Ask the Experts Archives - Page 15 of 30 - BioProcess InternationalBioProcess International

Technology-Ready Processes for Gene Therapy Manufacturing 2.0

This webcast features: René Gantier, PhD, Director of Technology, Gene Therapy, Repligen The current manufacturing processes for viral vectors for gene therapy, which we can define as Gene Therapy Manufacturing 1.0 (e.g., adherent cell culture and transient expression from plasmid transfection), are not productive enough to meet the future demand considering the quickly increasing number of approved gene therapies and clinical trials. A transition is therefore ongoing to implement more productive and scalable processes, leading to Gene Therapy Manufacturing 2.0 using…

Ask the Expert: Key Considerations for Cryogenic Preservation and T-Cell Viability

by BPI Contributor

Cryopreservation provides critical protection for cell therapies by minimizing genetic changes. But cooling too slowly or quickly risks diminishing cell viability upon thaw. On 11 March 2020, Peter Kilbride (senior research scientist) and Julie Meneghel (cryobiologist), both of Cytiva (formerly GE Healthcare Life Sciences), discussed the importance of controlled-rate cryopreservation. Illustrating how mammalian cells change when frozen, Kilbride and Meneghel offered concrete cryopreservation strategies and identified temperatures at which it is safe to stop controlled cooling and transfer drug product…

Ask the Expert: A Robust, Stable Platform for Biologics Development

by BPI Contributor

Sean Liour (vice president for project management at GenScript ProBio) delivered an Ask the Expert presentation on 18 March 2020 to explore the advantages of his company’s platform for cell-line development. Liour explained that successful biologic development hinges on robust host cell lines, capable expression vectors, and discriminating clone-screening systems. Overviewing relevant technologies and capabilities, Liour illustrated how his company’s ProCLD platform helps sponsors navigate cell-line development. Liour’s Presentation Researchers must weigh their options carefully when selecting a host cell…

Innovative Closed Process CAR-T Cell Therapy Platform to Streamline Approach for Manufacturing with Great Predictability

by BPI Contributor

This webcast features: Tatiana Golovina, Senior Director, Cell Therapy Process Development, WuXi Advanced Technologies For many years, the primary forms of cancer treatment have been chemotherapy, radiation, and surgery. An amazing breakthrough known as chimeric antigen receptor (CAR) T-cell therapy is being studied in the treatment of various types of cancer, including acute and chronic lymphoblastic leukemia, non-Hodgkin lymphoma, myeloma, and solid tumors. Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. WuXi Advanced…

Assessing Viral Clearance in Early Phase Process Development

by BPI Contributor

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…

Accelerating Vaccine Development By Innovative Purification Solutions and State of the Art Quality Testing

by BPI Contributor

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,…

World-Class AAV Vector Suspension Platform to Accelerate Commercialization to Market with Greater Predictability

by BPI Contributor

This webcast features: Juan Lagos and Steve Tottey, Associate Directors of Upstream and Downstream Process Development, WuXi Advanced Therapies Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. WuXi Advanced Therapies launched a new world-class adenoassociated virus (AAV) vector suspension platform that complements integrated capabilities enabling cell and gene therapies to be developed, manufactured, and released faster and with greater predictability globally. In this webinar, we will discuss our recent technical advancement on efficient…

Identification of Host Cell Protein (HCP) Impurities using Antibody Affinity Extraction and Mass Spectrometry Approach

by BPI Contributor

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…

Assembly, Labeling, and Packaging Trends: Next Decade’s Sterile Finished Goods Solutions

by BPI Contributor

This webcast features: Thomas Gabriel, Director, Strategy and Business Development, FUJIFILM Diosynth Biotechnologies Learn new trends in packaging, labeling, and distribution of finished goods and supporting technology platforms. At this event, there will be a presentation and dialogue regarding: patient convenience: trends, approaches and demands for future treatments medical device delivery systems of the next decade digitalization’s improvements to patient quality of life and medicinal ease of use manufacturing and supply chain networks of the future. Watch the recorded webcast…

Mixed-Mode Chromatography Resins for Biomolecule Purification

by BPI Contributor

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…