Aspen Alert’s Post

Process Optimization and Economic Evaluation of Continuous Multi-Column Capture for Monoclonal Antibody – A Case Study Protein A affinity chromatography has been widely employed as the capture step for mAb purification and serves as a key driver of economic efficiency on downstream operations. To enhance the purification process and alleviate manufacturing constraints while reducing costs, continuous processing, such as multi-column capture (MCC), has gained attention. This study aimed to establish and optimize the protein A MCC process and to evaluate it with traditional single-column capture mode. Through a series of verification runs, it was determined that there was no significant difference in yield and quality attributes across different loops. Furthermore, annual cost of goods (COGs) was evaluated with the conventional single-column batch process. The results showed that MCC process reduced operation cost by 18% and almost doubled productivity in the specific scenario. https://lnkd.in/gbACvsCV #aspenalert #biotech #bioprocess

Key Takeaways of the fill-and-forget workflow with Wilson Wolf Manufacturing, LLC G-Rex and Bio-Techne reagents... - Slash manual interventions in T-cell manufacturing - Maintain excellent cell growth and phenotype - Optimize efficiency #celltherapy Learn more: https://lnkd.in/exFbaJMQ #immunotherapy #celltherapy #biomanufacturing

Exclusive application note preview for newsletter subscribers! Be among the first to receive our new downstream process of extracellular vesicles purification application note by subscribing to our newsletter: https://lnkd.in/eQJhe8z6 Extracellular vesicles are nanosized particles released by virtually all cell types in their environment. EVs are involved in cell-to-cell communication, and due to this role as natural biocarriers, EVs hold a potential role as drug carriers, therapeutic agents, and diagnostic tools. However, industrial-scale production of EVs requires technologies able to monitor the efficacy and efficiency of EV production and purification. We propose a Timegated® Raman spectrometer as an inline sensor to monitor a chromatography-based EV purification process. Our results suggest that the chemometric model based on Raman data can usefully monitor the purification process and discriminate between standard runs and runs in which the chromatography column was overloaded, or the starting material was spiked with impurities i.e. non-EV proteins. Find out more by subscribing to our newsletter! #timegating #processmonitoring #EVs #downstream #bioprocess #biotechnology

Exciting News! 🌟 Introducing Xtimate® Bio SEC – our cutting-edge chromatography column! Key Features: ✅ Effectively reduces nonspecific adsorption of biological samples. ✅ Successfully applied in the analysis of proteins, antibodies, and cytokines. ✅ Boosts selectivity and reliability in analytical testing. Upgrade your analyses with Xtimate® Bio SEC! Learn More: https://lnkd.in/gcTEcBf9 #LabLife #gradientelution #PHARMANEXT #PharmaIndustry #Innovation #pharma #DataQuality #labsoftware #HPLC #digitallab #UPLC #analyze #Column #chromatography #detection #solutions #chemical #biotech #extractions #resolution #industry #MaterialsScience #biotechnologyindustry #compounds #peakdrift #ExperimentSmart #spectroscopy #dataanalytics #Chemistry

New application note now available on Timegate's website! I am thrilled to share that our latest application note on the downstream process of extracellular vesicles (EVs) purification is now available: https://hubs.ly/Q02yXtqk0 Extracellular vesicles, nanosized particles released by virtually all cell types, are involved in cell-to-cell communication and have potential as drug carriers, therapeutic agents, and diagnostic tools. Industrial-scale production of EVs requires technologies able to monitor the efficacy and efficiency of EV production and purification. We propose using a Timegated® Raman spectrometer as an inline sensor to monitor a chromatography-based EV purification process. Key highlights: 🌟Advanced Monitoring: The chemometric model based on Raman data effectively monitors the purification process 🌟Quality Control: The model distinguishes between standard and compromised runs, identifying issues such as column overload or impurities Download the application note and read more! #timegating #processmonitoring #EVs #downstream #bioprocess #biotechnology

Efficiency meets precision with Eberbach’s E6145.00 Large Capacity Variable-Speed Orbital Shakers. Designed for rotary swirling action, these shakers handle loads up to 150 lbs, ensuring smooth mixing, particle suspension, and aeration. The balanced bearing plates and unique motion reduce stress on cells, making these shakers perfect for chromatography slurry preparation and cell cultivation applications. Elevate your scale-up fermentation and bio-processing with E6145.00's accurate control of orbital speed and time duration. Simple to use and maintain, these shakers guarantee a lasting, smooth operation. Learn more: https://lnkd.in/gfP3BPF4 #LabEquipment #Innovation #Eberbach #Bioprocessing #Pharmaceuticals #pharmaceutical #pharmaceuticalindustry #biotechnology #biopharma #pharma #biotech #science #researchdevelopment #research #researchanddevelopment #biochemistry #biochem #molecularbiology #chemistry #laboratory

Enhancing Biomanufacturing Efficiency: A Model-Based Plug-and-Play Hybrid Fed-Batch Process Using ATF Perfusion for High-Yield Drug Substance Production This study proposes a new single-step concentrated fed-batch process leveraging Alternating Tangential Flow (ATF) perfusion of the inoculum integrated to the production bioreactor to achieve high initial cell densities. A model-based approach was adopted to rationally optimize the process parameters. By integrating high seeding densities and optimized process strategies, this approach enhanced bioreactor efficiency and product yield by 4 to 6-fold (conventional 1.9 g/L to 10 - 12 g/L in intensified process), without compromising protein quality. The intensified process was further validated using different territory CHO cell lines and was found to yield similar results. An analysis of conventional fed-batch process to the new plug-and-play hybrid process suggested a 60 % reduction in costs, improvement in production efficiency, and consistent product quality, including post-translational modifications and glycosylation profiles. https://lnkd.in/g8RV2KQa #aspenalert #biotech #bioprocess

The SmartDip 220M: Manually retractable electrode housing. WATCH VIDEO Say goodbye to traditional measurement challenges and hello to unparalleled efficiency and accuracy in pH and dissolved oxygen (DO) monitoring. With the SmartDip 220M, precision and convenience go hand in hand. Key Features: 🔹 Manually Retractable Design: Enjoy hassle-free access to your pH electrode and DO sensor with the SmartDip 220M's intuitive retractable mechanism. No more downtime for sensor maintenance – simply retract, clean, and recalibrate in seconds! 🔹 Seamless Integration: Equipped with an Ingold connector our housing ensures seamless integration with your existing Ingold weld-in sockets. Other options such as Flange, Dairy and Triclover connectors goes with a wide range of applications, facilitating quick and secure connections for reliable measurements. 🔹 Robust Construction: Built to withstand harsh industrial environments, the SmartDip 220M boasts a durable construction that guarantees long-term performance and peace of mind. 🔹 Versatile Applications: Whether you're in pharmaceuticals, food and beverage, biotechnology the SmartDip 220M is your go-to solution for precise pH and DO monitoring in diverse applications. Incorporate the SmartDip 220M into your workflow and elevate your process control to new heights. From optimizing efficiency to ensuring product quality, our cutting-edge technology empowers you to achieve unparalleled results with confidence. Watch our video to see the SmartDip 220M in action and discover how it can revolutionize your pH and DO measurement processes. #SmartDip220M #pHmeasurement #DOsensor #ProcessOptimization #Innovation #ph #dissolvedoxygen #DO #retractable #sensor #processanalytics #pat #fda #processanalytics #processautomation #biopharmaceutical #biopharma #enzyme #biofertilizer #cellculture #microbiome #microbiology #pharmaceutical #bioreactor #fermenter #specialtychemicals #instrumentation #processengineering #dairyindustry #foodandbeverages #sugarindustry #api #activepharmaceuticalingredients

𝗠𝗶𝗹𝗹𝗶𝗴𝗿𝗮𝗺-𝗦𝗰𝗮𝗹𝗲 𝗶𝗰𝗜𝗘𝗙 𝗙𝗿𝗮𝗰𝘁𝗶𝗼𝗻𝗮𝘁𝗶𝗼𝗻: 𝗦𝗵𝗮𝗿𝗽𝗲𝗻𝗶𝗻𝗴 𝗜𝗻-𝗗𝗲𝗽𝘁𝗵 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗣𝗿𝗼𝘁𝗲𝗶𝗻 𝗖𝗵𝗮𝗿𝗴𝗲 𝗛𝗲𝘁𝗲𝗿𝗼𝗴𝗲𝗻𝗲𝗶𝘁𝘆 The CEInfinite icIEF fractionation system from Advanced Electrophoresis Solutions Ltd. (AES) significantly accelerates comprehensive insights into charge variant modifications during biopharma development, helping to mitigate costly setbacks related to scale-up and regulatory compliance. CEInfinite preparative icIEF is advancing the evolution of icIEF platforms by integrating cutting-edge instrument design, high-resolution critical reagents, and a standardized workflow. Its exceptional resolution in icIEF separation, paired with unmatched run-to-run repeatability for icIEF fractionation, guarantees superior performance with high throughput, purity, and yield. This enables effective solutions to stability, manufacturing, safety, and efficacy concerns. Utilizing custom-designed capillary cartridges offering ultra-high preparation capacity, the system effortlessly delivers milligram-scale yields within a week, facilitating detailed post-fractionation characterization. By integrating with LC-MS, IEX-MS, and MALDI-TOF, the CEInfinite system supports analysis at both the intact mass and peptide mapping levels. Additionally, its combination with SPR and potency assays further extends the application of icIEF fractionation into bioactivity studies. For more information about our icIEF fractionation advancements, please contact us at info@aeslifesciences.com. #biopharma #cief #charge heterogeneity #icief fractionation #LC-MS

The rapid growth projected for the global membrane chromatography market is a strong indicator of the increasing importance of this technology in biopharmaceutical production and downstream processing. The estimated 14.7% CAGR from 2024 to 2029 highlights how membrane chromatography is rapidly gaining adoption as an efficient and scalable alternative to traditional resin-based column chromatography. The rising demand for therapeutic monoclonal antibodies and other recombinant proteins is fueling investment in optimized purification technologies like membrane chromatography. As the biologics pipeline continues to grow, manufacturers will need flexible, high-throughput solutions.