BIA Separations Inc.

[Join us live] 🗓️ Join us on March 25th - 27th at the 2nd Annual DNA Process Development & Manufacturing Summit in Boston, where Matevž Korenč and robin PELIZZARI will talk about Optimization of plasmid DNA (pDNA) extraction via lysis to enhance manufacturing efficiency and quality. 💡Uncontrolled alkaline use and mechanical stress can degrade pDNA, and highly viscous solutions may cause heterogeneities or require extensive mixing, further compromising pDNA integrity. 𝗝𝗼𝗶𝗻 𝘁𝗵𝗶𝘀 𝗽𝗿𝗲𝘀𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻 𝗮𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗻𝘁𝗲𝘅𝘁 𝗼𝗳 𝘀𝗰𝗮𝗹𝗶𝗻𝗴-𝘂𝗽 𝗽𝗗𝗡𝗔 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 𝗳𝗼𝗿 𝗺𝗥𝗡𝗔 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀. Matevž and Robin will help you: ✔️comprehend the challenges associated with alkaline lysis in pDNA extraction ✔️ learn about an automated in-line lysis system with a closed single-use loop, tailored for process development up to pilot-scale within a GMP environment ✔️ explore at-line in-process control strategies tailored for managing complex crude lysis samples. ✏️ Register here: https://lnkd.in/drZGDmGN #pDNA #purification #biotech #mRNA 

[Product close-up] In recent years, the Orf virus (ORFV) has become a promising tool for protective recombinant vaccines and oncolytic therapy. 💡 Enhancing the purity of the final product, and consequentially, decreasing the negative impacts attributed to impurities is essential. 🚫 However, analytical methods available for characterizing ORFV components at various phases of production, including upstream and downstream processes are rather limited. 𝗛𝗣𝗟𝗖 𝗳𝗼𝗿 𝗢𝗥𝗙𝗩 For this purpose, we developed a high-performance liquid chromatography (HPLC) PATfix® analytical method, based on multiple-detector PATfix technology coupled with CIMac QA-0.1 (6 μm) analytical column, enabling us to assess sample composition at various stages of ORFV production and determination of ORFV particles. 📖 Read on: https://lnkd.in/dRhcHryg #ORFV #PATfix #downstream #upstream #therapy #vaccines

[Join us live] 🗓️ Join us from March 18th - 20th at the 8th Annual Bioprocessing Summit Europe in Barcelona or virtually, for Ivana Petrovic Koshmak, PhD’s presentation: Harnessing chromatography and ultracentrifugation breakthroughs for AAV capsid ratio assessment. This talk explores the use of the PATfix AAV Switcher to optimize AAV production and enable in-process monitoring during production batches. 💡 We will compare two bioreactor-scale production runs to assess upstream optimization’s effectiveness in reducing key impurities. 𝗘𝘅𝗽𝗮𝗻𝗱 𝘁𝗵𝗲 𝗣𝗔𝗧𝗳𝗶𝘅 𝘀𝘆𝘀𝘁𝗲𝗺 Additionally, we will discuss expanding the PATfix system with an ultracentrifugation (UC) module, offering a cost-effective and straightforward alternative to analytical ultracentrifugation for post-density gradient profiling of AAV materials. ✏️ Register here: https://lnkd.in/eXFxiENt #PATfix #biotechnology #biotech #bioprocessing #AAV

[Join us live] 🗓️ Join us on March 18th and 19th at the Advanced therapies 2025 conference, where Andreja Gamc Livk will present an anion-exchange (AEX) analytical method for characterizing and assessing the quality of AAV capsids. 𝗗𝗲𝗲𝗽 𝗶𝗻𝘀𝗶𝗴𝗵𝘁 𝗶𝗻𝘁𝗼 𝗔𝗔𝗩 This one-dimensional analytical method offers deep insights into AAV heterogeneity, providing high-resolution separation of full capsids across various sample matrices during the final stages of downstream processes (DSP). Additionally, a complementary chromatographic method has been developed to determine the percentage of AAV full capsids in upstream processes (USPs). 𝗖𝗮𝘀𝗲 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 𝗳𝗼𝗿 𝗯𝗲𝘀𝘁 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 In conclusion, we will explore through case studies how this combined analytical approach boosts AAV production, elevates AAV quality assurance, and ensures regulatory compliance. ✏️ Register here: https://lnkd.in/gBZjdrk #AAV #AEX #downstream #DSP #purification

[Improved performance] 🔎 𝗞𝗲𝘆 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲: effective and consistent separation of full AAV particles (containing the full recombinant DNA of the gene of interest) from non-functional capsids. 💡This study presents the high reproducibility, homogeneity and scalability of CIM QA HR chromatographic monoliths by implementing a chromatographic AAV2/8 empty-full separation method as one of column release test methods in the production of CIMmultus QA HR monolithic line. 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗔𝗔𝗩 𝗗𝗦𝗣 We found that batch-to-batch and scale-to-scale reproducibility of the chromatographic material is crucial to achieve enhanced robustness of AAV downstream processing. 📖 Read on: https://lnkd.in/dhaUQFSP #AAV #DNA #monoliths #downstream

[Join us live] 🗓️ Join us on March 11th and 12th at the Applied Biophysics Forum in Drug Delivery 2025 in Mainz, Germany. The Applied Biophysics Forum in Drug Delivery 2025 focuses on advanced biophysical characterization of mRNA and other nucleotide therapeutics. That's why Tristan Kovačič and Mojca Tajnik Sbaizero will be presenting two posters:  1️⃣ Monolithic columns for high recovery purification process of RNA-LNP vaccines and therapeutics 2️⃣ A chromatographic tool to comprehensively characterize complex novel RNA-LNP drug products Don’t miss a chance to meet and discuss! ✏️ Register here: https://lnkd.in/dtE6-CTV #mRNA #purification #therapeutics #biotech

[Join us live] 🗓️ Join us on March 4th and 5th at the Vaccines world summit 2025 in India, where Marko Narobe will present his poster “Design of experiments for lentiviral downstream process optimisation using CIM® QA 0.05 mL monolithic 96-Well plates.” 𝐒𝐚𝐥𝐭 𝐜𝐨𝐧𝐜𝐞𝐧𝐭𝐫𝐚𝐭𝐢𝐨𝐧 𝐦𝐚𝐝𝐞 3𝐱 𝐭𝐡𝐞 𝐝𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐜𝐞 🔎Using DoE, we successfully increased infectious lentiviral recovery to 70%, a 3x increase, compared to initial results. 💡Interestingly, salt concentration in loading sample was determined as the most important factor for high infectious recovery of lentivirus from CIM QA column. ✏️ Register here: https://lnkd.in/d8veZybv #vaccines #doe #downstream #purification #monoliths #biotech

[Improved performance] The need for efficient large-scale pDNA production processes with high purity and productivity is on the rise.📈 ⛔But chromatographic purification of pDNA is often a bottleneck due to low dynamic binding capacities (DBC), pDNA recovery and/or low selectivity of columns.  𝐈𝐧𝐜𝐫𝐞𝐚𝐬𝐢𝐧𝐠 𝐭𝐡𝐞 𝐝𝐲𝐧𝐚𝐦𝐢𝐜 𝐛𝐢𝐧𝐝𝐢𝐧𝐠 𝐜𝐚𝐩𝐚𝐜𝐢𝐭𝐲  ↗️The ultimate goal of our investigation was to increase the DBC for pDNA on a monolith stationary phase by grafting the surface with linear polymethacrylate brushes (grafted chains), while retaining high pDNA recovery and chromatographic selectivity between pDNA and RNA impurities. 𝐓𝐡𝐞 𝐭𝐞𝐬𝐭 🔎We have prepared a series of columns differing in length and density of grafted chains and tested them for pDNA capture. 📖Read on: https://lnkd.in/dwAmGge9 #pDNA #RNA #chromatography #purification

[Join us live] 🗓️  Join our webinar on February 27th, to learn about AAV capsid analysis and quantification with chromatography and ultracentrifugation-based techniques. Andreja Gramc Livk and Sebastijan Peljhan will explore empty-to-full AAV capsid ratio determination using multimodal detection techniques in combination with improved anion exchange (AEX) chromatography methods and post-ultracentrifugation density gradient profiling. 𝐖𝐚𝐭𝐜𝐡 𝐭𝐡𝐞 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐭𝐨 𝐥𝐞𝐚𝐫𝐧 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭: ✔️ applying different elution strategies for the baseline separation of empty and full capsids. ✔️ distinguishing capsid subspecies based on spectroscopic differences in capsid composition. ✔️ using a light scattering detector for selective analysis of samples with complex matrices and achieving sensitive detection of low-concentration capsid subspecies with fluorescence detector. ✔️ understanding how post-density gradient ultracentrifugation profiling offers a more affordable and straightforward alternative to analytical ultracentrifugation, eliminating the need for expensive equipment and complex data analysis. ✏️ Register here: https://lnkd.in/drs3gRhS #AAV #purification #chromatography #biotech #dataanalysis

[New product] 🔎 The alkalizator is a fully automated in-line lysis system designed for process development up to pilot scale, featuring a closed single-use loop and state-of-the-art mixing control. 𝐌𝐨𝐫𝐞 𝐩𝐃𝐍𝐀, 𝐥𝐞𝐬𝐬 𝐢𝐦𝐩𝐮𝐫𝐢𝐭𝐢𝐞𝐬 ⬆️⬇️ The in-line alkaline lysis system is designed to increase control and efficiency of pDNA isolation from bacterial cells, while decreasing unwanted impurities such as host cell genomic DNA and RNA. 𝐓𝐡𝐞 𝐭𝐨𝐰𝐞𝐫 𝐚𝐧𝐝 𝐭𝐡𝐞 𝐫𝐞𝐚𝐜𝐭𝐨𝐫 The system includes the lysis reactor, a single-use component with a fixed volume of 1000 mL or 5000 mL, and the alkalizator tower, which serves as the controller unit with user-friendly software. 𝐒𝐭𝐚𝐭𝐞-𝐨𝐟-𝐭𝐡𝐞-𝐚𝐫𝐭 𝐦𝐢𝐱𝐢𝐧𝐠 𝐜𝐨𝐧𝐭𝐫𝐨𝐥 Together, they can process up to 500 L of resuspended cells per workday, ensuring efficient and safe operations. 💪 📖 Learn more: https://lnkd.in/dCHRcchM #pDNA #RNA #DNA #purification #biotech