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By Petra Rempe, Ph.D. | Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them. | |
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| Webinar: Best Practices for PUPSIT Assembly Design and Operation | This webinar explores the design and implementation of PUPSIT in sterile filtration, covering regulatory expectations, system configurations, equipment layout, and integration into existing processes. It includes practical examples, design challenges, and best practices for integrity testing. Key topics include regulatory guidance, single-use integration, common test devices, and pitfalls to avoid, with a Q&A session for participant-specific concerns. Click here to learn more. |
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FOCUS ON QUALITY/ANALYTICAL METHODS |
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By Bioprocess Online Live | In this segment from the Bioprocess Online Live event, “Challenges And Considerations For Purifying Multispecific Molecules,” panelists Mark Fitchmun and Dr. Jian Ren emphasize the importance of good analytics for your purification strategy. | |
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| Best Approaches To Operational Readiness | Webinar | CAI | Learn how to implement a focused operational readiness model that goes beyond traditional construction and startup schedules. Discover how this approach can reduce timelines and improve project success. |
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| Process Analytical Technology In The ADC Bioconjugation Process | White Paper | By Haowei Song, Yiyi Li, Kim Nguyen, Jake Spikes, Mary Ramisetty, Gang Yao, and Lisa MacDermott, MilliporeSigma | Integrating PAT into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production. |
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| The Importance Of Reliable Mixing In ITC Experiments | Article | By Morgan Ulrich and Calliste Scholl, TA Instruments | Examine how ITC precisely analyzes molecular interactions, which provides crucial thermodynamic data to understand physiological processes and develop new therapeutic strategies. |
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| Labware Washing Techniques And The Sinner's Circle | White Paper | Getinge | Study 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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| CQA Assessment Of LNP-Encapsulated IVT mRNA | Application Note | Agilent Technologies | Review issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system. |
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| A Dilute-And-Shoot Method For Monitoring mAb PQAs From Spent Media | Application Note | By Erin Redman, Scott Mellors, Stephanie Klaubert, Scott Miller, and Graziella Piras, Repligen – PAT | Investigate an assay that measures monoclonal antibody PQAs from cell culture media, revealing charge and glycoform heterogeneity to streamline upstream processing. |
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QUALITY/ANALYTICAL METHODS SOLUTIONS |
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| Connect With Bioprocess Online: |
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