EFFECTIVE REMOVAL OF mAb AGGREGATE USING Ca++Pure-HA^® MEDIA WITH POTASSIUM SALTS

Introduction

Downstream process chromatography scientists are constantly seeking for better and more selective ways to remove aggregates and other process related impurities from a monoclonal antibody (mAb) monomer. Making use of chromatography resins with better selectivity, resolution and capacity is one approach to solving the problem of aggregate removal in monoclonal antibody production.

Ca++Pure-HA (hydroxyapatite: Ca (PO4) (OH)) is a form of calcium phosphate used in the chromatographic separation of biomolecules. Unlike other resins available from Tosoh Bioscience, Ca++Pure-HA is both the ligand and the base bead. Hydroxyapatite has unique separation properties for biomolecules and Ca++Pure-HA offers unparalleled selectivity and resolution for process scale operations. Its highly selective nature often separates proteins otherwise shown to be homogeneous by electrophoresis and other chromatographic techniques.

Ca++Pure-HA is a spherical, macroporous form of the hexagonal crystalline structure of hydroxyapatite. It has been sintered at high temperatures for increased mechanical and chemical stability, allowing it to withstand the rigors of industrial-scale applications. Table 1 lists the properties of Ca++Pure-HA.