Webinars

Innovation of Novel Purification Strategies – A Case Study of a Clusterin Scavenger Resin

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…

Advanced Orthogonal Methods to Fully Characterize Process Host Cell Proteins

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…

ELEVECTATM — Truly Stable and Inducible Producer Cell Line for Large Scale AAV Manufacturing

The gene therapy industry has predominantly focused on rare diseases, but recently there has been a shift to prevalent diseases covering a much broader patient population. This is largely in hopes to drive down the cost of therapy as well as minimize the financial risks to therapy developers. With the current clinical trials pipeline being dominated by therapies for larger populations, the industry must recognize that our current manufacturing methods cannot efficiently produce the amount of material needed to treat…

Advances in Bioanalytical Tools for the Characterization of In-Process Viral Samples

This webcast features: Sofia B. Carvalho, PhD, Senior Research Associate, iBET. The expanding landscape of viruses and virus-like particles (VLPs) holds great promise for the development of safe and effective vaccines for a wide range of diseases. To keep up with the bioprocess progress requirements and growing regulatory constraints, it is critical to improve high-throughput in-process product quality control and vaccine manufacturing monitoring. There is a current need for novel and robust analytical tools in this area. iBET has a…

MAb Purification Process Development Using Mixed-Mode Resins — The DOE Approach

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…

New Generation Planova™ S20N Demonstrates Robust Performance for Multi-Specific Antibodies

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…

Advantages of Mixed-Mode Chromatography in Host Cell Protein Removal

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…

Accelerating Antibody Characterization and AAV Analytics Using Next Gen Biolayer Interferometry (BLI)

This webcast features: Benjamin Osborne, PhD, Senior Application Scientist, Gator Bio. Efficient kinetics and epitope binning studies are critical to biotherapeutics development. Biolayer Interferometry (BLI) is an exceptional tool to easily and quickly obtain results. In the face of modern throughput challenges, BLI instruments were historically modified to monitor multiple wells per spectrometer, resulting in poor kinetics measurements. To address these shortcomings, Gator Bio has launched the Gator Pro that enables 32 high frequency parallel measurements, alongside a family of…

Beyond Standard Protein A Resin: Establishment of an Improved DSP Affinity Platform Step for Monoclonal Antibodies

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…

Enabling Faster Feed Strategy Optimization with Rapid Spent Media Analysis and Data Visualization Tools

This webcast features: Milla Neffling, PhD, Bioprocessing Market Segment Manager, 908 Devices. Optimization of feed strategy to boost process productivity and meet critical quality attributes can greatly benefit from using real-time analytics to gain key insights into the process. Frequent measurements of key nutrients and metabolites in spent media also come with the challenge of generating daunting amounts of data. Bioprocess data visualization can therefore be a cumbersome and lengthy task when multiple dynamic key factors are considered. We highlight…