Improving viral filtration capacity in biomanufacturing processes using aggregate binding properties of polyamide-6,6

Area of Science:

• Biopharmaceutical Manufacturing
• Filtration Technology
• Protein Aggregation

Background:

• Virus retention filtration is crucial for biopharmaceutical safety, removing viruses via size exclusion.
• Modern parvovirus filters offer improved performance but face challenges with premature fouling.
• Process optimization for viral filtration capacity can be demanding.

Purpose of the Study:

• To investigate the use of polyamide-6,6 (nylon-6,6) membranes as prefilters to enhance parvovirus retentive filter capacity.
• To elucidate the mechanism behind polyamide-mediated filtration improvement.
• To assess the potential of polyamide-6,6 as a cost-effective solution for viral filtration.

Main Methods:

• Utilized polyamide-6,6 membranes as prefilters in conjunction with parvovirus retentive filters.
• Investigated the binding of monoclonal antibody (mAb) aggregates to the prefilters.
• Employed mobile phase screening, additive spiking, and molecular dynamics simulations.
• Analyzed the mechanism of mAb aggregate removal by polyamide-6,6 membranes.

Main Results:

• Polyamide-6,6 prefilters significantly increased the capacity of parvovirus retentive filters.
• The filtration improvement mechanism involves the binding of 20-100 nm monoclonal antibody aggregates.
• Polyamide-6,6 membranes remove mAb aggregates through hydrophobic interactions.
• This aggregate-mediated mechanism is applicable to other adsorptive prefilters.

Conclusions:

• Polyamide-6,6 membranes serve as effective prefilters, mitigating premature fouling of viral filters.
• The binding of mAb aggregates is a key factor in flux decay during viral filtration.
• Polyamide-6,6 offers a complementary and cost-effective option to extend viral filter capacity.