Downstream

Simplifying AAV Downstream Process and Product Characterization: A Look at Purification and Analytical Tools

This webcast features: Dr. Julia Baek, PhD, Staff Specialist, Ilaria Scarfone, PhD, MBA, Field Applications Specialist, and Chantelle Gaskin, Field Applications Specialist, Thermo Fisher The optimization of the downstream process for adeno-associated virus (AAV) production with consistent quality depends on the ability to characterize critical quality attributes affecting potency, purity, and safety of the final product. As the gene therapy field continues to push products through the clinical pipeline, an increasing need for efficient analytical tools has become evident. In…

Mixed-Mode Chromatography: Optimizing Target Purity and Recovery with Buffer Additives

This webcast features: Xuemei He, PhD, R&D Manager of Chromatography Media Chemistry, Bio-Rad Laboratories New biotherapeutic constructs continue to increase in biopharmaceutical development, extending treatment options to a broad range of diseases we face today. These biopharmaceuticals include recombinant proteins, monoclonal antibodies, antibody drug conjugates, bispecifics, viruses, and virus-like particles to mention a few. A simple, straightforward approach to the production of these biomolecules is required to meet the current demand for process efficiency and economics. Innovative chromatographic methods facilitate…

Inducible Secretion with ESETEC: The Solution for Difficult-to-Produce Proteins

This webcast features: Dr. Marcel Thoen, Head of Global Competence Center for Cell Line Development, Wacker Biotech Escherichia coli is the most popular expression system for all nonglycosylated biopharmaceuticals. However, common challenges include purification of expressed proteins recovered from the periplasm or those needing refolding from inclusion bodies. These constraints have been addressed by the unique secretion E. coli expression system ESETEC (E. coli secretion technology) developed by Wacker Biotech. Through years of experience, Wacker Biotech has observed that secretion…

Ensuring Viral Safety in Cell & Gene Therapy Through Next-Generation Sequencing

This webcast features: Horst Ruppach, Senior Scientific and Portfolio Director, Global Biologics, Charles River The viral contamination risk of cell and gene therapy products is significant. Multiple factors open the windows for viruses to enter the process. The current viral risk mitigation strategies have limitations and can either not be applied or have limitations to cover a broader range of potential viral contaminants. One of the most important entry points to monitor are the cells. They are used to produce…

Virus-Like Particle Production in Insect Cells Using the Baculovirus Expression System: Addressing Challenges across the Workflow

This webcast features: Maya Yovcheva, R&D Scientist, Cell Biology, Chantelle Gaskin, Field Applications Scientist, Purification, and Florian Durst, Sr. Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific Being part of the newer generation of vaccines, virus-like particles (VLPs) have proven to be effective in humans as well as animals. VLPs mimic the structure of the virus particles they are derived from and are highly immunogenic, but they lack the virus genomic material which gives them a favorable safety profile. The…

Manufacturing a Recombinant Retrovirus: Downstream Purification Process Development through GMP Implementation

This webcast features: Mark Fitchmun, President and CEO, Somatek, Inc. Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. In this webinar, a case study will be presented and will detail the importance of resin screening, endonuclease treatment, process development, and the scale-up purification of a retrovirus-like particle intended for use in human subjects. The resulting current good manufacturing practice (CGMP) compatible process required approximately four hours to purify 240 L of…

Increase Efficiency in Your Manufacturing With the Right Buffer Management Strategy

This webcast features: Jenny Dunker, Global Product Manager, and Alex Troken, Global Product Manager, Cytiva Buffer preparation is still a highly manual activity in the biopharmaceutical industry that often requires a lot of resources due to the large number and overall volume of buffers and process liquids used in a typical bioprocess workflow. Most companies are still relying on the traditional ways of preparing buffers, but there are more modern, alternative buffer preparation methods that can bring significant savings and…

HCP Analysis using Mass Spectrometry: Strategies for Your Process Development Toolkit

This webcast features: Dr. Christina Morris, Senior Scientist, BioPharmaSpec Expression systems of either mammalian, yeast, or bacterial origin are commonly used as host cells for the production of biopharmaceuticals. As a consequence of using these systems, endogenous host cell proteins (HCPs) will inevitably copurify or will be coexpressed and contaminate the product material. It is a regulatory requirement to identify and monitor process-related impurities such as HCPs, and a qualitative and quantitative assessment of the components in the final drug…

Understanding Viral Clearance During Anion Exchange Chromatography by Using a Novel Design of Experiment Approach

This webcast features: Moira Lynch, Innovation Leader, Purification and Pharma Analytics, Thermo Fisher Scientific, and Zhijun (George) Tan, Associate Scientific Director, Bristol Myers Squibb Demonstrating viral clearance of a downstream process is a requirement for drug candidates such as monoclonal antibodies (mAbs) that proceed to phased clinical trials. Due to the specialized nature of viral clearance studies, these studies are often outsourced to dedicated companies, making this a costly process. This expense pushes these studies off until absolutely necessary and…

MS-Based Impurities Investigations in Biopharmaceutical Laboratories

This webcast features: Andrew Hanneman, Scientific Advisor, Charles River Laboratories One of the major challenges to developing successful biopharmaceutical products is understanding and characterizing potential impurities. Finding the source and magnitude of these impurities allows us to minimize and remove them during the manufacturing process to create a safe and effective drug. Development also needs to include supporting stability and forced degradation studies to ensure long-term safety and efficacy. Some impurities, such as protein degradants, host cell proteins, and various…