Posters
116 items
2023
Comparability Study Between Ion-Exchange Monolith and Affinity Resin For Purification of AAV8
The main objective of every downstream process (DSP) for AAV is to achieve high recovery while delivering the purest, most potent product possible. The capture step in AAV gene therapy...
Targeted Optimization of AAV8 Upstream Process for Enhanced Downstream Performance
Several recombinant AAV (rAAV)-mediated therapies have been approved so far, and many more are in clinical trials, yet developing an efficient rAAV process platform remains a challenge. First obstacle arises...
Improvement of Empty | Full Resolution by Implementation of Novel Eluents Using PATfix
In every adeno associated virus (AAV) downstream process the key steps are the enrichment of full capsids and the in-process empty/full analytics. A common approach for enrichment of full capsids...
Chromatographic Platform for Characterization of mRNA Samples
mRNA has been at the forefront of both scientific and general public interests from the start of the COVID-19 pandemic. However, there are still limited options available for rapid characterization...
Implementing Chromatographic Methods for Evaluation of Large Scale Monolithic Columns for AAV Capsids Separation
Quaternary amine (QA) modified monolithic columns are frequently used for purification of therapeutically relevant adeno-associated virus (AAV) vectors, used in gene therapy. Beside process- and sample-derived variability, chromatographic material variability...
Role of Plasmid DNA Isoforms During Anion Exchange Chromatography
New development in the modern biotechnology increased the need for plasmid DNA (pDNA) with sizes above 10 kbp (large pDNA), but their chromatographic purification is often challenging due to low...
Gram-Scale mRNA Production Using a 250-mL Single-Use Bioreactor
The cost of mRNA production is driven by IVT reagents, particularly the co-transcriptional capping reagents. Optimization of mRNA yield is therefore crucial for lowering the cost of mRNA production. To...
Characterization of EVs Subpopulations From CIMmultus EV Using PATfix System
Cells release extracellular vesicles (EVs) of different sizes and intracellular origin. Due to their heterogenicity, the isolation of the target EV population from a mixture of supernatant-derived particles can be...
Purification of Newcastle Disease Virus Produced on a Novel Avian Cell Line CCX.E10
Newcastle disease virus (NDV) from the Paramyxoviridae family is a single-stranded, negative-sense, enveloped RNA virus of avian origin. There are many commercial vaccines based on live or inactivated virions that...
Monolithic Columns as Downstream Processing Solutions for Lentiviral Purification
Lentiviral vectors are efficient tools for transfer and stable integration of large gene inserts into the genomes of both dividing and non-dividing cells. Third generation of lentiviral vectors, which uses...
2022
A PATfix® Analytical Method for Adenovirus Sample Characterization in Upstream Process Development
Adenovirus is well-know gene therapy tool that gained attention as a promising vaccine delivery vehicle, specially during Covid-19 pandemics, where it was used to deliver sequence for protein S (S)....
Optimization of Upstream Extracellular Vesicle Processes Using PATfix® Analytical Tools
Extracellular vesicles (EV) are lipid bound products secreted by cells. Among them, exosomes have great potential for clinical applications. Animal and human-derived components used in cell culture, such as fetal...
Application of PATfix® Valve Switch Analytics in Media Screening for AAV8 Production
Recombinant adeno-associated viral (rAAV) vectors are the leading gene delivery tool for treatment of a variety of diseases. While several rAAV mediated therapies have been approved so far, and many...
HEK293-Derived Adeno Associated Virus (AAV) Purification | Comparison of Small Scale Laboratory Production Towards Industrial Format Using Monoliths
During recombinant adeno associated virus (rAAV) downstream processing, a large amount of host-cell and product related impurities needs to be removed from the product. Successful process on laboratory scale, such...
Adeno Virus Vector Manufacturing Platform Using CIMmultus QA Column to Produce Safer Vaccines Cheaper
Adenovirus has after two decades gained new consideration and is now used as a COVID-19 vaccine delivery vehicle. To reduce side effects of the vaccine it’s purity is of utmost...
Sample Displacement Chromatography for High Purity of Supercoiled DNA Plasmids
Sample displacement chromatography (SDC) is a chromatographic technique that utilizes differences in relative binding affinities of components in a sample mixture under chromatographic conditions. Here, we use SDC approach with...
Increasing the Productivity of IVT Reaction With HPLC Analytics
The cost of mRNA production is driven by IVT reagents, particularly the capping reagent. Optimization of mRNA yield is therefore crucial for lowering the cost of mRNA production. In order...
Scalable mRNA Purification Using PrimaS Multimodal Chromatography
CIM PrimaS column family combines multimodal anion exchange/hydrogen bonding properties, binding molecules with predominantly negative charge. It is used as capture method for purification of mRNA from IVT (in-vitro transcription)...
Production Scale up of SDVB Monolithic Columns for the Purification of mRNA Molecules
Messenger RNA (mRNA) is becoming a major contributor in the fields of gene therapy and vaccines, including those developed in response to the COVID-19 pandemic. Convective Interaction Media (CIM) Styrene...
Monitoring mRNA Production Using CIMac Oligo dT Analytics
mRNA has been at the forefront of both scientific and general public interests from the start of the COVID-19 pandemic. The demand for the mRNA product has been incredible for the...
Effect of Matrix and Electrophoretic Conditions on Analysis of Linear pDNA
Agarose gel electrophoresis (AGE) analysis is an important method for monitoring of plasmid DNA (pDNA) quality, with ability to separate pDNA isoforms (sc, oc, lin, multimer). Plasmid linearization can be...
Influence of Chromatographic Parameters on Empty | Full AAV Separation
Monoliths are commonly used for separation of empty and full AAV capsids on analytical and preparative scale. PrimaS approach for AAV separation employs an ascending pH gradient, which can be sensitive...
Characterization of Various AAV Subpopulation Species, Separated by Multimodal Column PrimaT
In each adeno associated virus (AAV) downstream process one of the key steps is enrichment of full capsids. This could be achieved by density gradient ultracentrifugation however a main drawback...
2021
Separation of Empty and Full AAV Capsids by Multimodal Metal Affinity Chromatography
Removal of empty capsids is a particular goal of AAV purification. Multimodal PrimaT ligand offers new options for removal of empty and also damaged capsids. Besides it also contributes to...
Combining the Sensitivity of the PATfix Platform With the Resolution of Ultracentrifugation for AAV Characterization
Density gradient ultracentrifugation (DGUC) is a well established tool for Empty/ Full AAV capsid separation based on density differences between AVV sub-populations. However DGUC practice is laborious and lacks any...
Using PATfix Analytical Platform to Optimize Lysis Conditions in pDNA Downstream Processing
Optimizing processing steps in sc pDNA isolation is critical for obtaining good process yields as well as high product purity. PATfix platform with convective chromatography media (e.g. monolith) offers a...
CIM PrimaT | New Multimodal Ligand for Separation of Empty and Full AAV9 Capsids
AAV9 clarified harvest from Sf9 cells was concentrated and purified using combination of tangential flow filtration, nuclease treatment and cation exchange capture. First part was TFF coupled with Kryptonase treatment....
Two-Step Chromatographic Purification of pIVTeGFP-Transcribed mRNA With Post-transcriptional Capping
In mRNA production process, downstream purification of in vitro transcription (IVT) reaction often relies on precipitation methods which cannot provide resolution, recovery, or reproducibility to consistently produce a safe and...
High Yield mRNA Production Process From E. Coli to Highly Pure mRNA
The recently demonstrated efficacy of mRNA-based Covid-19 vaccines has shown promise of this therapeutic format, but also highlighted the need for higher efficiency of mRNA production to meet enormous needs...
2020
CIMmultus Oligo dT Affinity Column Based Extraction of mRNA From IVT Mixtures
The increasing demand for messenger RNA (mRNA) as a therapeutic product requires larger production scales and more efficient extraction techniques. In this poster, fast and efficient way to purify poly-adenylated...
Preparation of Linear Plasmid DNA for in Vitro Transcription Reaction
Linearised pDNA is currently the starting point of In-Vitro-Transcription processes to synthesize mRNA. Large scale purification protocols for manufacturing of pDNA used for Gene Therapy applications typically include two chromatography...
2018
Isolation of RAE-1 From Murine Cells Based on Immunoaffinity Monolithic Chromatography
Immunoaffinity columns using antibodies as ligands against mammalian proteins could be used for different applications in protein expression control and, if a standard available, for direct protein quantification in complex...
One-Step Monolith Purification of Oncolytic Influenza Virus Produced in Vero Cells
Chromatography is a useful purification method for large biomolecules and virus manufacturing and it is easily scalable to large production volumes. Convective Interaction Media (CIM) monolithic columns constitute of large...
Chromatographic Monoliths With Hydrazide Modified Surface | New Member of CIM Family
Hydrazide-activated (HDZ) columns were proven to be a product of choice for making the most effective immunoaffinity columns. They take advantage of a special hydrazide linkage that binds antibodies through...
Purification and Analytics of pDNA Using Hydrophobic Monoliths in Sample Displacement Mode
CIM chromatographic monoliths enable high 1) productivity of pDNA downstream process (DSP) due to high dynamic binding capacity for pDNA in small elution volumes and short chromatographic runs; 2) high...
2016
Chromatographic Separation of Full and Empty AAV8 Capsids
Adeno-associated virus (AAV) vectors of various serotypes are considered to have high potential for gene therapy applications. Currently, manufacturing of AAV vectors faces the challenge of co-production of incompletely formed...
Chromatographic Performance of Novel Polymetacrylate-Based Ion Exchanging Monoliths
Productivity of the downstream bioprocessing depends among others on the efficiency of chromatographic step. One of the crucial chromatographic parameters is dynamic binding capacity (DBC) for certain biomolecule. DBC could...
Optimizing a Separation of IgG Charge Variants Using Weak Cation-Exchanging Analytical Monolithic Column
The upstream and downstream monoclonal antibody (mAb) bioprocessing makes them susceptible to physical and chemical modifications. In the biotechnological production process of mAbs, structural variations may arise due to some...
Optimization of pDNA Downstream Bioprocessing Using Hydrophobic Monoliths in Sample Displacement Mode
Since plasmid DNA (pDNA) as a pharmaceutical product has stringent requirements of purity and efficacy, one or more chromatographic steps are often used in the downstream processing train. High ligand...
Large Volume CIM Chromatographic Monoliths – Scalability and Uniformity
To ensure the desired chromatographic characteristics of the CIM® monolithic column at large scales, monolith microstructure morphology, pore size distribution, porosity and surface ligand density should be uniform. To demonstrate...
Immunoaffinity Columns | Reproducible and Reliable Tool for Analytics and Purification
There are many cases, where a single protein needs to be purified from a complex sample. Such proteins manifest themselves as impurities, which can affect further analysis, either by causing...
2015
Overcoming the Limitations of Large Scale Polymerization
Methacrylate monoliths (CIM monolithic columns) allow for very fast and efficient separations and exhibit very high binding capacities for extremely large bio-particles due to their large inner channel diameters and...
Preparation of Immunoaffinity Columns for Purification and Analytics of MULT-1 and RAE-1
Immunoaffinity columns using antibodies as ligands against mammalian membrane proteins could be used for different applications in protein expression control and, if a standard available, for concentration determination. Additionally these...
2014
Testing Different Activation Chemistries for IgG Immobilization Onto a Monolithic Support
Interactions between antibodies and their antigens are highly selective and therefore immensely popular for affinity chromatography. Consequently, numerous antibody immobilizations were performed on monolithic supports via different activation chemistries in...
Quantitative HPLC Determination of IgM in Cell Supernatant on CIM OH Column
Monolithic ion exchange CIM (Convective Interaction Media) columns have been proven in quantitative analysis of different immunoglobulins such as IgM and IgG from human plasma or cell supernatants. The separation...
Development of Methacrylate Monolithic Columns for Depletion of Human Serum Albumin (HSA)
Biological samples often consist of a main component, such as albumin in serum, and many other constituents, present in smaller quantities, but nevertheless of high importance in biological systems. When...
Development of a Separation Method for Exosomes by Means of Large Pore Monolithic Columns
Exosomes are nano-sized vesicles that are released by many different cell types. They are involved in the transport of a wide range of signalling molecules, including mRNA, microRNA and proteins....
Characterization of Chromatographic Monolithic Columns With Different Hydrophobicity
Surface hydrophobicity/hydrophilicity of chromatographic stationary phases is one of the important characteristics that influence the chromatographic column performance. On the one hand, the surface should be highly hydrophilic to avoid...
Analytical Method for Plasmid Isoform Separation Using Histamine Modified Monolithic Columns
One of the major requirements for pharmaceutical-grade pDNA is its high homogeneity, being mostly in supercoiled (sc) isoform. Chromatographic separation of sc pDNA from open coiled (oc) or linear isoform...
Introduction of PAT to Improve the Efficiency and Robustness of Vaccine Development and Manufacturing
Challenges in monitoring the quality of vaccine production • Process Analytical Technology (PAT) ensures process reproducibility in bioprocessing • A mechanism to design, analyze and control pharmaceutical manufacturing processes through...
Purification of Staphylococcus Aureus Bacteriophages VDX-10 Using CIM Monolithic Columns
In recent years bacteriophages were identified as a useful potential tool for different applications such as alternative to antibiotics, detection of pathogenic bacteria, delivery vehicles for protein and DNA vaccines...
Using Fingerprint HPLC Method to Develop and Control IgG (IVIG) From Cohn (I+II+III) Paste Production Process
The demand for human immunoglobulin is invariably increasing on an annual basis. To satisfy demands, different manufacturing processes are used to isolate immunoglobulins from human plasma. A quest for alternative...
CIMac Analytical Columns for In-Process Control of Adenoviruses
Determining the concentration of viruses is a crucial step in any production process. The most commonly used methods for virus quantification are either based on the infectivity of the virus...
Development of TiO2-Coated Monolithic Columns for Phosphopeptides Enrichment
Phosphoproteomics is a branch of proteomics that focuses on deriving a comprehensive view of the extent & dynamics of protein phosphorylation by way of identifying & characterizing proteins that contain...
Other
Optimization of Preparative-Scale mRNA Capture Using Small-Scale Oligo dT Affinity Monoliths
Optimize mRNA dynamic binding capacity using CIMmic Oligo dT discs, which couple oligo-deoxythymidilic acid probes to monolith surfaces for selective mRNA binding. This study highlights the reduction in sample consumption and increased DBC from 1.9 mg/mL to 6.8 mg/mL through flow rate and buffer composition optimization, making CIMmic discs invaluable in early development.
Modulating and Understanding Retention of Proteins on Chromatographic Support by Changing Cation-Exchanging Ligand
This study compares protein separation using CIM SO3 and CIM SO4 monolith cation exchangers, highlighting differences in elution under an ascending salt gradient. Through thermodynamic analysis, it explores how sulfonate and multimodal sulfate ligands affect retention and adsorption of lysozyme and cytochrome c, demonstrating CIM SO4's enhanced selectivity and potential as a tool for challenging protein separations.
Accelerating AAV Processing: Scalable, Serotype-Agnostic Process Eliminating 2-steps (DNase and TFF) and Optimized for Physiological-Like Conditions
This study proposes a streamlined alternative to traditional AAV downstream processing, focusing on reducing the number of steps while simultaneously improving both recovery and process efficiency. We demonstrate a novel approach comprising just five integrated steps shown to work on various serotypes (AAV2, AAV8, AAV9).
Efficient Removal of Activated Coagulation Factor XI (FXIa) from Cohn Fraction II Paste Using Mixed Mode Ligand
Factor XI (FXI) is the zymogen of a serine protease, Factor XIa (FXIa). It is a 160 kDa protein, with an average plasma concentration of 3 to 7 µg/ml. Its...
Monolith Based Chromatography Is a Suitable Tool to Prepare and Analyze E. coli – Outer Membrane Vesicles
Explore the collaborative study with NecstGen on developing a scalable, GMP-ready DSP platform for lentiviral vector (LV) gene therapies. Utilizing Sartorius BIA Separations' CIM QA and DEAE Monolithic 96-well plates and CIMmultus QA columns, the study achieved significant improvements in DSP yields, reducing manufacturing costs. Discover how Design of Experiments (DOE) methodologies enhanced process understanding and LV recovery, optimizing purification efficiency and product quality for cost-effective gene therapy solutions.
Collaborative Development with NecstGen: Scalable GMP-Ready LV DSP Platform
Explore the collaborative study with NecstGen on developing a scalable, GMP-ready DSP platform for lentiviral vector (LV) gene therapies. Utilizing Sartorius BIA Separations' CIM QA and DEAE Monolithic 96-well plates and CIMmultus QA columns, the study achieved significant improvements in DSP yields, reducing manufacturing costs. Discover how Design of Experiments (DOE) methodologies enhanced process understanding and LV recovery, optimizing purification efficiency and product quality for cost-effective gene therapy solutions.
PATfix® pDNA Platform and PCR Methods as Orthogonal Analytical Tools for Quantification of pDNA
Poster presents a comparison of three orthogonal methods—PATfix® pDNA Platform, qPCR, and dPCR—for the quantification and characterization of plasmid DNA (pDNA) in gene therapy workflow. While PCR-based approaches provide total...
Monitoring Orf Virus Production with PATfix® Analytical Method
Orf virus (ORFV) is a promising vaccine vector candidate, capable of inducing a strong, long-lasting immune response without integrating into the host genome. Its broad host range and ability to...
Optimizing AAV Purification: Comparative Evaluation of Three CIMmultus® Polishing Columns for Enhanced Vector Enrichment and Final Product Purity
The poster presents a comparative evaluation of three CIMmultus® polishing columns—QA HR, PrimaT, and PrimaS—in optimizing the purification of AAV vectors. Highlighting their unique strengths, the study reveals QA HR's...
High Throughput Screening (HTS) or Single-Column Approach for Improvement of Empty/Full Separation of AAV
Accelerate AAV development with a fast, reproducible polishing workflow that separates empty and full capsids across three scalable CIM® monolith formats - from 96 well plates to CIM® Octa and...
Enhanced Monitoring of AAV Downstream Processes Using Liquid Chromatography Approaches
In-process control of AAV downstream processes (DSPs) ensures process efficiency, product quality, safety and consistency . Using liquid chromatography (LC)-based methods such as size exclusion chromatography (SEC), cation exchange (CEX),...
Advancements in Lentiviral Purification: From High Throughput Screening to Scalable Solutions
Lentiviral vectors are being increasingly used as tools for stable integration of large gene inserts into the genomes of both dividing and non-dividing cells. With 3rd and 4th generation of...
Integrating Upstream and Downstream Processes for Enhanced Purity and Yield of Adenovirus 5
The document describes a streamlined adenovirus (AdV) production process that integrates optimized upstream methods with a scalable downstream purification strategy. Using suspension HEK cells and a single chromatographic step on...
End-To-End Process for Improved Purity, Combined With Innovative Analytics of LNP-Based Therapeutics
This poster presents a comprehensive approach to optimizing the mRNA-LNP production process, focusing on key steps from plasmid DNA expression in E. coli to encapsulating nucleic acids into lipid nanoparticles...
Monoliths for a Novel, Selective and High-Recovery Purification Process of LNP-Based Biopharmaceuticals
CIMmultus OH monolithic columns can be utilized as a chromatographic solution to purify LNPs. This process is used as a direct alternative to existing processes like TFF or dialysis, but...
Efficient rAAV8 Capsid Quantification in Upstream Process Development With Two-Dimensional Liquid Chromatography
Obtaining a high concentration and a significant proportion of full recombinant adeno-associated viruses (rAAV) capsids during production is important for the success of the entire AAV bioprocess. Analyzing complex upstream...
Immobilized Enzyme Reactors on Monoliths: A Platform For Efficient pDNA Linearization
Immobilized enzyme reactors (IMERs) on monolithic supports were developed for efficient plasmid DNA linearization, a critical step in mRNA production. EcoRI, NdeI, and HindIII were successfully immobilized, achieving comparable linearization...
Poster by Genethon | Full AAV9 Capsid Enrichment Step with the CIMmultus® PrimaT
Development of Full Capsid Enrichment Step in AAV Purification Process with CIMmultus® PrimaT Monolith CIMmultus PrimaT demonstrates efficient separation of empty and full AAV capsids even from AAV9 serotype....
Lentiviral Downstream Process Optimisation and Design of Experiments on CIM QA 0.05 mL Monolithic 96-Well Plates
Lentiviral vectors are being increasingly used as tools for stable integration of large gene inserts into the genomes of both dividing and non-dividing cells. With 3rd and 4th generation of...
Comparing Cation-Exchange Monolith and Affinity Resin for Chromatographic Capture and Purification of rAAV
This study evaluated the purification efficiency of the CIMmultus SO3 column compared to two commercially available affinity resins for Adeno-Associated Virus (AAV) purification. AAV material was prepared using two distinct...
Manufacturing Platform – From pDNA and mRNA to LNP With Multiple Nucleic Acids Loads
The typical mRNA production process is a complex sequence of four key steps, each crucial for ensuring the quality and efficacy of the final product. The process begins with the...
A Chromatographic Tool to Comprehensively Characterize Complex Novel RNA-LNP Drug Products
To address challenges in LNPs characterization, we have developed a method capable of simultaneously evaluating key parameters of the LNP formulations.
Common Properties of Extracellular Nanoparticles From Various Sources: Utilizing Chromatography for a Comprehensive Characterization of Complex Samples
Challenges in achieving high purity preparations and limitations in established analytics remain a rudimentary burden in studies of extracellular vesicles (EVs) and their biological roles. A good understanding of preparations’...
mRNA | saRNA Process Development With PATfix Analytical Platform
Recent advancements in mRNA-based vaccines and therapeutics have simplified production compared to traditional vaccines, enabling rapid large-scale output. The process involves in vitro transcription (IVT) and chromatographic purification, requiring effective...
Monolithic Columns for a High Recovery Purification Process of RNA-LNP Vaccines and Therapeutics
To address challenges in LNPs characterization, we have developed a method capable of simultaneously evaluating key parameters of the LNP formulations.
Advancing AAV Analytics: Post-DGUS Profiling as a Robust Tool for AAV Capsid Characterization
Density gradient ultracentrifugation (DGUC) is a well-established method for separating empty (E) and full (F) AAV capsids based on density differences. However, traditional DGUC is labour-intensive and lacks direct detection...
Monolithic Columns Enable Streamlined Downstream Processing and Analytics of Lipid Nanoparticles
Lipid nanoparticles are leading non viral carriers for therapeutics, offering versatility in encapsulating diverse payloads. Their manufacturing superiority over viral systems allows for modularity, speed, and scalability. However, this modularity...
2D-LC Evaluation of Complex Samples Containing Extracellular Vesicles
The aim of the study was the development of a robust and high-throughput method that would enable a comprehensive evaluation of extracellular vesicles (EVs) in complex samples. Our goal was...
Effective Endotoxin Reduction in Bacteriophage Samples Using CIMmultus Monolithic Technology
Endotoxins are robust and persistent impurity, which are native to majority of phage substrates. Two anion exchangers, CIMmultus PrimaS and H-Bond, were tested for their capacity for endotoxin removal in...
Grafting Chromatographic Monoliths With Charged Linear Polymers for Highly Productive and Selective Plasmid DNA Purification
Increased requirements for plasmid DNA (pDNA) in gene therapy and vaccination efforts brings the need for efficient large-scale production processes with high purity and productivity. Chromatographic purification of pDNA is...
High Reproducibility, Homogeneity, and Scalability of CIM® QA HR Chromatographic Monoliths Demonstrated by Separation of Empty and Full AAV Capsids
One of the key challenges in adeno-associated virus (AAV) viral vector manufacturing is effective and consistent separation of full AAV particles (containing the full recombinant DNA of the gene of...
Rapid Desalting of E. Coli Cell Lysate for CGE Analysis Using Monolithic Spin Columns
Neutralized E. coli cell lysate is a complex intermediate sample in the production process of plasmid DNA (pDNA) for use in vaccines and gene therapy. It contains various amounts of...
High-Speed Quantification of Immunoglobulin G – CIMac r-Protein A Analytical Column
CIMac™ r-Protein A Analytical Column is short bed, high performance monolithic column . Primarily is intended for fast, efficient, and reproducible qualitative and quantitative analyses of Immunoglobulin G (IgG). It...
Phosphopeptide Enrichment on a Monolithic Column Containing Superficially Immobilized Nano TiO2
Enrichment of phosphopeptides prior to LC-MS analysis is a crucial sample preparation step because of their low stoichiometry in biological sample, longer retention on reversed phase columns, and lower ionization...
PATfix® Analytical Method for Orf Virus Sample Characterization
In recent years, the Orf virus (ORFV) has become a promising tool for protective recombinant vaccines and oncolytic therapy. Regardless of the high potential for use and the broad range...
Reverse-Phase Chromatography Removes Double-Stranded RNA, Fragments and Residual Template to Decrease Immunogenicity and Increase Cell Potency of mRNA and saRNA
We present a comprehensive study of ion-pair reverse-phase (IP-RP) chromatography for mRNA polishing, demonstrating its ability to remove double-stranded RNA (dsRNA), RNA fragments and residual DNA template. We developed a...
Utilizing CIMmultus® OH for Efficient Purification of MSC EVs
Mesenchymal stem cell (MSC)-derived extracellular vesicles (EVs) have promising therapeutic potential in diverse applications, such as tissue regeneration and immunomodulation. On the pathway to the clinic, there is a substantial...
Optimization of mRNA Production and Purification | Characterization And Controlling of Post Transcriptional Polyadenylation
While mRNA therapeutics developed in recent years show tremendous potential, there are still technical obstacles to overcome, two of the most significant being mRNA’s intrinsic instability and its immunogenicity. In...
PATfix | At-Line Monitoring of Impurities and Critical Quality Attributes in Biopharmaceutical Up- And Downstream Processes Using PATfix Analytical Fingerprinting
Production of high value biological therapeutics usually involves complex manufacturing processes with high process variability. Additionally, development of robust and reliable bioprocesses can be challenging. PAT aims to enhance bioprocess...
Fast Purification and Analysis of Influenza A Virus Using CIMac Monolith Columns
New vaccines against Influenza A are required each year to keep up with the most virulent evolving strains. This highlights a need for predictive analytical tools that can aid purification...
Sample Displacement Chromatography of Plasmid DNA Isoforms
Preparative scale chromatographic separation of open-circular (oc) from supercoiled (sc) plasmid DNA (pDNA) isoforms has been already established on CIM C4 with high ligand density (C4 HLD) monolithic columns with...
An Industrial Purification Platform for AAV
This poster presents fully scalable non-affinity purification strategy that has been proven to be effective for all AAV serotype tested to date. Cell lysate is directly subjected to column purification...
Estimation of Empty and Full AAV10 Particle Ratio Using the Multi-Angle Light Scattering Detector
Serotype 10 adeno-associated virus (AAVrh_10mCherry) was analysed on the PATfix system with the CIMac AAV full/empty analytical column to estimate the ratio of empty and full AAV particles based on...
Comparison of Fluorescence and Multi-Angle Light Scattering for Rapid Quantitation of Bacteriophage
One of the handicaps of working with bacteriophages is the long duration required to perform plaque assays. Plaque assays also impose questions about accuracy and precision relative to the scale...
Two Step Purification Process for Bacteriophages With CIM Monoliths
Bacteriophages represent immense potential as therapeutic agents. Many of the most compelling applications of bacteriophages involve human therapy, some pertinent to gene therapy, others involving antibiotic replacement. In bacteriophage research...
Exosome Purification With CIMmultus EV-1 Advanced Composite Column
Exosomes fulfill a critical role as communicators among cells, with targeting and message content depending on their surface receptors and payload. This makes them obvious candidates for an extensive range...
Process Monitoring Using Immunofluorescence and Multi Angle Light Scattering | Tracking Extracellular Vesicles on Analytical PATfix Platform
This poster shows how Multi-Angle Light Scattering detector and Fluorescence detector coupled to PATfix analytical system can be used to track extracellular vesicles through purification process. Samples were analyzed by...
Orthogonal Characterization of AAV Samples by Simultaneous Monitoring of Multiple Analytical Parameters During Chromatography
Fast, accurate, and meaningful characterization of cell culture harvests and in process samples is critical for both process development and for documentation of in process control. UV analysis of chromatography...
Fluorescence, Light Scattering and UV Absorbance Detector Calibration Plots of Empty and Full AAV2|8 Capsid Mixtures
AAV vector lots are generally a heterogeneous mixture of empty particles (i e do not contain DNA) and full particles (i.e. contain DNA). Different spectrometric based methods can be used...
Improving Separation of Empty and Full AAV Capsids With a New Multimodal Column Chemistry: CIMac PrimaS (AAV) Beta
Separation of empty and full AAV capsids is important analytically as a means of monitoring the effects of different transfection strategies, cell culture conditions, lysis methods, sample preparation and purification...
Characterization of Empty and Full AAV Capsids in Complex Samples by Anion Exchange HPLC With Multiple Monitors
Bioreactor cell supernatants or post lysis materials entering downstream purification are heterogeneous mixtures of empty, full, and misassembled AAV capsids mixed with host cell proteins, genomic DNA, chromatin complexes, and...
Removal of Host Cell DNA and Other Contaminants From Exosome Preparations
Removal of host cell DNA is essential for all human-injectable biologics. This poster shows a method for achieving low host cell levels in preparations of exosomes. Purified exosome samples were...
Effect of Mg 2+ Ion Concentration on IVT Reaction Kinetics Determined by Novel Rapid Analytical HPLC Assay
The IVT reaction is one of the most expensive steps in mRNA production process and its optimization to reach high mRNA yield is of key importance. Standard mRNA quantification techniques...
Empty | Full Capsids Separation Using Three Different Modalities
Removal of impurities generated in the production of adeno associated virus (AAV) is an important step as they may pose a serious health risk, as well as deteriorate the economics...
Increasing Dynamic Binding Capacity of Oligo dT Using CIM 96 Well Oligo dT Plates
How to increase the binding capacity of Oligo dT18? Can a design of experiment approach be used to optimise Oligo dT binding? Is the monolith available in a high throughput...
Matrix Effects on UV Determination of mRNA Content
Microvolume spectrophotometers are commonly used as quick and easy method to measure concentration and purity of nucleic acids. DSP process for purification of mRNA includes unit operations with salt concentrations...
CIM SO3 Monolithic 96-Well Plate for Fast and Efficient rAAV Capture Step Screening After Kryptonase-Tff Pretreatment
Standard 96-well design offers a great advantage for screening many samples or conditions and supports process automatization. Our approach was multi-parallel screening of different mobile phases for rAAV capture step...
Improved Separation of AAV Capsids using AEX Chromatography
Strong anion exchange (AEX) chromatography is commonly used for separation of AAV capsids. The gold standard for target entities elution in ion exchange (IEX) chromatography is using an increasing salt...
Immobilized Enzymatic Reactors on Monolith Backbone for Rapid Plasmid Linearization
Immobilized enzyme reactors (IMERs) stand as innovative biotechnological constructs, seamlessly merging the catalytic proficiency of enzymes with the advantages of solid support matrices. Immobilized enzymes offer notable benefits such as...
Application of PATfix SEC and CIM Anion Exchange Chromatography for Optimization of EV Upstream Production
Extracellular vesicles (EVs) are a diverse group of particles secreted by all living cells. Numerous different therapeutic applications of both native and engineered EVs are currently in different stages of...