Webinars

Formulation and Characterization Strategies for Gene Therapies

This webcast features: Sarathi Vijay Boddapati, PhD, Associate Director, Formulation and Drug Product Development, Catalent Cell and Gene Therapy Formulation studies for gene therapy products are currently limited in scope and revolve around gathering stability data at frozen storage conditions. A systematic approach towards understanding degradation mechanisms followed by buffer and excipient selection is required. Catalent Cell & Gene Therapy is working towards an approach for gathering product knowledge and establishing formulation selection criteria using traditional/routine techniques that are historically…

Thermo Scientific DynaDrive SUB: Perfusion Application and Customer Experience Highlights

This webcast features: Kristin O’Neill, Principle Scientist, and William Tran, Sr. Bioprocess Engineer, Merck & Co., Inc., and Kevin Mullen, Senior Product Manager, Thermo Fisher Scientific As the demand for single-use technologies increases in terms of performance, efficiency, and ease-of-use, Thermo Fisher Scientific has introduced a next-generation bioreactor to the biopharma industry: The Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor (SUB). Building on our extensive experience, as well as nearly two decades of end-user feedback, the HyPerforma DynaDrive SUB employs a…

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…

High-Quality and Cost-Effective Plasmid Platform

This webcast features: Dr. Shuyuan Yao, Chief Scientific Officer and Head of Research & Technology Development, WuXi Advanced Therapies In recent years, the demand for cell and gene therapy has increased substantially. The success in gene and cell therapy has also increased demand for plasmid DNA. In supplying the industry with high-quality plasmid DNA, key prominent market challenges are capacity availability, accelerated turnaround time (TAT), and affordability. In this presentation, WuXi Advanced Therapies will showcase how to address these prominent…

Stem Cell Derived Exosome Production in Stirred-Tank Bioreactors

This webcast features: Aurélie Tacheny, Project Manager and Application Specialist, and Jorge Escobar Senior Research Scientist, Applications Lab, Eppendorf Exosomes are a population of naturally occurring, mobile, membrane-limited, 30–100 nm in diameter, extracellular vesicles containing a large number of proteins, lipids, messenger, and micro-RNAs. It was shown that they play a role in the mediation of intercellular communication, the modulation of immune-regulatory processes, tumor metabolism, and regenerative as well as degenerative processes. In recent years, there has been increasing interest…

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…

New Data: A Better Way to Run CHO Cell Culture Experiments

This webcast features: Deborah Pascoe, PhD, Vice President of Operations, Culture Biosciences The bench-scale bioreactor has been the workhorse of Chinese hamster ovary (CHO) cell culture process development for decades. However, running benchtop bioreactors requires significant resources, infrastructure, and staffing. Tubing assembly, sterilization, calibration, and other setup activities can take hours to days. Tear down, cleaning, and deactivation are similarly burdensome. There are potentially large associated costs to prepare or purchase media, carry seed trains, and maintain facilities. Most critically,…

Integrated mRNA Production Process from E. coli to Highly Purified mRNA

This webcast features: Aleš Štrancar, Managing Director, BIA Separations, a Sartorius Company In vitro transcription (IVT), the enzymatic process used for the production of mRNA vaccines, differentiates itself from biological fermentation processes by the need for linearized plasmid DNA. The linear isoform is produced with restriction enzymes from open-circular and supercoiled plasmid DNA. Employing a traditional pDNA manufacturing process, which removes linear and open-circular isoforms, will reduce production yield. However, when plasmid DNA and mRNA are treated as a single…

Lentiviral Vector Platform Generation: Increase Titer and Yield with Greater Predictability

This webcast features: Xin Xin, Group Leader, Small-Scale Upstream Process Development, and Senthil Kumar Kuppuswamy, Associate Principal Scientist, Downstream Process Development, WuXi Advanced Therapies The field of cell and gene therapies has expanded rapidly in the past several years. Lentiviral vectors have been in great demand as gene carriers in this field, especially for ex vivo gene therapies. However, large-scale lentiviral vector production still remains a significant challenge. WuXi Advanced Therapies has worked with Lentivirus since 2015 and it launched…