During a December 2021 presentation, Matthew Lotti (senior research associate in analytical development at Ultragenyx) highlighted difficulties with determining adenoassociated virus (AAV) capsid titers during gene therapy production. With support from Gyros Protein Technologies, Lotti spoke about his team’s development of a method for measuring AAV titers using a Gyrolab xPand immunoassay system. Lotti’s Presentation Simple analytical methods such as UV spectrophotometry measure capsid titers most effectively after virions have undergone purification. To test samples from earlier process stages, Ultragenyx…
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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…
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…