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Ask the Expert: Leveraging Quality Management Systems to Achieve Competitive Advantages

During a May 2021 “Ask the Expert” presentation, Jigisha Patel (vice president of global regulatory compliance and technical services at Spectrum Chemical Manufacturing Corporation) emphasized the need to minimize supply-chain contingencies that lead to variability across raw materials used in biopharmaceutical manufacturing. Deviations in raw-material specifications can jeopardize good manufacturing practice (GMP) compliance and reduce drug-product efficacy and stability. Patel explained how her company’s quality management system ensures that bioprocess materials will meet specifications and process needs. Patel’s Presentation Patel…

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…

Tools to Support COVID-19 Patient Testing

To prepare adequate healthcare measures in the case of a pandemic, vast numbers of people must be tested in order to understand the dynamics and behavior of the infection cycle. The medical staff working under extreme circumstances need basic but reliable laboratory supplies to help contain the pandemic. Read this special report to discover two solutions for COVID-19 patient testing that comply with guidelines from the US Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). The…

Accelerating the Development and Manufacture of Therapeutics Using the Octet Platform

The high costs of therapeutic discovery, development, and manufacture require improved process efficiencies and economics. Analytical tools that eliminate the need for reagent labeling and enable real-time data visualization save development time and improve efficiencies during process development. The Octet biolayer interferometry (BLI) platform and assays can be used throughout process development and manufacturing, including cell-line development, clone selection, and dynamic binding capacity (DBC) determination for affinity purification columns. The ability of the Octet BLI platform to monitor binding interactions…

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…

Minimize Risks and Enhance Speed and Flexibility with Sterile Fill/Finish Support for Clinical Supplies

Industry changes, such as shorter timelines and increased product complexity, can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Additionally, the advent of personalized medicines brings challenges to manufacturing and supply chain structure, emphasizing the need for speed and flexibility. Join Eurofins BioPharma Product Testing and Vanrx (now part of Cytiva), for an in-depth discussion covering ways to eliminate human error and other associated risks when producing small batches of…

Managing Frozen Transport Logistics in the Biopharmaceutical Cold Chain

The enormous task of establishing a reliable infrastructure to supply COVID-19 vaccines across the globe has thrust cold chain shipping and its associated challenges into the spotlight. Valuable biologics, such as vaccines and recombinant therapeutic proteins, are often kept in a frozen state during storage and shipping. This requires robust solutions to ensure temperatures do not fluctuate and product integrity is preserved. As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become…

How to Find Expression and Purification Conditions That Result in High Levels of Thermally Stable Membrane Proteins

It’s very common to experience low expression levels when producing membrane proteins — plus they’re finicky and unstable when they’re outside of their native environment. Just know, you’re not alone. In this webinar, we’ll introduce you to the latest technology and techniques that will help you: More easily find the best expression and purification conditions that yield properly folded membrane proteins, saving you time and resources in producing membrane proteins that are stable and functional for downstream use Characterize the…

rEVolutionizing Acellular Therapies with Corning HYPER Technology

This webcast features: Amy C. Kauffman, PhD, Senior Development Engineer, Corning Life Sciences Extracellular vesicles (EVs) are a population of particles that are naturally released from cells. They are involved in intercellular communication, providing the necessary factors to mediate physiological events, and they are of high interest because of their potential for becoming the next generation of therapeutics. One potential area of interest is in generating an EV therapeutic in place of mesenchymal stem cell (MSC) therapies for pathological conditions…

Optimizing the Accuracy of Biopharma Flow-Measurement Applications With the BioProTT™ FlowMeasurement System

The BioProTTTM FlowMeasurement System for the non-invasive measurement of volumetric flows within flexible tubing systems is suitable for both industrial and laboratory applications. It always consists of an evaluation device and a sensor. To ensure the highest possible accuracy, each sensor is adjusted and calibrated according to certain parameters based on the customer’s application. In addition, there are also external factors that impact the accuracy. This document will highlight and explain these factors so that system integrators and operators are…