Downstream

Identification of Host Cell Protein (HCP) Impurities using Antibody Affinity Extraction and Mass Spectrometry Approach

This webcast features: Eric Bishop, Vice President of Research & Development, Cygnus Technologies A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Unfortunately, the ELISA does not inform which HCPs are present or to which HCPs the assay reacts. Mass Spectrometry (MS) is a powerful tool for identifying those HCPs that persist through downstream purification…

Mixed-Mode Chromatography Resins​ for Biomolecule Purification

This webcast features: Dr. Xuemei He, R&D Chromatography Media Chemistry Manager, Bio-Rad Laboratories Mixed-mode chromatography has emerged as a viable purification method for biomolecules that are otherwise difficult to purify using traditional chromatography platforms and other established means. Scientists are gaining an increased understanding of mixed-mode mechanisms and how these interactions impact selectivity. The industry is becoming more adept at including mixed-mode steps in production processes while also working to address robustness, platform fit, and productivity. This webinar will examine…

Closed, Single-Use TFF Assembly Makes Performance-Leading TangenX Cassette Technologies Even Easier to Use

This webcast features: Michael LaBreck, Global Bioprocess Sales Specialist, TangenX™ TFF Products, Repligen Corporation SIUS-Gamma TFF cassettes incorporate the performance-leading TangenX™ TFF membrane and cassette manufacturing technologies into a closed, gamma-irradiated, single-use assembly. Genderless, aseptic connections easily integrate into your current UF/DF flow path, and a library of 64 MWCO and surface area configurations provide rich process options. The closed format, leading TFF performance (flux, selectivity, reproducibility) of the TangenX membrane and manufacturing innovations that enabled the first single-use by…

Asahi Kasei Bioprocess’ Planova SU-VFC: Realizing Single-Use Technology in Virus Filtration

This webcast features: Brian Crawford, Director of Operations, Asahi Kasei Bioprocess America, Inc. By eliminating the need for clean-in-place, reducing demands on quality control, and optimizing product changeover times, single-use systems offer great benefit at pilot, clinical, and commercial production scales. The new Planova™ Single-Use Virus Filtration Controller (SU-VFC) from Asahi Kasei Bioprocess America, Inc. offers the hallmark consistency of Planova™ filters in a compact, fully automated single-use form factor with full 21 CFR Part 11 compliance for greater efficiency…

Efficient Solutions for the Purification of Challenging Antibody Formats

This webcast features: Laurens Sierkstra, Senior Director, Business Leader, Purification, Thermo Fisher Scientific Inc., Bioproduction Leiden/Naarden, The Netherlands The changing landscape for antibody-derived therapeutics, such as bispecific monoclonal antibodies, Fab fragments, and Fc-fusion proteins brings new purification challenges in the downstream process of these molecules. Standard chromatography resins, such as Protein A, may not result in the most efficient process. Thermo Scientific™ CaptureSelect™ resins, focusing on alternative antibody domains, enhance the success of your antibody purification process. From research to…

Highly Sensitive Host Cell Protein Analysis Using µPAC™ LC-MS

This webcast features: Dr. Koen Sandra, Scientific Director, Research Institute for Chromatography Within a rapidly growing biopharmaceutical market, there is an increasing demand for the development of a rising number of biotherapeutic protein drugs, such as monoclonal antibodies (MAbs). During the development and production of biotherapeutic proteins, typically using mammalian cell lines, such as Chinese hamster ovary (CHO) cells, additional proteins are expressed as well by the host cell. These so-called host cell proteins (HCPs) will need to be removed,…

Investigation of Hitchhiking Impurities Removed by the 3M EMPHAZE AEX Hybrid Purifier

This webcast is hosted by: Dr. Hani El-Sabbahy, Biopharmaceutical Application Engineering Specialist, Separation and Purification Sciences Division, 3M United Kingdom PLC 3M™ Emphaze™ AEX Hybrid Purifier is an all-synthetic clarifier consisting of a high capacity Q-functional hydrogel and a 0.2 μm polyamide membrane. The open structure and high charge capacity can handle turbid feeds, resulting in soluble and insoluble contaminant removal. Using data generated by sophisticated LC-MS/MS techniques, this webinar will explore the impact of deploying the Emphaze AEX Hybrid…

Packing Rigid POROS Chromatography Resins: Efficient and Fast Method to Get Optimal Results

This webcast features: Dr. Anna Le Bris, Senior Application Specialist, Bioproduction, Thermo Fisher Scientific POROS resins are widely used in commercial bioprocesses for the purification of large molecules, in both the capture and polish steps of downstream processing. POROS chromatography resins are based on a rigid polymer, allowing them to withstand very high pressure and be mechanically and chemically stable. Because POROS is a rigid bead, it can be packed in cGMP columns with volumes up to 1000 L. POROS…

Robust Performance of OPUS® Columns Pre-Packed with CHT™ Resin

This webcast features: Fletcher Malcom, Product Line Leader – Chromatography, Repligen Ceramic hydroxyapatite (CHT™) resins are used in processes where unique selectivity is desired for purification of mAbs or recombinant proteins. Until recently, shipping columns pre-packed with CHT™ resin provided challenges due to the fragile nature of the chromatographic bed. To overcome these challenges, Repligen has developed a proprietary packing method for CHT™ resins which maintains chromatographic performance during transit. In this presentation, packing performance and shipping validation data will…

Scalable Purification Strategies for Viral Vectors and Vaccines

This webcast features: Mark A. Snyder, Ph.D., R&D Manager, Process Chromatography Applications, Bio-Rad Laboratories Large-scale downstream processing of viruses can face a range of obstacles different from those of many biotherapeutics. These challenges mostly arise from the size and complexity of the virus, which can affect product purity and recovery. Improvements of purification tools are necessary to overcome these challenges and must be engineered for easy scalability to meet manufacturing demands. Dr. Mark Snyder will discuss the difficulties when developing…