Webinars

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…

Optimization of an Anion Exchange Method for the Large-Scale Production of Plasmid DNA for Gene Therapy and DNA Vaccine Applications

This webcast features: Jenny England, Staff Scientist, Innovation & Applications, Thermo Fisher The advancement of gene therapy and plasmid DNA (pDNA) vaccines has highlighted the need for the development of a large-scale purification process to produce high purity plasmid DNA. Plasmid DNA serves as a foundation to produce viral vectors such as adenoassociated virus (AAV) or lentivirus (LV), a template for mRNA production during the in vitro transcription reaction and can be used directly as a pDNA vaccine. The typical…

Analytical Ultracentrifugation for Profiling AAV Gene Therapies: Where Are We Now?

This webcast features: Yijun Huang, Scientific Fellow, WuXi Advanced Therapies Adenoassociated virus (AAV) is often the vector of choice for gene therapies due to their low immunogenicity, ability to promote long-term gene expression, and capsid tropism-dependent tissue specificity. Representing around 37% of the current advanced therapies market, there is an ongoing demand for robust quality lot release programs capable of supporting the large patient cohorts involved in clinical trials. Along with critical quality attributes such as titer, identity, and potency,…

Container Closure Integrity: Testing of Bottles Used for Cell Therapy Applications

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex Container integrity is critical when storing and shipping cell therapy products to ensure sterility. The security and durability of the container sealing region(s) should be weighed against usability of the container in clinical settings common to cell therapies. A study was performed to evaluate and quantitatively measure the associated leak rate for the container closure integrity of fluoropolymer bottles per USP <1207> Package Integrity Evaluation – Sterile Products using helium…

Optimized Expression Systems for Increased Productivity in CHO DG44 Based Cell Line Development

This webcast features: Dr. Rathangadhara Nammalwar, Team Lead, Cell Line Development for Protein-Based Therapeutics, Sartorius The Global Cell Line Development (CLD) services market is growing at an unprecedented pace. In 2020, the global revenues were about $700 million and are estimated to reach nearly $1.7 billion by 2028. Chinese hamster ovary (CHO) cells have been the most preferred host cell line for those CLD services, and they alone generated more than 50% of the global revenue in 2020. Key success…

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…

Cell Media Analysis: A Critical Piece of the Bioprocessing Puzzle

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…