This webcast features: Tim Kelly, CEO, Oxford Biomedica Solutions. It is now fully apparent that product quality is critical to the performance of gene therapy products. In turn, regulatory expectations have risen dramatically for the quality of the viral vectors that are used to deliver such therapies. That said, yields from viral-vector production processes tend to be much lower than those for conventional protein products. The ability to address all aspects of product quality while still achieving high vector output…

This webcast features: Graziella Piras, PhD, Bioprocessing Segment Director, 908 Devices. Unlike biotherapeutic proteins that benefit from decades of development and manufacturing experience, cell and gene therapies are still young. Producing these diverse therapeutics requires that various cells be used based on the specific application. Since various cells have different requirements, the medium used to culture them must be designed for optimal growth and/or productivity of each cell type. When the composition of the cell culture medium does not match…

This webcast features: Yiyu Dong, PhD, Associate Director of Viral Vector Process Technology Development (VVPTD), WuXi Advanced Therapies. Due to their capability for long-term transgene expression, large packaging capacity and ability to transduce postmitotic and quiescent cells, lentiviral vectors have become increasingly popular gene delivery tools for cell and gene therapies in recent years. However, capacity for lentiviral vector manufacture is a major industry bottleneck. WuXi Advanced Therapies has developed a lentiviral suspension manufacturing platform using OXGENE’s XLenti™ packaging plasmids.…

This webcast features: Kalhari Silva, PhD, Head of Scientific Research, Custom Biologics, and Bob Dass, PhD, Senior Scientist, Octet Applications, Sartorius. Quantifying critical quality attributes accurately and precisely is an important aspect of regulatory compliance. There is greater demand to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy of biotherapeutics. Kalhari Silva, from Custom Biologics, will provide insight on how her team designs and establishes methods suitable for comparability studies that allow for their future…

This webcast features: Andreas Solomos, PhD, Director, Virology Operations, WuXi Advanced Therapies. Cell and gene therapy regulatory testing is a constantly evolving discipline as the field matures and data becomes more refined. Virology Operations at WuXi Advanced Therapies is able to provide testing for a variety of products ranging from small non-enveloped AAV vectors to large enveloped lentiviral vectors. Our testing is performed as quickly as testing parameters permit without sacrificing the quality and integrity of results. Our panel of testing…

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…