Analytical Tools for PAT Implementation for the Characterization of Biosimilars

July 30, 2020

This event will aim to present an overview of how analytical technologies can be adapted for implementation of Process Analytical Technology (PAT) in bioprocessing and how this can result in effective process control, thereby delivering consistent process performance and product quality. Live: Europe Broadcast: Thursday, Jul. 30, 2020 at 9am EDT| 2pm BST| 3pm CEST US Broadcast: Thursday, Jul. 30, 2020 at 2pm EDT| 1pm CDT| 11am PDT On demand available after final airing until Jul. 30, 2021

Editors’ Series: Cell and Gene Therapies: Laying the Foundation for a New Supply Chain

July 29, 2020

Existing biopharma supply chain practices must evolve to meet the needs of personalized therapies, particularly for autologous treatments. Force fitting manual processes will no longer work. Hear about lessons learned in a pioneering “vein to vein” pilot program that aims to establish new rules for data management and exchange, scheduling, and automating workflow and supply chain practices for novel and complex processes. Live: Wednesday, Jul. 29, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 29, 2021 Register free

Editors’ Series: Overcoming Commercialization Challenges for Cell Therapies and Gene Therapies

July 28, 2020

The complexities of producing cell therapies and gene therapies are testing established biomanufacturing practices and the companies engaged in producing the treatment. Join this webcast to hear about the technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization. Live: Tuesday, Jul. 28, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 28, 2021 Register free

Editors’ Series: Genotoxic Impurities and Drug Quality: Lessons from the Nitrosamine Contamination Crisis

July 14, 2020

The discovery of nitrosamine-based impurities in APIs has triggered recalls of commonly used drugs and placed the quality of the drug supply in question. Learn best practices for identifying impurities in drug substances and drug products and the roles and responsibilities of ingredients suppliers, drug manufacturers, and regulatory authorities. Live:Tuesday, Jul. 14, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On Demand: available after airing until Jul. 14, 2021 Register free

Validation of LC-MS Multi-Attribute Method (MAM) Supporting Biopharma Process Characterization

June 30, 2020

An automated multi-attribute method (MAM) approach providing high-throughput, user-friendly analysis of process validation samples is moving mass spectrometry toward biopharma quality control. Learn how to implement automated MAM approaches for process development and validation and streamline approaches using a single scalable enterprise software platform. Live: Tuesday, Jun. 30, 2020 at 10am EDT | 9am CDT | 2pm BST | 3pm CEST On demand available after final airing Jun. 30, 2021 Register free

Host Cell Protein (HCP) Immunoassays and Role of Mass Spectrometry in Identification of HCP Impurities in Downstream Samples

June 16, 2020

How can you better identify those host cell proteins (HCPs) that might co-purify with your drug substance (DS) and elicit an undesired immune response, interfere with drug safety and efficacy, or impact DS stability? Cygnus Technologies VP of R&D, Eric Bishop, will discuss powerful orthogonal methods such as immunoaffinity chromatography and mass spectrometry that enable full understanding of those HCPs that are present in the product and could potentially impact patient safety and drug stability. Live: Tuesday, Jun. 16, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after airing until Jun. 16, 2021 Register free

Accurate Weighing of Reference Standards in a QC Laboratory

May 28, 2020

For any quantitative HPLC experiment, the accurate preparation of verified standards is necessary and reliant on accurate weighing procedures. Learn about practices to ensure accurate measurements in quality control laboratories. Live: Thursday, May 28, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after airing until May 28, 2021 Register free

Viral Vector Process Development: Applying CE and MS Techniques for In-Process Testing

May 27, 2020

Fast growth in cell and gene therapy industry has generated an urgent need for fast and robust analytics for characterization and impurity determination for viral vectors. Mass spectrometry (MS) and capillary electrophoresis (CE) open up new avenues to enable fast and actionable analytics to enable quicker development and commercialization of gene therapies. Live: Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until May 27, 2021

Practical Method Development Strategies for the Analysis of Monoclonal Antibodies by Reversed-Phase HPLC

May 21, 2020

Learn how to achieve better resolution, reproducibility, and quality data for intact mAb and sub-unit analysis. In this webcast, Brian Rivera will review method optimization for a new wide pore C4 core-shell particle that further exhibits improved efficiency and robust separation for large molecules. Live: Thursday, May 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing May 21, 2021 Register free

From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors

May 21, 2020

Join Ankita Desai from Eppendorf and Arie Reijerkerk from Ncardia in this webcast and Q&A session to learn about the benefits of stirred-tank bioreactors for the drug discovery and development process. Get insights about how the advent of human-induced pluripotent stem cell (hiPSC) technology has substantially expanded the availability of human cells. On demand available until May 21, 2021 Register free