Bioprocessing Application Notes & Case Studies

1. Cell Therapy Manufacturing With The ekko™ System: DMSO Removal for Thawed Apheresis Material 7/22/2021

   For CAR-T processes that require a freezing step between apheresis collection and manufacturing, it is critical upon thaw to remove Dimethyl sulfoxide (DMSO), a standard component of cryoprotectants, from the product to ensure the utmost cellular health of the apheresis material. In this application note, we demonstrate how the ekko™ Acoustic Cell Processing System consistently processes apheresis products.

2. Natrix® Q Chromatography Membrane 7/20/2021

   Strong anion exchange (AEX) chromatography has become an industry standard in polishing steps for monoclonal antibody (MAb) purification. It is a proven technology to remove DNA, viruses, endotoxins and acidic host cell proteins (HCP) from process feed streams in flowthrough mode. This application note examines the performance of Natrix® Q chromatography membrane in comparison to currently available quaternary amine resins, membranes and salt-tolerant primary amine membranes.

3. Pellicon® 3 Cassettes Cleaning Methodology For Reuse In Single-Pass Tangential Flow Filtration Mode 7/13/2021

   Single-pass tangential flow filtration (SPTFF) can be used to achieve higher final concentrations, optimize product recovery, control volume of intermediate steps, and enable intensified or continuous processing with chromatography or filtration operations. This study demonstrates efficient cleaning strategies to enable multiple reuse of TFF cassettes for high concentration applications with SPTFF.

4. Finding Fermentation Contaminants Faster With Fluorescence-Based Rapid Microbial Detection 7/9/2021

   Traditional bioburden testing can take several days to show visible colonies. Earlier detection makes it possible to address fermentation contamination events sooner, avoiding reactor shutdowns and downstream problems. The Milliflex® Quantum system can quantitatively detect microbial contamination in filterable samples up to three times faster than traditional plate-based monitoring methods.

5. Comparison Between Experimental Data And Computational Fluid Dynamics In Mixing Applications 7/9/2021

   In biomanufacturing processes, mixing is ubiquitous and mixing trials are often necessary to assess if a technical solution is adapted for a given process step or to optimize process parameters. Discover how computational fluid dynamics can help in your mixing trials.

6. Virus Filtration Assurance Through Automation 7/8/2021

   Learn how to achieve virus filtration assurance with a purpose-built automation software that integrates our filtration expertise into your manufacturing suite at every step of the process.

7. One-Step Isolation And Activation Of Naive And Early Memory T Cells With CTS Dynabeads CD3/CD28 7/6/2021

   In this application note we demonstrate nearly 100% recovery of naive and early memory T cells using Gibco™ CTS™ Dynabeads™ CD3/CD28 beads. This one-step process of simultaneous T cell isolation and activation yields pure and uniformly activated T cells.

8. Highly Sensitive Charge Variant Analysis Of Complex Biopharmaceuticals 6/29/2021

   This case study explores the use of a capillary electrophoresis device to perform highly selective charge variant separation of complex pharmaceuticals for native intact antibodies while generating excellent quality MS data. This technology allows for in-depth analysis of extremely low abundant charge variants with outstanding method sensitivity. 

9. Identifying The Decision-Makers At Your Customers’ Organizations 6/29/2021

   ISR was engaged by the Global Marketing Director at a Top 20 CDMO with the above question. The client had years of experience in marketing their brand to prospective customers but had recently begun to question the efficiency of their marketing spend. The client wanted to demonstrate to their company stakeholders that their marketing efforts were not only hitting the right targets, but that the language used in those efforts reflected their customers’ needs. Knowing this information would allow the client’s marketing department to move away from broad, product-based messaging focused on how good their services are, to messaging focused on how their services address their customers’ concerns.

10. Targeting Once Inaccessible Phospho-Proteins With RePlex 6/17/2021

    Vividion Therapeutics is a small molecule company harnessing its expertise in target biology, chemistry, and mass spectrometry to transform the future of human health. They were frustrated with their process when monitoring quantitative phospho-protein changes as it was notoriously problematic and slow. By transferring their assays over to Simple Western™ with Jess™ combined with Jess’ RePlex™ module they are able to increase throughput and improve the accuracy of his phospho-protein quantification.