Webinars

Bridging Anti-CHO HCP Antibodies From Two Third Generation Cygnus CHO HCP ELISA Kits by AAE-MS™

This webcast features: Eric Bishop, Vice President, Research & Development, Cygnus Technologies. A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Regulatory guidelines require that sponsors use orthogonal methods for demonstrating antibody coverage to individual HCPs and provide a comprehensive assay qualification package to ensure the HCP ELISA is fit for purpose. In this presentation,…

Transform Your AAV Analytics With Mass Photometry

This webcast features: Gareth Rogers, Product Manager, Refeyn, and Kirsty McManus, Senior Scientist, Characterization Team, Pharmaron Biologics. Mass photometry is a novel, easy-to-use bioanalytical technology that measures the empty-full AAV capsid ratio in minutes using minimal sample amounts and without the need for sample preparation. Circumventing the requirement of large capital expense and skilled operators, it can be employed in different AAV workflows. In this webinar, we present a novel mass photometry instrument called SamuxMP, which is dedicated to the…

Leveraging NISTmAb Prior Knowledge to Demonstrate Analytical Competency

The NISTmAb IgG1κ monoclonal antibody reference material, from the National Institute of Standards and Technology, is intended for use in evaluating the performance of analytical methods that determine physicochemical attributes of biologics. As a case study, Almac Sciences have assessed NISTmAb and its prior knowledge to demonstrate competency in chromatography and capillary electrophoresis methods. Key Takeaways: Analytical challenges during establishment of NISTmAb methods. Comparability assessment of NISTmAb data to demonstrate analytical competency. Transition of capillary electrophoresis methods from 32Karat software…

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…

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

This webcast features: Ivana Petrović 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…