Downstream

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…

Lenti Non-Settled Suspension Harvest Clarification Process Development

This webcast features: Stephen Tottey, PhD, Associate Principal Scientist, Process and Technology Development, Wuxi Advanced Therapies and John Taylor, Process Development Scientist, MilliporeSigma. Clarification of non-settled Lenti suspension harvest can be challenging due to high level of impurities in the feed stream, physical characteristics of the vector, limited filter choices, and low recovery. A series of clarification studies led to the identification of two feasible clarification filter set up options that provide workable outcomes regarding product recovery, impurity reduction, process…

Manufacturing Considerations for Virus Filtration Processes Using Planova BioEX

This webcast features: Parag Patel, Senior Regional Manager, Asahi Kasei Bioprocess Viral clearance of biopharmaceutical- and plasma-derived therapeutics is an important regulatory requirement that ensures patient safety.  Although there are many viral clearance strategies and technologies that can be deployed, size exclusion filtration remains the gold standard in virus removal. Virus filtration by size exclusion is a robust method for removing virus without impacting the efficacy of the final drug product.  We will take you through the steps of developing…

A New AEX Mixed-Mode Chromatography Resin for High Selectivity and Recovery

This webcast features: Dr. Xuemei He, R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories Biomolecules are becoming more diversified and complex. Bio-Rad’s newest hydrophobic AEX chromatography resin, Nuvia aPrime 4A, is engineered with distinct balance of ligand density and hydrophobicity. In this webinar, Dr. Xuemei He will introduce the properties of Nuvia aPrime 4A Resin. This mixed-mode resin is designed to facilitate selective and reversible binding of target molecules for higher purity and recovery over traditional chromatography resins. Case studies will…

Clearing the Way for Viral Clearance

This webcast features: David Cetlin, CEO, MockV Solutions and John Li, Staff Scientist, Thermo Fisher Scientific. To determine the viral clearance efficacy of biomanufacturing steps, mammalian viruses are “spiked” into in-process solutions, processed and analysed for reduction. Due to the infectious nature of these live viruses, “spiking studies” are typically conducted in specialized BSL-2 facilities. The costs and logistics associated limit viral clearance analysis during process development and characterization. To overcome this challenge, a non-infectious Minute Virus of Mice –…