Updated April 27, 2021:
Biopharmaceuticals such as monoclonal antibodies, proteins, vaccines, etc., are one of the most effective public health medicinal products with an excellent safety record by inducing potent and long-lasting immune responses against infectious agents. These would likely be prioritized for health-care workers and people at greatest risk of severe illness and death. There is a need to safeguard the vaccine product against potential contamination with adventitious agents that include bacterial endotoxins that may have been unintentionally introduced into the production and manufacturing processes.
My research team at Missouri S&T has synthesized a novel composite biofilter modified with cellulose acetate, soy protein isolates (SPI), and PolyBall nanoparticles to remove endotoxins for the purification of therapeutic protein solutions and water. The permeability, porosity, selectivity, and toxin removal were studied. The ability of endotoxin removal using PolyBall nanoparticle powder and biofilters was investigated for protein and water purification. Protein solutions and water were spiked with E. coli O111:B4 endotoxins and passed through the biofilter. The amount of
endotoxins in filtrate and retentate were measured using an EndoDye assay. To control the accuracy of the spikes, an
equal amount of endotoxins was spiked into depyrogenated water (positive control). The kinetics of endotoxin removal
efficiency were determined as a function of PolyBall loading (concentration), filter composition, pore structure, and
additional factors (pH, ionic strength, etc.). The percent endotoxin removal was measured in the filtrate and retentate
solutions. The Biofilter exhibited all around capability of targeting and removing endotoxins from vaccine solutions
without the need for any external pressure or any special equipment. The exceptional selectivity combined with high
permeability for the target compound makes an ideal mode of operation for highly selective biopharmaceutical purification membranes.