Antibody fragments have the potential to become the next important class of protein-based biotherapeutics after monoclonal antibodies (MAbs). The introduction of Capto™ L, with its protein L ligand, provides a possibility for an industrial platform purification approach for capture of this class of biomolecules. Capto L can bind a broad range of antibody fragments containing kappa light chains. Capto L is the latest member of chromatographic media (resins) in the toolbox consisting of several different products with affinity for the…

We introduce a new class of Sterile Filtration for Biopharmaceutical industry with Sartopore® Platinum. It offers exceptional total throughput, thanks to its patent-pending TwinPleat technology with 1 m2 area/10” element. At the heart of Sartopore® Platinum are PES membranes permanently hydrophilized with proprietary grafting of thermally stable polymer on to membrane surfaces. This leads to minimal wetting requirements prior to Integrity testing with < 5 L./10” preflush needed in < 1 min. They also offer low Protein Binding and low…

Ion exchange resins with increased selectivity and binding capacity are now in demand and it is imperative for chromatographers to have such resins in their repertoire. The Toyopearl GigaCap® family of resins was created to meet these demands. This poster will focus on Toyopearl GigaCap CM-650M resin as a novel high-capacity weak cation exchange resin for the purification of biomolecules. A polymethacrylic base bead, Toyopearl HW-65, was chemically modified with carboxymethyl groups in the 1000Å pores of the bead which…

Complete characterization and analysis of biopharmaceuticals includes size exclusion chromatography (SEC) to measure protein aggregates and other size variants. Current silica-based HPLC-SEC methods can be time-consuming and unreliable. New advances in packing materials and instrumentation have allowed faster and more reproducible separations to be achieved. Improvements in resolution, sensitivity and throughput will be demonstrated for sub-2 μm SEC packing materials as compared to traditional silica-based columns. The effect of pore size and particle size for the analysis of aggregates and…

While improving cell growth and viral productivity in USP, DSP may become the production bottleneck if not able to withstand changes. Such a case appears when optimizing cell culture media during the development of a viral vaccine candidate. Thirty percent expression increased was balanced by twenty percent yield loss and filters clogging during the clarification step. As a consequence, clarification sequence was not scalable anymore for the further manufacturing. The poster describes sanofi pasteur approach to overcome this issue and…