Webinars

Viral Clearance: A WuXi Advanced Therapies Perspective

This webcast features: Kathleen Kenney, Associate Director, Viral Clearance, WuXi Advanced Therapies, R. Christopher Manzari, Manager, Viral Clearance – DSP/Virus Production, WuXi Advanced Therapies. Join us for a discussion on the risk-based approach in the development of Viral Validation studies, a key testing requirement for regulatory submissions of viral vector-based therapeutics, at WuXi Advanced Therapies. In this webinar, members of the Viral Clearance Management team will cover the basics of viral clearance, study development and the general timeline. Collaboration between…

Promoter Discovery for Optimized Viral Vector Development

This webcast features: David W. Brighty, PhD, Head of Bioprocessing Research at OXGENE, WuXi Advanced Therapies. A primary determinant of gene expression is invariably the activity of the promoter upstream of the regulated gene. Viral vectors used to deliver a therapeutic transgene into target cells to treat disease are no exception. For viral vectors, the promoters used to drive transgene expression are typically constitutively active, often display little tissue-specificity, and frequently fail to express the therapeutic transgene at optimum physiological…

Addressing Purification Challenges for Complex Therapeutics with Custom Chromatography Resins

This webcast features: Laurens Sierkstra, Business Segment Leader, Bioproduction Group, Thermo Fisher Scientific. Ongoing progress in biotherapeutics development has initiated an increasing range of complex molecules entering the drug development pipeline such as novel vaccines and therapeutic proteins. This often rises challenges in the manufacturing process of these newer modalities, with downstream operations as a focus point as this part of the production process frequently represents a bottleneck. Addressing downstream challenges requires novel purification strategies for commercial manufacturing which may…

Improving Plasmid Design, Process and Manufacturing to Improve Viral Vector Yield

This webcast features: Richard Parker-Manuel, Group Leader for Plasmid Engineering and Production at OXGENE, WuXi Advanced Therapies. Successful development of cell and gene therapies requires robust, scalable manufacturing processes which generate high-quality material. There are substantial challenges associated with producing high viral yields and with navigating the regulatory environment to bring a therapeutic to market, a process which is often expensive and inefficient. Many challenges are attributable to the plasmid design and manufacturing step, where plasmids are the building blocks…

Accelerate Biologic Process Development and GMP Manufacturing Using In-Line Concentration Measurement

This webcast features: Ramsey Shanbaky, Associate Director, Bioprocess Applications, Repligen In-process measurement is the key to process monitoring and control. It can save time and money by helping you identify key aspects of your process in real-time. In this webcast, we will demonstrate how the CTech™ FlowVPX™ Slope Spectroscopy System, when directly integrated in one or more locations of a process stream, has helped reveal process characteristics that until now have been hidden due to the limitations of the most…

BioProcess Insider State of the Industry — December 2021 Panel Discussion

This webcast features: Georgia Sloboda, Managing Director, Latham BioPharm Group; John Hamer, Head of Sales & Marketing, Aseptic Filling Workcells, Cytiva; and James Taylor, PhD, Co-Founder & General Manager, Precision Nano Systems Inc. BioProcess Insider’s State of the Industry takes a deeper look into the recent business news affecting the biomanufacturing industry, picking apart the numbers and highlighting potential trends. With a panel of industry experts, editor Dan Stanton will discuss recent M&A in the bioprocess space, bottlenecks within the…

Development of an Automated AAV8 Capsid Titer Assay on Gyrolab® xPand Immunoassay Platform

This webcast features: Matthew Lotti, Senior Research Associate, Ultragenyx. The fast-growing gene therapy industry is in pressing need for fast and reliable analytical methods to accelerate bioprocess development and manufacturing of AAV viral vectors. Matt Lotti, Senior Research Associate II at Ultragenyx, a pharmaceutical company developing therapies for patients with rare genetic diseases, will present how the Analytical Development team at Ultragenyx developed a Gyrolab-based assay that demonstrates acceptable accuracy and precision for supporting in-process testing of AAV8 capsid titer.…

Modernize Your Gene Therapy Analytics with Automated Tools from Bio-Techne

This webcast features: Chris Heger, PhD, Director of Applications Science, Bio-Techne. Modern medicines call for modern technologies. Gene therapy is an exciting approach at work to cure diseases, where genetic material is delivered to a patient via a viral vector. This approach requires a doubly complex drug that contains both protein and oligonucleotides, and existing analytical tools just don’t meet the quantitative needs of these complicated therapeutic agents. In this webinar, hear how a variety of innovative analytical tools from…

Practical Approaches to Metals Analysis of Cell Culture Media & Impact on Therapeutic Protein Production Using ICP-MS

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…

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…