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.…
Friday, December 10, 2021 Daily Archives
Get High-Throughput, Definitive Identification of Viable Cells and More in Your Cell Therapy
Analyzing for viable cells using traditional methods such as flow cytometry often encounters clogging resulting in the loss of precious cell therapy samples. Not only is it low throughput, but incredibly complicated, which can lead researchers to misidentify cellular and non-cellular material and confuse cell viability results with product-purity issues. Additionally, it is a regulatory requirement for all injectable drug products be characterized for sub visible particles (SVP) and aggregates that may form during a manufacturing process. With Backgrounded Membrane…
Addressing Critical Issues in Cell and Gene Therapy Manufacturing
Recombinant lentivirus (LV) and adeno-associated virus (AAV) are critical components of cell and gene therapies, which show great promise for treatment of diseases from genetic disorders to cancer. Accordingly, there is an unprecedented need for high titer and large-scale viral vector manufacturing processes to support the growing number of researchers developing biotherapeutics for immunotherapy. Download this Special Report, highlighting: Evolutions of gene therapy manufacturing Improvements to GMP raw-material sourcing. Role of transfection reagents like VirusGEN® GMP as a turnkey element…