PEN110 demonstrated broad-spectrum virucidal activity, reducing all tested viruses to assay detection limits.
• Virus inactivation kinetics were consistent across different RBCC storage solutions.
• Reduction factors for the virus panel ranged from 4.2 to 7.5 log10/ml.

Conclusions:

• INACTINE PEN110 chemistry provides a broad-spectrum pathogen-reduction solution for RBCC, effective against diverse viral types.
• The technology shows robust performance, with consistent inactivation kinetics regardless of RBC storage solutions.
• This study validates INACTINE PEN110 as a promising technology for enhancing the safety of blood transfusions.