Webinars

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…

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…

HCP Analysis by ELISA and Orthogonal Methods in Vaccine and Gene Therapy Development

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…

Simplifying AAV Downstream Process and Product Characterization: A Look at Purification and Analytical Tools

This webcast features: Dr. Julia Baek, PhD, Staff Specialist, Ilaria Scarfone, PhD, MBA, Field Applications Specialist, and Chantelle Gaskin, Field Applications Specialist, Thermo Fisher The optimization of the downstream process for adeno-associated virus (AAV) production with consistent quality depends on the ability to characterize critical quality attributes affecting potency, purity, and safety of the final product. As the gene therapy field continues to push products through the clinical pipeline, an increasing need for efficient analytical tools has become evident. In…

How to Optimize Final Filling in Bioprocessing

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…