This webcast features: Dr. Adil Mohammad, Staff Fellow, US FDA, Dr. Chikkathur Madhavarao, Biologist, US FDA, Robert Thomas, CSci, CChem, FRSC, Principal Consultant, Scientific Solutions Biotechnology products (biologics) are often produced from mammalian cells grown in large-scale bioreactors. The dynamic environment within the bioreactor is comprised of growth media along with cells, proteins, nutrients of organic and inorganic origin, metabolic waste products and metal ions. Metal ions can act as enzyme cofactors and can directly influence the kinetics of biochemical…
Webinars
Adenovirus Vector Manufacturing Platform Using CIMmultus QA
This webcast features: Hana Jug, Project Manager in Process Development for Viral Vectors and Vaccines, BIA Separations Downstream processing remains one of the main bottlenecks in Adenoviral vector manufacturing. At BIA Separations, a Sartorius company, we offer a platform for purification of Adenoviral vaccines using market leading CIM® monolithic chromatographic columns and an analytical toolbox for process monitoring in Adenoviral vaccine production. Simplified purification of Adenovirus consists of typical downstream steps, including combined lysis, clarification, TFF and a chromatographic capture…
Optimization of an Anion Exchange Method for the Large-Scale Production of Plasmid DNA for Gene Therapy and DNA Vaccine Applications
This webcast features: Jenny England, Staff Scientist, Innovation & Applications, Thermo Fisher The advancement of gene therapy and plasmid DNA (pDNA) vaccines has highlighted the need for the development of a large-scale purification process to produce high purity plasmid DNA. Plasmid DNA serves as a foundation to produce viral vectors such as adenoassociated virus (AAV) or lentivirus (LV), a template for mRNA production during the in vitro transcription reaction and can be used directly as a pDNA vaccine. The typical…
Analytical Ultracentrifugation for Profiling AAV Gene Therapies: Where Are We Now?
This webcast features: Yijun Huang, Scientific Fellow, WuXi Advanced Therapies Adenoassociated virus (AAV) is often the vector of choice for gene therapies due to their low immunogenicity, ability to promote long-term gene expression, and capsid tropism-dependent tissue specificity. Representing around 37% of the current advanced therapies market, there is an ongoing demand for robust quality lot release programs capable of supporting the large patient cohorts involved in clinical trials. Along with critical quality attributes such as titer, identity, and potency,…
Container Closure Integrity: Testing of Bottles Used for Cell Therapy Applications
This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex Container integrity is critical when storing and shipping cell therapy products to ensure sterility. The security and durability of the container sealing region(s) should be weighed against usability of the container in clinical settings common to cell therapies. A study was performed to evaluate and quantitatively measure the associated leak rate for the container closure integrity of fluoropolymer bottles per USP <1207> Package Integrity Evaluation – Sterile Products using helium…
Optimized Expression Systems for Increased Productivity in CHO DG44 Based Cell Line Development
This webcast features: Dr. Rathangadhara Nammalwar, Team Lead, Cell Line Development for Protein-Based Therapeutics, Sartorius The Global Cell Line Development (CLD) services market is growing at an unprecedented pace. In 2020, the global revenues were about $700 million and are estimated to reach nearly $1.7 billion by 2028. Chinese hamster ovary (CHO) cells have been the most preferred host cell line for those CLD services, and they alone generated more than 50% of the global revenue in 2020. Key success…
Efficient and Scalable GMP Manufacture of AAV and LV with TransIT-VirusGEN® Reagent and Enhancers
This webcast features: Leisha Kopp, Applications Scientist, Mirus Bio Recombinant adenoassociated virus (AAV) and lentivirus (LV) are essential components of many gene and cell therapies designed to treat and potentially cure a vast array of acquired and heritable diseases. Thus, the need for large-scale manufacture of safe and effective viral vectors for the development of biotherapeutics has never been greater. In this webinar, we will examine critical optimization strategies that lead to simplified, defined workflows and enable higher AAV and…
Cell Media Analysis: A Critical Piece of the Bioprocessing Puzzle
This webcast features: Graziella Piras, Bioprocess Segment Director, 908 Devices Cell culture medium remains a key component of traditional monoclonal antibody (mAb)-based biologics as well as newer modalities such as gene and cell therapies manufacturing. As such, cell culture media development and optimization continue to be an important focus for the biopharmaceutical industry. Increased analytical capabilities have provided new insights into the relationship between cell culture media, the cells they support, and ultimately the outcome of the final product. That greater insight offers more…
Scaling and Stirring: Success Factors in Scale Up with Single-Use Benchtop Bioreactors
This webcast features: Cristina Bernal Martinez, Applications & Support Engineer, and Ann D’Ambruoso, Manager, Product Applications and Marketing, Getinge Single-use systems allow for a faster and easier workflow while simultaneously reducing the risk of errors and contamination in the development process. Nonetheless, fundamental bioreactor principles must be understood to correctly scale up in single-use bioreactors. Learn about the design factors in Applikon’s single-use bioreactors and review common scale-up strategies based on tip speed, power input, and kLa. Furthermore, shear stress…
Manufacturing Capacity and Supply Chain Resilience
This webcast features: Ari Ojinaka, Production Manager, Astrea Bioseparations With increasing demand for vaccines and advanced therapeutic treatments, innovation and resilience are critical to stay ahead of the quickly shifting needs of the industry. As demand for bioseparation products continues to increase and evolve to accommodate traditional and advanced drug profiles, suppliers must ensure that they are delivering more than just products to customers. It is essential to evaluate effective ways to manage and increase capacity and supply chain resilience…