Ask the Experts

Improve Productivity and Operational Efficiency with Single-Use Technology

This webcast features: Rob Martindale, Product Manager, EMEA, Masterflex In many manufacturing environments, and especially in the biopharmaceutical market, there is a constant emphasis on making productivity improvements and streamlining every-day processes. One solution that many companies are turning to is the implementation of single-use technology. In this webinar, we will expand on what’s possible with single-use technology and then highlight practical ways single-use technology can make positive impacts on your workflow and on your bottom line. Just fill out…

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…

rEVolutionizing Acellular Therapies with Corning HYPER Technology

This webcast features: Amy C. Kauffman, PhD, Senior Development Engineer, Corning Life Sciences Extracellular vesicles (EVs) are a population of particles that are naturally released from cells. They are involved in intercellular communication, providing the necessary factors to mediate physiological events, and they are of high interest because of their potential for becoming the next generation of therapeutics. One potential area of interest is in generating an EV therapeutic in place of mesenchymal stem cell (MSC) therapies for pathological conditions…

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)…

The Way Forward in Therapeutic Antibody Purification

This webcast features: Dr. Anna Le Bris, Senior Application Specialist and Trainer, Thermo Fisher The development of therapeutic antibodies has made an enormous progression in the last decades. Antibodies have become the predominant class of biological drugs and are used to treat a variety of diseases such as cancer. Recently, neutralizing antibodies to halt infectious diseases are entering the clinical pipeline, including against Sars-Cov2. Affinity purification platforms such as Protein A or L are well established in the manufacturing process…

Exploring On-Column mAb Aggregate Formation and Self-Generated On-Column pH Gradients with Cation Exchange Resins

This webcast features: William H. Rushton, Process Chromatography Support Scientist, Bio-Rad Laboratories The formation of aggregates is a common occurrence during monoclonal antibody (mAb) purification and can happen for several reasons. Aggregates are undesirable due to the possibility of altered pharmacodynamics, pharmacokinetics, and/or increased immunogenicity. Generally, the formation of aggregates is shown to be product or process related. A high-resolution cation exchange (CEX) resin, Nuvia HR-S, has been shown to reduce aggregate content with high monomer recovery. In this webcast,…

Scalable Lentiviral Vector Manufacturing Using Proprietary Suspension Cell Line

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…

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 Path Toward Successful Innovation in Gene Therapies

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…