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| No matter how robust and consistent your assays are today, the time will come when a tech transfer, a scale-up, a supplier change, a partnership deal, or some other force of change requires an analytical methods transfer. You should be preparing for that day. Join Bioprocess Online Live on December 3rd for best practices to ensure the methods you're developing today are seamlessly transferrable tomorrow. Registration is free thanks to the support of BD Bioscience. |
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FOCUS ON PROCESS ENGINEERING |
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By Tyler Menichiello, contributing editor and Matt Pillar, chief editor | Leona Ling, Ph.D.’s relationship with the investigational monoclonal antibody nipocalimab is defined by curiosity, perseverance, and commitment. She discovered the molecule while working for Momenta Pharmaceuticals, and she continues to shepherd it long after J&J's $6.5 billion bid for it in 2020. |
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| The Impact Of Tip-Based Systems And Jetting Technology | Application Note | Ecolab, Purolite Resins | Discover how protein A resins with superior binding capacity and elution efficiency transform high throughput process development for mAb purification, optimizing results and reducing time to market. |
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| Introduction To mRNA Manufacturing | Article | Cytiva | The SARS-CoV-2 virus has changed the course of scientific research around mRNA. Learn about mRNA manufacturing, the structure of a mRNA molecule, RNase-free considerations, and more. |
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| Validating Antibodies With Knock-Out Technologies | Webinar | Danaher Life Sciences | Watch to learn about how one company achieves antibody validation through knock-out (KO) technologies as well as the significance of gene KO technologies in the large-scale screening of antibodies. |
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| Technology Transfer Considerations | Article | MilliporeSigma | Speed and flexibility are crucial in the development of a new drug, from the laboratory to clinical trials and ultimately to the market. Explore considerations for a successful technology transfer. |
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| Streamlined Cell Therapy Development | Article | By Bruce Thompson, Kincell Bio | Learn about the initial stages of product development — specifically, how to move from candidate selection to a Phase 1 Investigational New Drug (IND) application. |
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| Transient Expression Technologies For Antibody Production | Poster | By Anthony Lauer, James Ludtke, Chuenchanok Khodthong, Shannon Bruse, and Laura Juckem, Mirus Bio | Review studies that showcase the potential of the CHOgro Expression System in early stage drug development, where high titer antibody production in suspension CHO cells is crucial. |
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| Hosts For Vaccine And Virus Expression: Insect Cell Expression Systems | Article | By Laura Walls, Ph.D. and Sharyn Farnsworth, FUJIFILM Diosynth Biotechnologies | Choosing the right host is key to creating scalable, robust, and reliable commercial processes. Explore common challenges associated with the insect cell culture/baculovirus expression vector systems platform. |
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| Super Short Activated CAR-T Process | Application Note | Resilience US, Inc. | Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs. |
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PROCESS ENGINEERING SOLUTIONS |
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FOCUS ON FACILITIES DESIGN |
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By Paschal Iwuh, Ph.D., Pharmatech Associates—a USP company | This article provides an overview of the facility considerations for tissue engineering. It includes a comparison of a bulk biologics facility, which aids the discussion. |
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| Labware Washing Techniques And The Sinner's Circle | White Paper | Getinge | Explore labware cleaning techniques, comparing manual and automated processes, and how balancing the four factors of the Sinner’s Circle ensures effective, repeatable laboratory outcomes. |
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| How To Prove A Sterility Assurance Level Of 10⁻⁶ | Article | By Kurt McCauley and Laurent Berliet, Mesa Laboratories | Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products along with the prerequisite studies needed to develop the sterilization process. |
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FACILITIES DESIGN SOLUTIONS |
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