This webcast features: Xiao Pan, Director of Process R&D, GenScript ProBio Fueled by recent successes of marked cell therapy products, the demand for high-quality and large-amount lentiviral vectors is also becoming greater. However, producing lentiviral vectors in an adherent system has many limitations, mainly around scalability and serum dependence. To overcome these difficulties, there is an urgent need for stable and scalable lentiviral vector manufacturing using a suspension system. GenScript ProBio is dedicated to developing lentiviral vector platforms using our proprietary…

This webcast features: Roland W. Herzog, PhD, Professor of Pediatrics, Riley Children’s Foundation Professor of Immunology, and Director of the Gene and Cell Therapy Program, Indiana University School of Medicine, and Nagendra Venkata Chemuturi, PhD, Scientific Director Research, Global DMPK, Takeda Pharmaceutical Company Gene therapies based on adenoassociated virus (AAV) vectors are emerging as a promising treatment strategy for various diseases, including an inherited form of blindness and spinal muscular atrophy. A major obstacle for the wide use of gene…

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…

This webcast features: Jigisha Patel, VP of Regulatory Compliance & Technical Services, Spectrum Chemical Mfg. Corp. What can go wrong will go wrong—unless you eliminate unpredictability that results in reworks, rising costs, nonconformance, and unreliable product performance. Learn how to implement quality management systems throughout your entire supply chain and help accelerate biopharmaceutical development and production time for first-mover advantages. Whether it’s upstream or downstream processing, you will gain new insight that enables you to eliminate unpredictability and batch-to-batch variability…

This webcast features: Leisha Kopp, Applications Scientist, Mirus Bio Recombinant adenoassociated virus (AAV) and lentivirus (LV) are critical components of gene and cell therapies, which show incredible promise for the treatment of disease. Accordingly, the need for large-scale manufacture of safe and effective viral vectors has never been greater. Here, we present: Optimization strategies for AAV and LV generation in both adherent and suspension HEK 293 cells LV and AAV enhancers that further increase functional virus titers over previously optimized…

This webcast features: Sarathi Vijay Boddapati, PhD, Associate Director, Formulation and Drug Product Development, Catalent Cell and Gene Therapy Formulation studies for gene therapy products are currently limited in scope and revolve around gathering stability data at frozen storage conditions. A systematic approach towards understanding degradation mechanisms followed by buffer and excipient selection is required. Catalent Cell & Gene Therapy is working towards an approach for gathering product knowledge and establishing formulation selection criteria using traditional/routine techniques that are historically…

This webcast features: Dr. Shuyuan Yao, Chief Scientific Officer and Head of Research & Technology Development, WuXi Advanced Therapies In recent years, the demand for cell and gene therapy has increased substantially. The success in gene and cell therapy has also increased demand for plasmid DNA. In supplying the industry with high-quality plasmid DNA, key prominent market challenges are capacity availability, accelerated turnaround time (TAT), and affordability. In this presentation, WuXi Advanced Therapies will showcase how to address these prominent…