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Case Study – Merck Process Transfer and Scale-Up of Batch Chromatography to Multi-Column Platform

Traditional batch chromatography has high operating costs. Merck sought to evaluate the relative performance and costs of an MCC system. Learn how Merck achieved resin savings and productivity gains by implementing multi-column chromatography with the BioSMB system. Key Learning Objectives: Learn how Merck achieved 3.5x higher productivity with MCC compared to batch mode See how the shift resulted in 80% reduction in chromatographic resin use Find out how Sartorius experts supported Merck’s process transfer Access this case study and learn…

Visit and work with the M Lab™ Collaboration Centers from the comfort of your own lab

Welcome to the M Lab™ Collaboration Centers where life science innovators come to explore big ideas, learn new techniques, and rapidly move from complex problems to just-right solutions–together. Using world-class remote technologies, you can do all this from the comfort of your own lab! We have expanded the walls of our labs by using the latest technology to bring you virtual visits or livestream trainings to support all areas of process development, implementation, and optimization. When you bring a problem…

Converting an ELISA Assay into an Octet® BLI Quantitation Assay

Enzyme-linked immunosorbent assays (ELISA) are routinely used to quantitate molecules and despite their popularity, these assays are labor- and time-intensive. Quantitation assays on the Octet® platform can be considered automated forms of ELISA but allow a myriad of benefits compared to standard ELISA assays, notably the ability to detect lower affinity interactions and a reduced hands-on time for the scientist. As with ELISA, the signal reported in quantitation assays is either directly or inversely proportional to the amount of bound…

CO2 Transmission Into Bulk Drug Substance Containers

Ingress of carbon dioxide into bulk drug substance (BDS) containers that are stored and shipped on dry ice is a serious and often understated problem. Bottles are a container of choice for freezing and shipping BDS due to their durability and convenience, compatibility with standard laboratory equipment, shelving and racking, and standard shipping containers. However, not all bottles are tested for CCI, nor does this testing guarantee leak-free performance once frozen. Carbon dioxide can readily enter bottles either through the…

Virtual Demonstration of the BioSMB Multi-Column Chromatography Platform

In this virtual demonstration, our intensified processing solutions expert provides a virtual demonstration of the BioSMB multi-column chromatography platform — a fully scalable single-use solution that reduces resin usage and enables manufacturers to explore continuous processing. The demo starts with an overview of the BioSMB PD system for small-scale manufacturing and then continues with the BioSMB Process systems for clinical and commercial manufacturing. Key learning objectives: Learn how the BioSMB system offers a 3-5 fold increase in productivity, yielding up…

The Critical Role of Predictive Bioreactor Characterization in Pharmaceutical Process-based Upscaling

In bioreactors, microorganisms or cell cultures produce complex therapeutic proteins and other biopharmaceuticals. The industrial production of those active pharmaceutical ingredients usually involves a seed train: the cells are run through many cultivation systems, which become larger with each passage (Upstream Process). An adequate number of cells for the inoculation of large-scale production bioreactors of 10,000 liters or more is generated. A prominent example from the growing mammalian cell culture processing sector is the upstream production process of monoclonal antibodies.…

Rapid Process Development: How a Synthetic Depth Filter Offers a Platform Approach for Efficient Virus Filtration Operations

Virus filtration is a critical unit operation in recombinant protein purification processes. Process development of virus filtration operations typically strives to maximize filter capacity and improve process robustness. Adsorptive prefilters are often used to remove higher order protein aggregates and improve filter capacity. While adsorptive membrane prefilters offer easy scale up and implementation, their narrow operating window may result in extensive process development screening studies. By contrast, synthetic depth filters offer a wide operating window and the potential for a…

Intensified Mammalian Cell Culture: Harvest with a Single-Use Hermetic Centrifuge System

The production of increasingly higher cell densities has stressed the already limited solids-handling capabilities for traditional intermittent ejection centrifuge systems. By contrast, a single-use disc-stack centrifuge based on the solids-flow principle offers distinct advantages for cell culture harvesting. Such benefits include solids handling of high-density cell culture processes and elimination of the separation disruption and aerosol generation associated with the intermittent solids ejection. A single-use system also provides well-established benefits of disposable components — such as removal of steam- and…

Comparison of Gator BLI and Progen ELISA for Quantitation of AAV Serotypes

The determination of total capsid titer is one of the critical quality attributes for AAVs used in gene therapy. This application note presents quantitation of AAV serotype 2, 5, 8 and 9 using GatorPrime™ system and Gator™ AAVX probes, and compares the performance with Progen Xpress ELISA assay for the same serotypes. The Progen ELISA kit is commonly used for AAV quantitation and while it performs well, it has several drawbacks for routine operation, viz, need to dilute the samples…

Security of Supply Risk Mitigation in HCP Monitoring

The most common method scientists use to monitor host cell protein (HCP) levels in biologics is the enzyme-linked immunosorbent assay (ELISA). For the reagent, security of supply is a regulatory requirement ⁠— it’s a factor that’s critical to consistently monitoring HCP during biologic production. In this webinar, we discuss why security of supply is important, the consequences of not having it, and how to mitigate this risk. Topics covered Why security of supply is critical to your HCP plans Consequences…