This webcast features: Jared Isaac, PhD, Sr. Scientist, Chromatography and Mass Spectrometry, Cygnus Technologies Next-generation recombinant vaccines and gene therapy products require clinical and commercial manufacturing of protein antigens or viral vectors produced using cell culture technologies. Regulatory guidelines require testing for cell substrate related impurities, media and purification additives, as well as adventitious agents throughout vaccine and gene therapy development to study the candidate’s purity, safety, and efficacy. While low levels of most impurities can be inconsequential, patient safety…

This webcast features: Andeka Ocio Velasco, Manufacturing & Process Validation Technician, Progenika Biopharma, a Grifols company; and Robert Martindale, Product Sales Manager, Masterflex EMEA, Antylia Scientific The final filling mistakes within bioprocessing are far too expensive to be allowed or tolerated. Continuous optimization is a commitment that all companies need to embrace to increase business profitability potential. Evaluating and utilizing new technologies will enable a faster methodology of process, increase the scaling up of bioprocesses, and increase the accuracy of…

This webcast features: Hilary Sherman, Senior Scientist, Corning Life Sciences Mesenchymal stem cells (MSCs) are one of the most frequently utilized cell types for cell therapy applications due to their ability to be isolated from several sources and easy adaptability to culture conditions. Bone marrow derived MSCs in particular are commonly studied due to their ease of access and achievable therapeutic dosage. While expanding MSCs to achieve these quantities, there is a risk for heterogeneity-induced quality failures during the manufacturing…

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex Fluoropolymers are the ultimate materials for use in bioprocess applications, providing increased purity, compatibility, inertness, and security for process fluids and bulk product. Bottles and vials manufactured from fluoropolymers have the added benefits of having virtually no leachables and extractables, a very wide service temperature range including performance down to liquid nitrogen temperatures, and unmatched durability, including being essentially unbreakable during use. This presentation will highlight the benefits of presterilized…