Protein A chromatography resins are widely used for therapeutic antibody production because they perform well, giving excellent recovery and purity. But resin-based chromatography methods are better suited to large-scale manufacture. In clinical monoclonal antibody (mAb) purification, batch sizes are small, so protein A resins are rarely used to their full lifetime potential. As a result, protein A resins may be cost-prohibitive, especially for mAb manufacturing when doses are very low or where target patient populations are small. Protein A resins…

This webinar provides a virtual demonstration of the BioSMB multi-column chromatography platform — a fully scalable single-use solution that reduces resin usage and enables manufacturers to explore continuous processing. The demo starts with an overview of the BioSMB PD system for small-scale manufacturing and then continues with the BioSMB Process systems for clinical and commercial manufacturing. Click here to watch this virtual demonstration.

This overview highlights a few examples from drug discovery and process development where the Octet® system demonstrated a significant reduction in the analysis time over ELISA and HPLC by eliminating the need for purification, while still achieving high accuracy and precision. The total assay times were dramatically reduced with fewer assay steps and less labor time involved. The easy and versatile, fully integrated Octet® assay has additional advantages over other label-free technologies like SPR, where sample washing steps are required.…

Structure is an important characteristic for protein activity and function. Structural alterations due to protein mis-folding, denaturation or unfavorable conditions can lead to the formation of aggregate species that can affect the efficacy and safety of biologic drug candidates. While many biophysical analytical tools are well suited for detecting these aggregates, few offer a combination of structural and functions assessment in the same system. Sartorius’ Octet® platform is an easy-to-use analytical tool that can detect the presence of aggregated species…

Host cell proteins (HCP) are critical to quality control in biologics development. If left unremoved, they can cause immunogenic responses and reduce drug efficacy. In our last webinar we shared Cytiva’s strategy for designing a comprehensive HCP risk mitigation strategy. We discussed how to challenge your assays early to ensure accurate measurements, build confidence, and reduce the risk of unexpected HCP levels. Our HCP experts highlighted and responded to the most common questions raised around host cell protein assays. Want…