Webinars Archives - Page 7 of 27 - BioProcess InternationalBioProcess International

Automation of a Next-Generation Sequencing Method for Cell Line Species Identity

This webcast features: Dr. Christine Mitchell, Scientific Fellow, Analytical Development, WuXi Advanced Therapies As the gene and cell therapy market continues to expand, affordability and accelerated turnaround time (TAT) become increasingly important in the industry. Despite the escalating diversity of therapeutic modalities, the criticality of a robust cell bank remains a pivotal starting point for many biological products. The integrity of species identity for cell lines is a critical quality attribute for many cell and gene therapies, and with regulatory…

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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…

Formulation and Characterization Strategies for Gene Therapies

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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…