Webinars

Ending CO2 Transmission Problems Using Purillex¬ģ 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¬ģ PFA bottles required to ensure no carbon dioxide ingress during storage and shipping of BDS products on dry ice. Key takeaways: Understand the correlation…

Analytical Tools to Improve Production of Full Capsids in Initial Stages of AAV Process Development

This webcast features: Ivana Petrovińá Koshmak, PhD, Head of Upstream Process Development, BIA Separations, now a Sartorius company. Empty AAV capsids are known contributors of immunogenicity in gene therapy products. Reducing them below 10% during downstream process is difficult if they constitute the vast majority of total AAV produced in harvest – the solution is a further optimization of harvest. Determining the factors that improve production of full AAVs is possible at the initial stages of upstream process development, with…

Streamline cGMP Viral Vector Analytical Challenges With Robust and Sensitive Impurity, Fragment Sizing, and Oncogene Quantitation Assays

This webcast features: Jonas Buege, Product Manager, Thermo Fisher Scientific. The therapeutic potential of viral vector-based gene therapies is tremendous, but with some recently adverse outcomes in clinical trials, the safety of these drugs has come into question. Both regulatory agencies and manufacturers are working hard to define appropriate critical quality attributes and identify process-related impurities crucial to ensuring patient safety. These requirements increase the demand of analytical development teams working on viral vectors, over traditional biopharmaceuticals, to utilize novel…

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…

Minimize Risk With Rapid At-Line Concentration Measurement in Downstream Bioprocessing Applications

This webcast features: Paul Mania, Bioanalytics Applications Specialist, Repligen. Traditional UV/Vis spectroscopy uses fixed pathlengths to measure different analytes, such as nucleic acids, proteins, and cells from biological samples. These samples are often limited in volume or highly concentrated, which presents various challenges. The CTech™ SoloVPE¬ģ System uses a patented variable pathlength technology (VPT) to accurately measure the targeted concentration of various analytes. The system measures concentrations without being dependent on sample volume or sample concentration, removing any dilution requirements,…

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.…

Drug Discovery: Screening Approaches for Rapid Assessment of Target Tractability

This webcast features: Nuska Tschammer, Head of DEL Lab Operations, WuXi AppTec. In recent years, increasing use of genetic, transcriptional and knock-out technologies led to numerous biologically validated targets, many of them in the category ‚Äúfirst-in-class‚ÄĚ. The core purpose of experimentally based tractability assessments is to evaluate if the target of interest can be modulated by a chemical entity. In the past, extensive HTS screening efforts were initiated to find starting points for the small molecule drug discovery. Today, direct…

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…