Viral clearance capacity by continuous Protein A chromatography step using Sequential MultiColumn Chromatography.

In response to the strong demand of biological protein therapeutics, such as monoclonal antibodies (MAbs), continuous downstream process was developed to deliver these molecules while maintaining desired product consistency and quality attributes, and providing manufacturing efficiency and flexibility. Viral safety is a critical quality attribute for biopharmaceuticals, such as MAbs. Evaluation of the viral clearance by the downstream process is a key component of risk mitigation.

Biological Safety of a Highly Purified 10% Liquid Intravenous Immunoglobulin Preparation from Human Plasma.

Background: A highly purified 10% liquid intravenous immunoglobulin, IQYMUNE, has been developed using an innovative manufacturing process including an affinity chromatography step for the removal of anti-A and anti-B hemagglutinins.

Objectives: The pathogen (viruses and prions) clearance efficacy of the manufacturing process and its robustness for critical steps were investigated.

Methods: The manufacturing process of IQYMUNE includes two dedicated complementary virus reduction steps: solvent/detergent (S/D) treatment and 20 nm nanofiltration as well as two contributing steps, namely caprylic acid fractionation and anion-exchange chromatography.