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| Webinar: Navigating Global Regulatory Landscapes in an Evolving Biopharma Industry | This webinar offers insights into managing raw material changes and navigating regulatory challenges in the biopharma industry. Experts will discuss collaboration between suppliers and users, risk management, change management, and adapting to evolving regulations. Key objectives include mastering regulatory guidance, implementing effective change management, and understanding market trends. Join us to explore best practices and remain compliant throughout drug development. Click here to learn more. |
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FOCUS ON QUALITY/ANALYTICAL METHODS |
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By Christian Gausepohl, Ph.D. | Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations. | |
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| Cell-Based Assays For Immuno-Oncology | e-book | Lonza | Cell-based immunotherapy leverages immune cell types that can fight cancer due to their ability to recognize and activate to kill cancer cells. Explore the impact of immunotherapy on cancer treatment. |
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| Multicolor Flow Cytometry Panel Design | Video | BD Biosciences | This series of videos on multicolor flow cytometry panel design offers a deeper understanding of the fundamentals of panel design as well as various strategies to streamline panel design. |
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| Logical Scale Out Before Scale Up | Article | RoosterBio | Explore how synthetic biology and a "scale-out" biomanufacturing strategy can unlock "infinite diversity in infinite combinations," optimizing MSC functionality for superior outcomes. |
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| A Successful Transition To cGMP Manufacturing | Webinar | Lonza | Explore the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development. |
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QUALITY/ANALYTICAL METHODS SOLUTIONS |
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| The debate rages on. While the automation that enables continuous processing gets a lot of hype, there are plenty of dyed-in-the-wool biopharma pros who contend that process optimization and intensification yield comparable benefits, without requiring the capital-intensive process overhaul that continuous demands. Join Bioprocess Online Live for a virtual deep dive into the scalability, sustainability, and capital implications of the continuous-versus-optimized debate. Registration is free thanks to the support of Cytiva. |
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| Why Perform A D-Value Study? Reference Review | Article | Mesa Laboratories | Understanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies. |
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| Real-Time Facility Monitoring For Quality And Compliance | White Paper | TSI Incorporated | As particle counting instruments evolve, opportunities to implement real-time quality control strategies arise, enabling the reliable production of high-quality drugs without excessive regulatory oversight. |
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| Connect With Bioprocess Online: |
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