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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 Vadim Klyushnichenko, Ph.D., Calibr-Skaggs Institute for Innovative Medicines | Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies. | |
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| 2025 State Of Validation: Key Insights | White Paper | Kneat Solutions | Discover what’s driving change in validation in your industry in 2025 by exploring key Insights for a first look at this year’s top trends, challenges, and opportunities in validation. |
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| Evaluating The Expression Patterns Of Multiple Inhibitory Receptors | Application Note | By Mirko Corselli and Suraj Saksena, BD Biosciences | Discover how an innovative approach to interpreting T-cell exhaustion and inhibitory receptor expression is paving the way for innovative therapeutic approaches aimed at rejuvenating T-cell function. |
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| IVT mRNA Encapsulation Efficiency Assessment | Application Note | Agilent Technologies | In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. Discover how an analyzer system enhances encapsulation efficiency and critical quality attributes in IVT mRNA workflows. |
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| Reshaping Biotherapeutics Development At Johnson & Johnson | Article | Q&A With Dr. Marius Müller of J&J Innovative Medicine, NanoTemper Technologies, Inc. | Learn how innovative protein stability technology is providing deeper understanding and quality control for biotherapeutics within demanding, regulated pharmaceutical environments. |
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QUALITY/ANALYTICAL METHODS SOLUTIONS |
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| Why And Where To Monitor In Aseptic Processing Areas | Webinar | Particle Measuring Systems | Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value. |
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