This webcast features: Van Leang, Senior Director of Global CMC Operations, HJB Bio Vendors supporting biologics manufacturing are developing equipment to enable continuous process in downstream operations. Using continuous downstream operations reduces operational time and raw material costs. HJB has developed a downstream hybrid process that uses an automated batch approach to achieve a continuous downstream capture process. This allows the use of the current monoclonal antibody (MAb) capture platform but reduces cost overall by adopting the benefits of continuous…

This webcast features: William H. Rushton, Process Chromatography Support Scientist, Bio-Rad Laboratories Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. A design of experiments (DOE) approach was utilized in this case study to investigate the effect of…

This webcast features: Sirat Sikka and Florian Durst, Field Application Scientists (Purification and Pharma Analytics), Thermo Fisher Scientific The emergence of new diseases and infections has entailed the need for rapid and efficient development of safe and efficacious vaccines. Additionally, no effective vaccines currently exist for long-known pandemic diseases such as HIV or malaria. To address the challenges the vaccine industry faces, new vaccine modalities such as viral vectors, recombinant protein subunits, and nucleic acids are being researched and developed,…

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…

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…

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…

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…

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…

This webcast features: Dr. Koen Sandra, Scientific Director, Research Institute for Chromatography, and Geert Van Raemdonck, Global Field Support Expert, PharmaFluidics 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…