Upstream

Commercial Scale Insect Cell Culture: Opportunity and Challenges in a CHO Centric World

This webcast features: Sharyn Farnsworth, Principal Scientist and Upstream Process Development-Cell Culture Group Leader, FUJIFILM Diosynth Biotechnologies A strategy for scale up and manufacture of a recombinant protein from Insect Cell Culture (ICC) using a Baculovirus Expression Vector System (BEVS) should be mapped out during the earliest stages of process development. The challenges of recombinant protein expression using ICC/BEVS production systems are different from more commonly used expression systems such as Chinese hamster ovary (CHO) and few vendors have the…

High-Throughput IgG Titer Analysis

This webcast features: Zoe Hughes-Thomas, Head Medicine Design Automation Team, and Celal Dari, Laboratory Science Apprentice, GSK Antibodies. A key cornerstone of pharmaceuticals, from oncology to immunology. But how do we quantify them? Existing methods have proven the process needs to be improved, from long assay turnaround times to discordant results. A key method of innovating the process includes embracing new technology including automation and new assays. The presentation will introduce aspects of current methods of automation that aim to…

Simplify Analytical Development for Measuring Residual Plasmid DNA in mRNA, Gene Therapy, and Other Biologics Manufacturing

This webcast features: Tania Chakrabarty, PhD, Senior Manager, Innovation Leader, Research and Development, Pharma Analytics, Thermo Fisher Scientific Plasmids are common raw materials in the manufacturing of various biotherapeutics, from use as template for mRNA vaccines to gene introduction via transfection of mammalian cells for viral vector production. Worldwide regulatory agencies (WHO, EMA, US FDA, etc.) require that clearance of residual plasmid process-related impurities via downstream purification be demonstrated to below the accepted limit in the final drug substance. Previous…

Transient Technologies to Deliver Consistently High AAV Titers

This webcast features: Dr. Jason King, Business Development Manager, OXGENE Adenoassociated virus (AAV) is often the vector of choice for gene therapies; in fact, AAV represents around 37% of the current advanced therapies market. And when it comes to manufacturing AAV for in vivo gene therapies, developers must pursue triplicate goals of quality, quantity, and speed. Here, Dr. Jason King presents the quality, titer, and regulatory advantages of OXGENE’s AAV plasmid system. He discusses the key quality considerations of WuXi Advanced…

Bioprocess 101 – Cell Culture Media Analysis

This webcast features: Graziella Piras, Segment Marketing Director, Bioprocessing, Marketing, 908 Devices Cell culture media analysis is a critical piece of the bioprocessing puzzle. From starting material and throughout the growth cycle, cell culture media analysis gives you a clearer, fuller picture of how amino acids, vitamins, and biogenic amines impact cell health and productivity. This Ask the Expert session will outline two of the key applications of cell media analysis in the production of biologics: media quality control (QC)…

Process Intensification: Ways to Achieve Extreme Biologics Volumetric Productivity

This webcast features: Xiao Pan, Director of Process R&D, GenScript ProBio The trend of biologics titer increase brings significant cost reduction. Process intensification needs to be introduced and applied to improve the titer performance and lower the COGS. Besides fed batch, GenScript ProBio has developed process intensification solutions including high-density inoculation and intensified perfusion. Through this webinar, you will learn the following information: The scope and trend of process intensification Intensified perfusion development roadmap Case study of process intensification Just…

The Importance of Real-Time CO2 Monitoring in Cell Culture

This webcast features: Oliver Berteau, Pharmaceutical & Biotech Industry Manager, METTLER TOLEDO Process Analytics Inline dissolved CO2 (dCO2) measurement and monitoring during cell culture offers significant benefits for process control impacting productivity and quality attributes. Real-time dCO2 measurement complements routine dissolved CO2 measurements with a blood gas analyzer (BGA) during preclinical and commercial operations. Animal and insect cells are more or less sensitive to the level of dCO2 during cell culture. Toxic below and beyond specific thresholds, dCO2 is also…

The Critical Steps for Protein Therapeutic Potency Assay Development

This webcast features: Jennifer Lawson, PhD, Global Product Manager, Cell Banking and Testing, Sartorius Potency assays are an important part of the drug development process and are required throughout the lifetime of the product. The potency assay needs to correlate with the mechanism of action and provide an indication of stability. With these requirements comes a myriad of challenges in the development process, especially as therapeutics become increasingly complex. Assay development should be stepwise, starting with proof of concept and…

“Breez”ing the Way into Process Development with Perfusion Technology

This webcast features: Kevin Lee, Co-Founder, Principal Scientist, Erbi Biosystems The priority of speed to market is often at odds with issues around development resources, facility space, and infrastructure for both development and manufacturing. Continuous bioprocessing provides solutions for many of these challenges in certain applications, but to deliver on this promise we need fit-for-purpose tools and technologies to enable process development and provide reliable transfer to commercial manufacturing. The migration to continuous processes in process development is further hindered…

Automation of a Next-Generation Sequencing Method for Cell Line Species Identity

This webcast features: Dr. Christine Mitchell, Scientific Fellow, Analytical Development, WuXi Advanced Therapies As the gene and cell therapy market continues to expand, affordability and accelerated turnaround time (TAT) become increasingly important in the industry. Despite the escalating diversity of therapeutic modalities, the criticality of a robust cell bank remains a pivotal starting point for many biological products. The integrity of species identity for cell lines is a critical quality attribute for many cell and gene therapies, and with regulatory…