Webinars

A Scalable Platform for GMP and High-Quality Plasmid Manufacturing

This webcast features: Dr. Mack Kuo, Associate Director BioProcess Development, Wacker Biotech US Inc. Demand for high-quality good manufacturing practice (GMP) plasmid DNA has grown significantly in the past few years. The recent proliferation of mRNA manufacturing, DNA vaccines, viral vector production, CAR T-cell therapies, and CRISPR gene editing technologies have all contributed to a bottleneck in availability of plasmid manufacturing capability. With decades of collective plasmid DNA manufacturing experience, the staff at Wacker Biotech US have released over 100…

TESSA Technology: A Plasmid-Free, Scalable System to Transform AAV Manufacture

This webcast features: Dr. Weiheng Su, Principal Scientist, OXGENE Adenoassociated virus (AAV) is a popular choice of viral vector for new gene therapies, but manufacturing systems have not kept pace with biological advances, leaving these therapies costly, difficult to produce at scale, and subject to inherent batch-to-batch variability. In this webinar, Dr. Weiheng Su describes how rethinking AAV manufacture “from the ground up” allowed OXGENE to manipulate AAV’s natural relationship with adenovirus to address these challenges with their novel tetracycline-enabled…

Big Solutions Come in Small Packages: Expanding Sterile Connection Technology to Small-Format Product or Process Fluid Volume Transfer Applications

This webcast features: Troy Ostreng, Senior Product Manager, Colder Products Company In state-of-the-art biopharmaceutical manufacturing, you’re challenged to engineer and operate processes that are robust, reliable and repeatable. Building on the inventiveness of CPC and its AseptiQuik® Series Connectors, the leader in single-use connection technology, the company’s new MicroCNX™ Series Connectors provide a modern alternative to the tube welding process. In this presentation, CPC’s biopharma senior product manager, Troy Ostreng highlights how this new category of aseptic, sterile micro-connectors provides…

Commercial Scale Insect Cell Culture: Opportunity and Challenges in a CHO Centric World

This webcast features: Sharyn Farnsworth, Principal Scientist and Upstream Process Development-Cell Culture Group Leader, FUJIFILM Diosynth Biotechnologies A strategy for scale up and manufacture of a recombinant protein from Insect Cell Culture (ICC) using a Baculovirus Expression Vector System (BEVS) should be mapped out during the earliest stages of process development. The challenges of recombinant protein expression using ICC/BEVS production systems are different from more commonly used expression systems such as Chinese hamster ovary (CHO) and few vendors have the…

Top Considerations for the Development of Inhaled Biologics

This webcast features: Ashleigh Wake, Business Development Director, Intertek Pharmaceutical Services Inhaled and nasal biologics continue to grow in importance as advantages presented both by targeted delivery to the lung and systemic delivery for other diseases or treatment pathways are driving this increased attention. In this webinar, Ashleigh Wake describes the top development considerations for inhaled or intranasal biologic analytical development. These include the need to meet regulatory requirements of ICH Q6B for a well characterized biologic as well as…

BioProcess Insider State of the Industry — September 2021 Panel Discussion

Our BioProcess Insider editorial team sits down with Joshua Speidel, PhD Partner, Latham Biopharm Group, Patrick Lucy, President and CEO, Lykan Biosciences, and Amélie Boulais, Head of Market Entry Strategy, Virus Based Therapeutics at Sartorius, to reflect on how the quarterly movements of the wider pharma industry are affecting the biomanufacturing space. Through the analysis of global events, recent deal making, and regulatory and technological advancements, we look to determine the factors driving or squeezing production and pre-empt upcoming trends…

High-Throughput IgG Titer Analysis

This webcast features: Zoe Hughes-Thomas, Head Medicine Design Automation Team, and Celal Dari, Laboratory Science Apprentice, GSK Antibodies. A key cornerstone of pharmaceuticals, from oncology to immunology. But how do we quantify them? Existing methods have proven the process needs to be improved, from long assay turnaround times to discordant results. A key method of innovating the process includes embracing new technology including automation and new assays. The presentation will introduce aspects of current methods of automation that aim to…

Improve Productivity and Operational Efficiency with Single-Use Technology

This webcast features: Rob Martindale, Product Manager, EMEA, Masterflex In many manufacturing environments, and especially in the biopharmaceutical market, there is a constant emphasis on making productivity improvements and streamlining every-day processes. One solution that many companies are turning to is the implementation of single-use technology. In this webinar, we will expand on what’s possible with single-use technology and then highlight practical ways single-use technology can make positive impacts on your workflow and on your bottom line. Just fill out…

Simplify Analytical Development for Measuring Residual Plasmid DNA in mRNA, Gene Therapy, and Other Biologics Manufacturing

This webcast features: Tania Chakrabarty, PhD, Senior Manager, Innovation Leader, Research and Development, Pharma Analytics, Thermo Fisher Scientific Plasmids are common raw materials in the manufacturing of various biotherapeutics, from use as template for mRNA vaccines to gene introduction via transfection of mammalian cells for viral vector production. Worldwide regulatory agencies (WHO, EMA, US FDA, etc.) require that clearance of residual plasmid process-related impurities via downstream purification be demonstrated to below the accepted limit in the final drug substance. Previous…

Transient Technologies to Deliver Consistently High AAV Titers

This webcast features: Dr. Jason King, Business Development Manager, OXGENE Adenoassociated virus (AAV) is often the vector of choice for gene therapies; in fact, AAV represents around 37% of the current advanced therapies market. And when it comes to manufacturing AAV for in vivo gene therapies, developers must pursue triplicate goals of quality, quantity, and speed. Here, Dr. Jason King presents the quality, titer, and regulatory advantages of OXGENE’s AAV plasmid system. He discusses the key quality considerations of WuXi Advanced…