INSIGHTS ON DOWNSTREAM MANUFACTURING
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![GettyImages-1371707479-lab-mask-team-partnership]( "Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products")
Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug ProductsDrug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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![MCC vs batch]( "How To Select Your DSP Chromatography Technology")
How To Select Your DSP Chromatography TechnologyWatch to explore the differences between the conventional single-column batch method and the multi-column approach for mAb capture.
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![Quality control assurance satisfaction-GettyImages-2117357383]( "Enhancing Process And QC For Multi-Column Chromatography")
Enhancing Process And QC For Multi-Column ChromatographyExplore two innovative technologies that address major purification challenges in DSP: continuous multi-column chromatography and advanced chromatography or liquid chromatography-mass spectrometry.
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![mAbs GettyImages-1441786721]( "De-Bottlenecking The UF | DF Steps — Enhancing Recovery And Efficiency In Continuous Downstream Processing")
De-Bottlenecking The UF | DF Steps — Enhancing Recovery And Efficiency In Continuous Downstream ProcessingThis study introduces an innovative flat sheet membrane device designed for TFF. Explore findings, including UF and DF data, to see how this new approach supports continuous biomanufacturing processes.
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A Standardized Gloveless Robotic Isolator10/16/2024
By eliminating human intervention—the primary risk factor compromising drug sterility and quality—gloveless aseptic processing technology offers manufacturers greater flexibility, safety, and regulatory compliance in their filling operations.
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Vial Fogging: Practical Considerations For Vial Selection10/16/2024
Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.
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Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability10/16/2024
Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.
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Support Of Scale-Up And Technical Transfer Through Understanding Equipment10/16/2024
See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.
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Process Development For Lyophilized Products10/16/2024
Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
DOWNSTREAM MANUFACTURING SOLUTIONS
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![Entegris]( "Mixing Systems: Complete Recirculation And Mixing Process System")
The Entegris mixing system is designed to maximize simplicity, ease-of-use, and affordability. This single-use bag system creates a completely sterile mixing and recirculation process from start to finish.
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![Process Intensification Solutions for mAb Bioprocessing]( "Driving Innovation And Performance While Reducing Cost Of Goods")
DurA Cycle A50 aims to maximize productivity and improve process economics. The protein A resin improves purification performance with high capacities and provides a wider elution pH window.
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![GettyImages-2166607928_aseptic fill finish]( "Aseptic Fill Finish")
Our comprehensive inspection systems, designed to adhere to the strictest regulatory standards, offer robust quality assurance, safeguarding the integrity of your product from development through to market.
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![Buffer and Balanced Salt Solutions]( "Buffer And Balanced Salt Solutions")
Critical in almost every step of viral vector and gene therapy manufacturing processes as well as fundamental aspects of cell therapy process development, buffers are essential tools enabling optimization of vector stability, transfection efficiency, safety, targeting, and regulatory compliance.
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![Cytiva Flex Factory]( "Process Trains For Flexible, Configurable Biopharma Manufacturing Capacity")
Transform your space to fit your needs
Configurable FlexFactory™ biomanufacturing process trains can help scientists better control the production and processing of different viral vectors and new modalities—all within the same space. Plan your agile manufacturing strategy with greater efficiency and integration to address current and future capacity needs.
