Webinars

Continuity of Methods: Characterizing Protein Therapeutic Stability From Developability Assessment to Release With Aura PTx

This webcast features: Bernardo Cordovez, CSO, Co-Founder, Halo Labs. Aura PTx is a complete protein therapeutic stability solution that enables characterization of subvisible particle aggregates from developability assessment through product release. Aura PTx is a high throughput analytical instrument that images, counts, sizes, and identifies subvisible particle aggregates, a critical quality attribute and the most important biologic stability parameter. Using volumes as low as 10 µL and with measurements of one minute per sample, Aura PTx enables rapid, highly contrast and…

Sustaining Project Management Business Continuity and Partnerships Throughout COVID

This webcast features: Patrick Haley, Sr. Director, Project Management & Business Operations, Avid Bioservices, Inc. The Avid project management office employed unique technology and communication techniques to maintain business continuity and material supply to our partners and the patients they serve throughout each COVID surge. This presentation will take a deep dive into the challenges and solutions encountered for each functional area in the biologics development and production process during the early COVID pandemic and later surges, while ultimately discussing…

Increasing Productivity of IVT Reaction Using At-Line Monitoring by HPLC Chromatography

This webcast features: Rok Sekirnik, PhD, Head of Process Development mRNA/pDNA, BIA Separations, now a Sartorius company. In Vitro Transcription (IVT) reactions are normally performed as batch processes. Considering their catalytic basis, it is possible to extend reaction times and yields by continuous addition of consumed reagents to the reaction mixture. However, fed-batch strategies reported to date have only managed to achieve a 40 – 100% increase in the production of mRNA. One of the main limitations of development has…

Improve Your Cell Line Development Workflows with Analytical Tools

This webcast features: Dirk Müller, PhD, Manager of Media & Process Development, Sartorius, Lukas Klein, Scientist, Sartorius. Cell line development involves screening thousands of clones to find those that are stable, produce high yields of the bioproduct, and exhibit desired critical quality attributes (CQAs). While there are multiple CQAs that need to be monitored early in the development process, product yield, cell count and viability assessment remain the main attributes by which process conditions are optimized. Incorporating analytical techniques into…

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…