This webcast features: Andrew Lowell, Associate Director, Upstream Process Development, KBI Biopharma, Inc. KBI Biopharma, Inc. has implemented single-use fermentation (SUF) systems that have allowed greater throughput and efficiency in the laboratory, leading to accelerated project timelines to good manufacturing practice (GMP) production. The single-use fermentation systems address those programs with relatively small material needs while decreasing validation requirements and increasing operational efficiencies. Coupling process design with the SUF equipment capabilities has enabled processes capable of high cell densities and…
Ask the Experts
Accelerating Development and Manufacturing Platforms for Viral Vectors
This webcast features: Bai-wei Gu, Head of the Cell Line Development Group, WuXi Advanced Therapies Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. In this webinar, we will discuss our recent technical advancements in efficient viral vector manufacturing process development. From cell line development, to suspension culture of HEK293 cells, to media optimization and purification process, a series of improvements were implemented to advance our platform development for scalable large-scale manufacturing of viral…
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…
Bioprocessing Challenges and CMO Opportunities in China
This webcast features: Scott Wheelwright, PhD, Co-Founder and Principal, Complya Asia China’s biopharmaceutical manufacturing is significantly increasing, among domestic and international companies. Contract manufacturing services as well as those with potential to do so are rapidly changing as well. In Part 4 of our series, Dr. Scott Wheelwright, Co-Founder and Principal, Complya Asia, will provide an overview of factors affecting manufacturing, manufacturing trends by market, biopharmaceutical manufacturing in China among CMOs and developing companies. Watch the recorded webcast below.
Systems Compliance: A Risk-Based Approach to Software Management
This webcast features: Martin Laferriere, Director, IT Systems Compliance, Avid Bioservices Software systems risk management and evaluations should be part of your validation process. It is possible to reduce testing by documenting your risk, actual use, regulation impact, evaluating vendor(s), etc. The approach to managing the risk evolves through audits and prior experience and can tailor the management and approach to system quality within each organizations. In my experience and observations, an efficient system risk management is essential, and it…
Ask the Expert: Clarification of Lentiviral Vectors Using Scalable Filtration
Researchers traditionally have produced lentivirus (LV) in adherent cultures by transient transfection using media containing animal serum. The method is inexpensive for process development (PD) and early clinical trials, but it requires increased operator manipulations and costs during scale-up. Development scientist Adam McLeod delivered an Ask the Expert webinar on 27 August 2019 to illustrate how GE Healthcare Life Sciences at the Centre for Advanced Therapeutic Cell Technologies (CATCT) in Toronto, Canada, approaches lentiviral vector (LVV) manufacturing. McLeod explained that…
Ask the Expert: Automated, Closed-Loop, Inline Monitoring of CAR T Cells in a Production Process
Jan Van Hauwermeiren (vice president of sales and marketing at Ovizio Imaging Systems) joined BPI for an Ask the Expert webinar on 29 August 2019. He demonstrated how his company’s iLine F microscopy system combines sensitive optical capability with machine learning to monitor chimeric antigen receptor (CAR) T-cell expansion, transduction, and activation. The device captures holographic images of cells as they pass through a single-use conduit running between a microscope and bioreactor. Cells then funnel back into culture without additional…
Using Slope Spectroscopy for Faster, Repeatable, More Accurate Protein Concentration Measurements
This webcast features: Joe Ferraiolo, Bioanalytics Applications Manager, Repligen Traditional capture chromatography titer measurements that involve dilution requirements represent the highest single source of error in traditional UV analysis. Slope spectroscopy requires no sample preparation or dilution, saving substantial time without changing any other aspects of the assay. This webinar will demonstrate how variable pathlength slope spectroscopy using the SoloVPE™ device can significantly reduce sample prep and process time, while maintaining high repeatability and accuracy. Watch the recorded webcast below.
Highly Sensitive Host Cell Protein Analysis Using µPAC™ LC-MS
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…
Cell Culture Media Analysis Using a Handheld Raman Analyzer with Onboard Chemometrics
This webcast features: Orville Dean Stuart, Technical Regional Sales Manager, Thermo Fisher Scientific This webinar presents the use of a handheld Raman analyzer with onboard chemometrics to verify the identify and monitor the quality and batch-to-batch variability of both dry powder chemically defined media and ready-to use liquid cell culture media. While scans of cell culture media using Thermo Scientific’s TruScan RM handheld Raman analyzer produce spectra with good Raman features, due to similar constituents and formulations, the TruTools add-on…