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Filtration & Chromatography
Special Report

Simplifying Downstream Processing: Innovative Solutions for Filtration and Chromatography


Special Reports

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UFDF is a critical step in the downstream process that commonly uses tangential flow filtration (TFF) techniques. Traditional UFDF relies on mass-balance monitoring, which presents challenges such as variability across runs and the need for frequent sampling. As the demand for high-concentration monoclonal antibody (mAb) drugs rises, there's a growing pressure to optimize processes while maintaining critical quality attributes. Process Analytical Technology (PAT) offers a solution by enabling real-time protein concentration monitoring using ultraviolet-visible (UV-vis) spectroscopy through Variable Pathlength Technology (VPT). The KrosFlo FS-15 TFF system, incorporating VPT technology, allows for proactive control based on immediate concentration feedback, enhancing process efficiency and product quality. Through experimental validation across a range of high-concentration products, this approach demonstrated significant improvements in process control, reducing errors, and ensuring consistent quality thr...

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Microbial expression systems are crucial in developing innovative medicines and expanding development pipelines due to the broad range of molecule formats that can be obtained using this technology. However, this approach can be challenging as it requires a variety of manufacturing processes to handle these diverse molecule formats. This is where collaboration with an experienced organization comes into play. Boehringer Ingelheim, known for its proficiency in this technical domain, has a proven track record with 19 commercial microbial products and successful audits and regulatory compliance. The company's commitment to quality and flexibility in implementing production processes make it a reliable partner. Its technology-platform neutrality also simplifies technology and process transfers. Fill out the form below to read the full report.

Ask the Expert Webcasts

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This webcast features: Lucas Smith, Commercial Project Manager, TFF Systems, Repligen. The latest in TFF system innovation by Repligen is coming… Get an inside look into a new purpose-built single-use TFF system designed for process development and CGMP production of mRNA, gene therapies, and personalized medicine. While much of the equipment that is being leveraged for these applications today is repurposed from applications supporting significantly larger volume ranges, this system truly satisfies the demand for smaller scales. With unique features including complete end-to-end automation and real-time concentration measurement, this TFF system may be exactly what you need to produce your next blockbuster drug. Key Takeaways: Just fill out the form below to watch the recorded webcast now.

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This webcast features: Artur Stanczak, Field Application Specialist, Process Chromatography, Bio-Rad Laboratories. Large molecule purification presents significant challenges due to their considerable size. For instance, Immunoglobulin M (IgM) molecules, ranging from 900 to 1,000 kD, play pivotal roles in mammalian immune responses and find extensive applications in diagnostics and therapeutics. Purification of such molecules is particularly intricate owing to several factors including their weak Protein A binding sites, limited dynamic binding capacity, and slow diffusion rates. Moreover, IgMs exert notable effects on chromatographic purification processes. Their inability to penetrate small pores necessitates higher pore volume utilization, resulting in sluggish diffusion and mass transfer kinetics within traditional chromatography resins. Consequently, this diminishes binding capacity and resolution, thereby complicating purification efforts. This webinar will delve into innovative strategies to sur...