Increasing demand for monoclonal antibodies (MAbs) as biopharmaceuticals has promoted the development of cell cultures with very high expression levels. Over the last 20 years, the antibody titers of mammalian cell culture have risen dramatically. Today, we commonly see titers of 5 to 10 g/l, and expression levels as high as 15 g/l or greater have been reported. The demand for purification processes that can handle this increase has risen accordingly.
The large-scale purification of MAbs usually consists of two or three chromatographic steps, and protein A affinity media are often the first choice for initial capture because they deliver high purity (> 99%) and yield in a single step. Protein A affinity chromatography also requires minimum conditioning prior to loading and allows rapid transfer to a stable process intermediate.
The MabSelect™ family of affinity chromatography media, which is based on the protein A ligand, has found wide acceptance among large-scale commercial manufacturers of biopharmaceutical MAbs. This media family has expanded to meet the developing needs of large-scale manufacture. A recent addition is MabSelect SuRe LX, which is based on the same rigid high-flow agarose matrix and alkali-stabilized ligand as MabSelect SuRe. This ligand withstands rigorous CIP and sanitization procedures with 0.1 or 0.5 M sodium hydroxide (NaOH). Compared with MabSelect SuRe, however, MabSelect SuRe LX offers 20% to 50% higher dynamic binding capacity at slightly longer residence times (e.g., 6 to 10 min).
Lifetime performance study of MabSelect SuRe™ LX during repeated cleaning-in-place
One study aimed to quantitate the long-term chromatographic performance of MabSelect SuRe LX during repeated purification cycles that use 0.1 or 0.5 M NaOH for cleaning-in-place (CIP). Parameters measured included dynamic binding capacity, yield of antibody, and levels of leached protein A and host cell proteins (HCP). See the full text of the application note here: Lifetime performance study of MabSelect SuRe™ LX during repeated cleaning-in-place
Dynamic binding capacity study on MabSelect SuRe™ LX for capturing high-titer monoclonal antibodies In another study, the dynamic binding capacity (DBC) of MabSelect SuRe LX, an alkali-stabilized, protein A-derived affinity medium (resin) for capturing monoclonal antibodies (MAbs), was measured at different residence times and feed concentrations. DBC increased with increased residence time, while MAb concentration did not have any significant influence. MabSelect SuRe LX and MabSelect SuRe DBC were also compared for seven different MAb-containing feedstocks. At longer residence times, MabSelect SuRe LX displayed 20% to 46% higher DBC. The productivity of both was also analyzed. Results suggest that over its lifetime, MabSelect SuRe LX could purify up to 50% more antibody than MabSelect SuRe. See the full text of the application note here: Dynamic binding capacity study on MabSelect SuRe™ LX for capturing high-titer monoclonal antibodies