Webinars

Ensuring Viral Safety in Cell & Gene Therapy Through Next-Generation Sequencing

This webcast features: Horst Ruppach, Senior Scientific and Portfolio Director, Global Biologics, Charles River The viral contamination risk of cell and gene therapy products is significant. Multiple factors open the windows for viruses to enter the process. The current viral risk mitigation strategies have limitations and can either not be applied or have limitations to cover a broader range of potential viral contaminants. One of the most important entry points to monitor are the cells. They are used to produce…

Key Considerations for Maximizing LV and AAV Production in Transient Transfection Workflows

This webcast features: Leisha Kopp, Applications Scientist, Mirus Bio Recombinant adenoassociated virus (AAV) and lentivirus (LV) are critical components of gene and cell therapies, which show incredible promise for the treatment of disease. Accordingly, the need for large-scale manufacture of safe and effective viral vectors has never been greater. Here, we present: Optimization strategies for AAV and LV generation in both adherent and suspension HEK 293 cells LV and AAV enhancers that further increase functional virus titers over previously optimized…

“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…

Virus-Like Particle Production in Insect Cells Using the Baculovirus Expression System: Addressing Challenges across the Workflow

This webcast features: Maya Yovcheva, R&D Scientist, Cell Biology, Chantelle Gaskin, Field Applications Scientist, Purification, and Florian Durst, Sr. Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific Being part of the newer generation of vaccines, virus-like particles (VLPs) have proven to be effective in humans as well as animals. VLPs mimic the structure of the virus particles they are derived from and are highly immunogenic, but they lack the virus genomic material which gives them a favorable safety profile. The…

Manufacturing a Recombinant Retrovirus: Downstream Purification Process Development through GMP Implementation

This webcast features: Mark Fitchmun, President and CEO, Somatek, Inc. Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. In this webinar, a case study will be presented and will detail the importance of resin screening, endonuclease treatment, process development, and the scale-up purification of a retrovirus-like particle intended for use in human subjects. The resulting current good manufacturing practice (CGMP) compatible process required approximately four hours to purify 240 L of…

Increase Efficiency in Your Manufacturing With the Right Buffer Management Strategy

This webcast features: Jenny Dunker, Global Product Manager, and Alex Troken, Global Product Manager, Cytiva Buffer preparation is still a highly manual activity in the biopharmaceutical industry that often requires a lot of resources due to the large number and overall volume of buffers and process liquids used in a typical bioprocess workflow. Most companies are still relying on the traditional ways of preparing buffers, but there are more modern, alternative buffer preparation methods that can bring significant savings and…

Formulation and Characterization Strategies for Gene Therapies

This webcast features: Sarathi Vijay Boddapati, PhD, Associate Director, Formulation and Drug Product Development, Catalent Cell and Gene Therapy Formulation studies for gene therapy products are currently limited in scope and revolve around gathering stability data at frozen storage conditions. A systematic approach towards understanding degradation mechanisms followed by buffer and excipient selection is required. Catalent Cell & Gene Therapy is working towards an approach for gathering product knowledge and establishing formulation selection criteria using traditional/routine techniques that are historically…

Thermo Scientific DynaDrive SUB: Perfusion Application and Customer Experience Highlights

This webcast features: Kristin O’Neill, Principle Scientist, and William Tran, Sr. Bioprocess Engineer, Merck & Co., Inc., and Kevin Mullen, Senior Product Manager, Thermo Fisher Scientific As the demand for single-use technologies increases in terms of performance, efficiency, and ease-of-use, Thermo Fisher Scientific has introduced a next-generation bioreactor to the biopharma industry: The Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor (SUB). Building on our extensive experience, as well as nearly two decades of end-user feedback, the HyPerforma DynaDrive SUB employs a…

HCP Analysis using Mass Spectrometry: Strategies for Your Process Development Toolkit

This webcast features: Dr. Christina Morris, Senior Scientist, BioPharmaSpec Expression systems of either mammalian, yeast, or bacterial origin are commonly used as host cells for the production of biopharmaceuticals. As a consequence of using these systems, endogenous host cell proteins (HCPs) will inevitably copurify or will be coexpressed and contaminate the product material. It is a regulatory requirement to identify and monitor process-related impurities such as HCPs, and a qualitative and quantitative assessment of the components in the final drug…