Manufacturing

Improving Gene Therapy Viral Vector Manufacturing Economics: Modelling Bioprocess Costs

Gene therapy viral vector manufacturers strive to reduce time to market and cost per dose to ensure treatment affordability and patient access. Approved and commercialized AAV-based gene therapies Luxturna® and Zolgensma®, for patients suffering from vision loss and spinal muscular atrophy, are the first of many gene therapies that are expected to reach the market in the coming years. One major bottleneck is the cost per dose of the treatments, with Luxturna® costing almost half a million dollars per eye…

Stability Assessment of mRNA Formulations – Toward the Development of Degradation Assays for mRNA-based Vaccines

This webcast features: Caio Henrique Barros, PhD, Research Scientist, National Institute for Bioprocessing Research and Training & James Geiger, PhD, Field Application Scientist, PerkinElmer. The COVID-19 pandemic has demonstrated the potential of mRNA vaccines to protect against infectious diseases. These unprecedented circumstances have also highlighted the instability of the mRNA molecule, which required the first COVID vaccines to be distributed at ultracold temperatures. This limitation has intensified efforts to develop mRNA formulations that are sufficiently stable at room temperature. Dried…

High Performance With GMP Ready CHT Prepacked Process-Scale Columns

This webcast features: Khaled S. Mriziq, PhD, Senior Marketing Manager, Process Chromatography, Bio-Rad Laboratories. In this webinar, we will present performance data for the newly launched, GMP ready CHT™ Ceramic Hydroxyapatite prepacked process-scale columns. This will include HETP and asymmetry data that shows excellent column performance and shipping stability over a range of column diameters. The columns are designed to eliminate any headspace formation during transportation. Cycling and pressure data will also be presented. Foresight Pro Columns can be used…

Moving Beyond PEI: Improved Transfection Processes for AAV and LV Manufacture

GMP-compliant nucleic acid delivery to HEK 293 cells is often a critical first step in the manufacture of advanced therapies, utilizing recombinant adeno-associated virus (AAV) or lentivirus (LV) to facilitate delivery of a therapeutic transgene to patients. Accordingly, the need for safe and reproducible large-scale viral vector manufacture processes has never been greater. Mirus Bio has developed a fully synthetic, innovative transfection formulation to enable higher titer AAV and LV generation and reduce the cost of therapeutic development and manufacture…

Ending CO2 Transmission Problems Using Purillex® Containers

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex. Ingress of carbon dioxide into bulk drug substance (BDS) containers that are stored and shipped on dry ice is a serious and often understated problem. This webinar outlines two studies performed by a major biopharmaceutical company to determine the closure style and torque specification of Purillex® PFA bottles required to ensure no carbon dioxide ingress during storage and shipping of BDS products on dry ice. Key takeaways: Understand the correlation…

Comprehensive Virus Clearance Evaluation Using Micro-Scale Membrane Adsorbers

This webcast features: Sherri Dolan, Global Technology Consultant for Virus Clearance, Sartorius. When it comes to establishing a viral clearance process, ensuring patient safety is a top priority. To ensure this, regulators require that manufacturing processes have a validated cGMP purification process that can remove and/or inactivate a variety of viruses. Additionally, process efficiency and cost, among other factors, play a role in small- and large-scale manufacturing processes. Many biopharma manufacturers are not yet utilizing the full loading potential of…

Product Quality in Focus

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…

The Critical Role of Cell Culture Media Analysis in Cell and Gene Therapies Development

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…

Developing a Platform for Large-Scale Lentiviral Manufacture

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.…

Developing Methods for Comparability Studies of Therapeutic Monoclonal Antibodies: Minimize Time, Maintain Quality

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…