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| Multispecific molecules bring added complexity to downstream purification—think incorrect chain pairings, aggregation, fragmentation, and lower yields. Join Bioprocess Online Live as we explore how developers are addressing these challenges to achieve high purity and efficient processes. Gain insights into key considerations for downstream teams when designing purification strategies for these advanced biologics. Registration is free thanks to the support of Thermo Fisher Scientific. |
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FOCUS ON FACILITIES DESIGN & MAINTENANCE |
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By Tyler Menichiello, contributing editor | This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld. | |
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| The Problem With Construction Quality | White Paper | By Rich Tree, CAI | Hundreds of issues plague data center commissioning, mostly due to construction errors. Discover how a shift from quality assurance to robust quality control can prevent costly rework. |
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| Poking And Prodding The Molecules Of Life | Article | Mad City Labs, Inc. | Using advanced biophysical techniques, researchers have shed light on the dynamic behavior of individual biomolecules, driving breakthroughs in our understanding of life's molecular intricacies. |
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| Vaporized Hydrogen Peroxide (VHP) Resistance Testing | Application Note | Particle Measuring Systems | Explore test results demonstrating the suitability of a robust microbial sampler for environments where frequent exposure to harsh cleaning and sterilization methods, like VHP in isolators, is routine. |
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| Tips For Designing A Single-Use Manifold For Advanced Therapies | Article | By Jay Collins and Chris Hofmann, Charter Medical | Expert single-use engineers address six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids. |
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FACILITIES DESIGN & MAINTENANCE SOLUTIONS |
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| The biotechnology sector is transforming with AI, automation, and digitalization playing key roles in drug development and manufacturing. As the industry moves toward end-to-end digitalization, don't miss the opportunity to join the 2025 ISPE Biotechnology Conference, 2 – 3 June in Boston, Massachusetts, USA, and virtually, to gain a holistic perspective on how to view and apply digital transformation in biopharmaceutical manufacturing. Register today: visit ISPE.org/Bio25. |
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FOCUS ON MANUFACTURING CONTROLS |
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| Leveraging AI To Build Process Intelligence | Article | By Unjulie Bhanot, IDBS UK HQ | Accelerate drug development with AI. Enhance process intelligence and achieve gold-standard data sets with the right digital tools and improved maturity. |
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| Mastering Technology Transfers: Our Blueprint For Success | White Paper | By Dr. Holger Gerlach, Boehringer Ingelheim Biopharmaceuticals GmbH | Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market. |
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| Data Modeling Best Practices And Pitfalls For Pharma 4.0 | Article | By Aron Semle, HighByte | Explore best practices that serve as a guideline for commonly encountered data modeling challenges and how life sciences manufacturers can overcome them by leveraging an Industrial DataOps solution. |
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| Pushing Boundaries In Biophysics And Biomanufacturing | Article | A conversation with Marius Müller, Ph.D., Johnson & Johnson Innovative Medicine, NanoTemper Technologies, Inc. | Gain valuable perspectives on the future of biomanufacturing, including the impact of data science, automation, and continuous learning, shared by an experienced biophysics specialist in the field. |
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MANUFACTURING CONTROLS SOLUTIONS |
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