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Efficient and Scalable GMP Manufacture of AAV and LV with TransIT-VirusGEN® Reagent and Enhancers

This webcast features: Leisha Kopp, Applications Scientist, Mirus Bio Recombinant adenoassociated virus (AAV) and lentivirus (LV) are essential components of many gene and cell therapies designed to treat and potentially cure a vast array of acquired and heritable diseases. Thus, the need for large-scale manufacture of safe and effective viral vectors for the development of biotherapeutics has never been greater. In this webinar, we will examine critical optimization strategies that lead to simplified, defined workflows and enable higher AAV and…

Accelerating Discoveries for Viral Biology and Host Immunity with Advanced Cell Analysis Solutions

This whitepaper summaries recently published studies that incorporated the Incucyte® Live-Cell analysis platform and iQue® 3 Advanced High-Throughput Flow Cytometry. These state-of-the-art technologies were used to simplify workflows and provide rapid analysis solutions and enhanced throughput, aiding the discovery of new insights on the host-pathogen life cycle throughout the course of infection. Post-infection, these platforms were leveraged to monitor exposure, assess immune protection, and accelerate the development of anti-viral small molecules, neutralizing antibodies, and vaccines. The Incucyte® platform offers automated…

Spurring on Innovation in Gene Therapy Development

Gene therapies based on adenoassociated virus (AAV) vectors hold promise for treating myriad conditions. Immunogenicity remains a challenge for such products, however. With support from PerkinElmer, Roland W. Herzog (professor of pediatrics and Riley Children’s Foundation professor of immunology at the Indiana University School of Medicine) joined Nagendra Venkata Chemuturi (scientific director of global research for drug metabolism and pharmacokinetics, DMPK, at Takeda Pharmaceuticals) to deliver a BPI “Ask the Expert” presentation exploring strategies for minimizing immune responses to AAV-based…

Cell Media Analysis: A Critical Piece of the Bioprocessing Puzzle

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This webcast features: Graziella Piras, Bioprocess Segment Director, 908 Devices Cell culture medium remains a key component of traditional monoclonal antibody (mAb)-based biologics as well as newer modalities such as gene and cell therapies manufacturing. As such, cell culture media development and optimization continue to be an important focus for the biopharmaceutical industry. Increased analytical capabilities have provided new insights into the relationship between cell culture media, the cells they support, and ultimately the outcome of the final product. That greater insight offers more…

A Strategic Approach to Selecting the Optimal Process Intensification Scenario

Current demands placed on the biopharmaceutical industry are pushing manufacturers toward process intensification, an approach that modifies unit operations or an entire manufacturing process to optimize efficiency. Three common intensification scenarios in upstream processing are seed-train intensification (usually at the n – 1 stage), concentrated fed-batch production, and dynamic perfusion (at the production bioreactor stage). In downstream processes, intensification strategies typically involve moving from single- to multicolumn chromatography. Biomanufacturers can realize several kinds of improvements from intensified processing, including reductions…

Comparing Single-Use Multicycle Cake Filtration with Depth Filtration: Eliminating the Downstream Bottleneck

Over the past few decades, single-use (SU) technology has increased bioproduction efficiency significantly, especially with the introduction of disposable bioreactors in upstream processing. To keep pace with major developments and increases in upstream capacity, downstream processes also must increase capacity and efficiency. However, cell harvesting and downstream processing continue to present bottlenecks in manufacturing (1). Typical clarification processes are composed of primary and secondary clarification steps, such as centrifugation followed by depth filtration, respectively (1). Two sets of SU depth…

Transfection Best Practices for AAV Gene Therapy Programs

As viral vectors continue to push gene therapy innovations closer to market, many researchers are setting their sights on optimizing transfection, the process of delivering corrective genetic material into cells. It’s not just a question of how to transfect them, but also how to do so efficiently and at high volumes. Approaches that work for one cell line might not perform well for others, and transfection protocols can have different implications for scalability and cost during production for clinical trials.…

Scaling and Stirring: Success Factors in Scale Up with Single-Use Benchtop Bioreactors

This webcast features: Cristina Bernal Martinez, Applications & Support Engineer, and Ann D’Ambruoso, Manager, Product Applications and Marketing, Getinge Single-use systems allow for a faster and easier workflow while simultaneously reducing the risk of errors and contamination in the development process. Nonetheless, fundamental bioreactor principles must be understood to correctly scale up in single-use bioreactors. Learn about the design factors in Applikon’s single-use bioreactors and review common scale-up strategies based on tip speed, power input, and kLa. Furthermore, shear stress…

Using Bio-Layer Interferometry for A Fast and High Precision Influenza Vaccine Potency Assay

A fast and accurate determination of vaccine titer during manufacturing is important in understanding vaccine development process performance, and for correctly scaling each process step. The Single Radial Immunodiffusion (SRID) technique has been the most commonly used technique for vaccine titer determination. However, SRID is time consuming and generally exhibits poor precision. An alternative assay that can speed up the analysis process and provide accurate and precise potency data on different vaccine strains is therefore desirable. The Octet® platform’s Bio-Layer…

Assessing Your AAV Capsid Content for Product Quality? Get the Confidence You Need with an Automated CE Platform

Looking for a hassle-free and rapid analytical method to detect full, partially filled, and empty Adeno-associated virus (AAV) capsids for your gene therapy development? Viral capsid content can impact gene therapy product efficacy and is therefore considered a Critical Quality Attribute (CQA) that must be properly evaluated during the development and manufacturing of AAVs. Traditional analytical tools such as transmission electron microscopy (TEM), analytical ultracentrifugation (AUC), and ion-exchange chromatography (IEX) can be used to characterize capsid content but are complex…