Affinity chromatography resins employ target-specific ligands attached to a stationary phase and are commonly used to capture therapeutic entities in biologics manufacturing, reducing the number of required purification steps and increasing overall yield. A less common but powerful use of affinity purification is the removal of problematic impurities, such as host cell proteins. Both techniques require high-specificity affinity ligands with sufficient capacity, stability, and suitability for clinical manufacturing. In this webinar, we present the development of a novel scavenging resin…

This webcast features: Jared Isaac, PhD, Associate Director, Chromatography and Mass Spectrometry, Cygnus Technologies. In recent years, we have learned that host cell proteins (HCP) can cause problems with respect to patient safety, drug substance (DS) stability, and DS efficacy. As such, it is more important than ever to fully understand the HCPs in your process. This webcast will focus on using advanced methods of immunoaffinity chromatography and mass spectrometry to fully characterize the host cell protein ELISA as well…

This webcast features: Artur Stanczak, Application Specialist, Process Chromatography, Bio-Rad Laboratories. A monoclonal antibody (MAb) purification process involves multiple consecutive steps, typically using three chromatography resins. These three purification steps are referred to as capture, intermediate, and polish. The workflow is based on multiple criteria to maximize product quality and output, including process efficiencies. One focus area of process intensification is reducing the downstream processing (DSP) steps to improve the MAb purification workflow. Mixed-mode resins are being increasingly integrated into…

This webcast features: Jessica Waller, PhD, Principal Scientist Biologics Development, Bristol Myers Squibb. Bispecific antibody configurations with multi-targeting capabilities are evolving as new generation biologic therapeutics with potential for enhanced efficacy and reduced toxicity. Significant challenges arise with downstream purification of these molecules due to a unique panel of product-related variants or mispaired species that must be monitored and cleared in product pools. Viral clearance capability is another critical component when developing a downstream process, as mammalian CHO-derived products have…

This webcast features: Thomas Valorose, Senior Product Manager, Astrea Bioseparations. Despite considerable advances in downstream purification for MAbs and other recombinant proteins from various expression systems, there remains a need for effective removal of process and product related impurities that could impact product safety, stability, and efficacy. Many workflows today utilize multiple steps to polish their product, including ion exchange and hydrophobic interactions. Utilizing mixed-mode purification techniques, Astrea Bioseparations delivers a solution that has several advantages over traditional workflows. By…

This webcast features: Manuel Matos, PhD, Field Application Scientist, Thermo Fisher Scientific and Marco Baldazzi, DSP Research Laboratory Technician, Menarini Biotech. While protein A affinity chromatography is the most commonly used method for monoclonal antibody (MAb) capture in clarified harvest coming from CHO cell cultivation, one significant challenge is the high cost of the media required when using these resins. Therefore, it’s crucial to evaluate alternative strategies that may reduce costs and increase productivity without affecting product quality attributes. In…