<p><strong>Quantifiable consistency. By tracking retention time consistency and peak symmetry across years of production, column performance becomes directly comparable.</strong></p><p>In chromatography, inconsistent separations are inconvenient and costly.</p><p>Every unexpected shift in retention time or change in peak shape can trigger a cascade of troubleshooting, reruns, and uncertainty that slows laboratory productivity.</p><p>On the other hand, when columns perform consistently, laboratories recover valuable time, reduce uncertainty, and maintain confidence in their data. True batch-to-batch consistency means fewer failed validations, fewer investigations, easier audits, and smoother collaboration across global sites.</p><p>In regulated industries, data integrity underpins every decision, from early development to final release testing, so consistent column performance is a necessity.</p><h3><strong>Key takeaways</strong></h3><ul><li>Batch-to-batch (U)HPLC column consistency directly influences long-term method performance by stabilizing retention times, preserving peak shape, and supporting reliable validation of pharmaceutical methods.</li><li>Multi-year performance data across thousands of columns shows us how controlled column manufacturing reduces chromatographic variability, supporting reproducible results across column formats, batches, and laboratories.</li><li>Stable (U)HPLC columns minimize revalidation, troubleshooting, and method transfer challenges in regulated workflows, improving analytical efficiency across the product lifecycle.</li></ul><h3><strong>Defining and measuring batch-to-batch (U)HPLC column consistency</strong></h3><p>A (U)HPLC column is packed with <a target="_blank" rel="noopener noreferrer" href="https://www.thermofisher.com/content/lifetech/global/en/home/industrial/chromatography/chromatography-learning-center/chromatography-consumables/consumable-types.html"><strong>solid-phase particles</strong></a><strong> </strong>that <a target="_blank" rel="noopener noreferrer" href="https://www.thermofisher.com/content/lifetech/global/en/home/industrial/chromatography/chromatography-learning-center/liquid-chromatography-information/hplc-system-components/how-hplc-columns-work.html"><strong>separate compounds by chemical structure</strong></a>.</p><p>If medium composition differs even slightly between manufacturing batches, retention times and peak shapes can change. These differences might seem minor, but in pharmaceutical analysis they can trigger failed validations, unnecessary troubleshooting, and inconsistent data across labs.</p><p>A recent evaluation of<a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/pdf/TG_20762_LC_Hypersil_GOLD_TG_20762_EN_ebcf64d4d6/TG-20762-LC-Hypersil-GOLD-TG20762-EN.pdf"><strong> Thermo Scientific Hypersil GOLD columns</strong></a> examined whether<a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/en-us/lcms/products?category=48&amp;manufacturerItems=3&amp;search=gold"><strong> these columns </strong></a>perform consistently across years of production. The answer: our results found sustained performance over time.</p><p>Across roughly <strong>17,500 columns tested over three years</strong>, researchers focused on two major indicators of a manufacturer’s column performance:</p><ul><li>Relative retention time (RRT), which is essentially how consistently compounds elute off the column.</li><li>Peak asymmetry, a reflection of column packing quality and how well peaks “behave.”</li></ul><p>In a recent technical note:<strong> </strong><a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/pdf/tn_004127_ccs_hypersil_gold_reversed_phrase_reproducibility_tn004127_na_en_d6375a67fb.pdf"><strong>Evaluation of batch-to-batch consistency of reversed-phase HPLC columns for long-term method validation</strong></a>, we evaluated three column configurations: a 250 mm × 4.6 mm, 5 μm column; a 150 mm × 4.6 mm, 5 μm column; and 50 mm × 2.1 mm, 5 μm column, using a test mixture of five compounds selected to represent different hydrophobicities.</p><p>Despite differences in column geometry and media batches, the method produced highly consistent chromatographic performance.</p><p>The method also achieved RRT relative standard deviation variation of no more than <strong>2.11% </strong>for the compounds and kept peak asymmetry within a narrow range of <strong>0.92 to 1.09</strong>. This level of control reduces uncertainty from long-term method validation, reinforcing confidence in predictable, reproducible column performance.</p><h3><strong>Why column stability over time matters</strong></h3><p>As an experienced analyst, you already know how frustrating <a target="_blank" rel="noopener noreferrer" href="https://www.thermofisher.com/content/lifetech/global/en/home/industrial/chromatography/chromatography-learning-center/liquid-chromatography-information/hplc-method-development-steps.html"><strong>method validation</strong></a><strong> </strong>can be. You think you’ve nailed the method, only to find the results from run to run. Often, the issue isn’t you. It’s the tools.</p><p>When your column behaves the same every time, you will see several downstream benefits, such as:</p><p><strong>1. Improved confidence in data interpretation</strong></p><p>You don’t have to keep wondering whether differences in your data are coming from your chemistry or your column.</p><p><strong>2. Methods stay valid longer</strong></p><p>Pharmaceutical companies must monitor drug purity throughout the product lifecycle, from development to manufacturing to quality control. A column that performs consistently over time makes comparisons straightforward and reliable.</p><p><strong>3. Method transfer is more reliable</strong></p><p>Large companies operate across multiple global sites. When everyone uses columns that behave consistently, transferring methods becomes seamless rather than a months-long headache.</p><p><strong>A closer look at column performance data</strong></p><p>The published technical note visualizes column performance using clean, simple charts (<strong>Figure 1</strong>).</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Thermo_Fisher_Scientific_What_Multi_Year_Batch_Data_Reveals_About_U_HPLC_Column_Consistency_18faa4e44c.jpg" alt="Thermo Fisher Scientific: What Multi-Year Batch Data Reveals About (U)HPLC Column Consistency: Figure 1.&nbsp; (Top image) Batch-wise average RRT, normalized by o-Xylene for Hypersil GOLDTM 250 mm x 4.6 mm 5 µm (83 batches). (Bottom image) Average peak asymmetry evaluation of o-xylene Hypersil GOLDTM 250 mm x 4.6 mm 5 µm (83 batches)." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Thermo_Fisher_Scientific_What_Multi_Year_Batch_Data_Reveals_About_U_HPLC_Column_Consistency_18faa4e44c.jpg 245w," sizes="100vw" width="1000" height="600"></p><p><strong>These graphs show us:</strong></p><ul><li>Tight clusters of RRT points across 83 batches, depending on column format.</li><li>Nearly identical behavior between columns of different dimensions, which is a sign of effective manufacturing process controls.</li><li>Peak asymmetry values hovering around 1.0, indicating well-packed columns producing sharp, reliable peaks.</li></ul><p>This data might not seem glamorous at first glance, but for anyone who’s spent hours troubleshooting peak tailing, drifting retention times, or inconsistent quality control (QC) results, these charts are beautiful.</p><h3><strong>Why column consistency matters for long-term method performance</strong></h3><p>In automated LC workflows, a small change in column behavior can affect multiple downstream outputs: integration, peak purity assessment, and calculated assay/impurity results. Over time, this can translate into system suitability failures, drift outside validated ranges, and additional validation or comparability work.</p><p>Column stability and batch-to-batch reproducibility are therefore critical for sustaining validated methods over time. The multi-batch data presented here demonstrate how controlled manufacturing processes can maintain consistent retention behavior and peak shape over time.</p><p>To learn how to test your column and determine what data to look for, read our technical note, <a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/pdf/tn_004127_ccs_hypersil_gold_reversed_phrase_reproducibility_tn004127_na_en_d6375a67fb.pdf"><strong>Evaluation of batch-to-batch consistency of reversed phase HPLC columns for long-term method validation</strong></a>.</p><h3><strong>FAQs</strong></h3><div><div><h5><strong>1. How does batch-to-batch consistency in LC columns affect chromatographic results?</strong></h5><p>Batch-to-batch consistency has a direct impact on the stability of chromatographic results. When columns are manufactured consistently, retention times remain stable and compounds elute at predictable intervals — run after run and batch after batch.<br><br>This stability reduces unexpected shifts in selectivity or peak shape, helping analysts distinguish true method-related changes from column-related variability.</p></div><div><h5><strong>2. How do you measure batch-to-batch consistency in LC columns?</strong></h5><p>Batch-to-batch consistency is evaluated by applying the same standardized test method to columns produced across multiple manufacturing lots and by comparing key chromatographic performance metrics.<br><br>Commonly monitored parameters include RRT, which reflects retention stability and peak asymmetry, which indicates packing quality and peak integrity. By tracking these metrics over many batches and extended production periods, manufacturers can quantify variability and ensure controlled, reproducible column performance.</p></div><div><h5><strong>3. How does batch-to-batch LC column consistency support long-term method validation and transfer between laboratories?</strong></h5><p>Consistent LC column performance plays an important role in sustaining validated methods over time, particularly in regulated pharmaceutical environments.<br><br>When column behavior remains stable across production batches, methods are more likely to stay within established acceptance criteria, reducing the need for revalidation or investigation. This stability is especially valuable throughout the product lifecycle, from development through quality control and release testing.<br><br>Batch-to-batch consistency also facilitates smoother method transfer between laboratories and global sites. When different labs use columns that perform the same way, chromatographic results are more predictable, making transfers faster, more efficient, and less prone to variability-related delays.</p></div></div><blockquote><p><strong>Visit us on&nbsp;</strong><a target="_blank" rel="noopener noreferrer" href="https://www.linkedin.com/showcase/72003132/admin/dashboard/"><strong><u>LinkedIn:</u></strong></a>&nbsp;#UHPLC #ColumnsAndConsumables #pharmaceutical</p></blockquote>

What Multi-Year Batch Data Reveals About (U)HPLC Column Consistency

<p><strong>Chromatogram-based library searching can provide a fast first identification, but it does not always give analysts the flexibility needed to evaluate alternative candidates, adjust precursor settings, or choose different spectral comparison strategies. In his presentation, James Little of Mass Spec Interpretation Services shows how </strong><a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/pdf/Chromatogram_Sent_to_Lib_Search_d324bc4118.pdf"><strong>transferring chromatogram results into the standard NIST Library Search window</strong></a><strong> can expand the available search options and provide a more detailed view of potential compound matches.</strong></p><p>The workflow is particularly relevant when an analyst wants to go beyond the single best chromatogram result and investigate alternative library candidates, compare spectra using different scoring approaches, or perform MS/MS searches with greater control over precursor information.</p><h3><strong>Why move from the chromatogram to Library Search?</strong></h3><p>The chromatogram view is useful for rapid inspection, but according to the presentation, its library-search functionality is more limited.</p><p>One of the main differences is that the chromatogram result list displays only the <strong>best library result</strong>, while the standard Library Search window provides access to <strong>alternative candidates</strong>. This can be important when several structures produce similar spectra or when the highest-ranked match needs additional scrutiny.</p><p>The standard Library Search window also provides more control over MS/MS searching. While searches initiated directly from the chromatogram use the precursor information automatically supplied by the chromatogram, the Library Search window allows the user to work with different search modes and modify precursor settings where required.</p><p>To transfer a component from the chromatogram into Library Search, the workflow shown in the presentation is straightforward: <strong>right-click the component of interest and select “Library Search.”</strong></p><h3><strong>Identity and similarity searches</strong></h3><p>Once the spectrum has been transferred, the search settings determine how the library comparison is performed.</p><p>With <strong>Identity</strong> selected, an MS/MS search can reproduce the type of search performed from the chromatogram. If the <strong>“In spectrum”</strong> option is enabled, the precursor sent from the chromatogram is used automatically. The option can also be disabled, allowing the analyst to enter a different precursor manually.</p><p>An additional option is <strong>HiRes No Precursor</strong>. In this mode, the spectra are compared without restricting the search according to the precursor ion. The presentation highlights this approach as useful for obtaining <strong>substructural information</strong>, since the comparison is not constrained to entries matching a specified precursor.</p><p>The <strong>Similarity</strong> mode provides access to <strong>Hybrid Search</strong>. Here again, the precursor imported from the chromatogram can be used automatically or replaced by another value. Hybrid Similarity itself is treated separately in the source presentation series, but its availability is one of the reasons for working in the full Library Search environment.</p><h3><strong>Choosing the right spectral matching method</strong></h3><p>The Library Search window also provides several ways to score spectral similarity:</p><ul><li><strong>Full Spectrum Search</strong></li><li><strong>Impurity Tolerant Search (Reverse-Dot)</strong></li><li><strong>Partial Spectrum Search (PSS-Dot)</strong></li></ul><p>Each is designed for a different analytical situation.</p><ul><li><strong>Full spectrum matching</strong> compares the complete experimental and library spectra and is most appropriate when the acquired spectrum is clean and complete.</li><li><strong>Reverse-Dot matching</strong> focuses primarily on whether important peaks from the library spectrum are present in the experimental spectrum. Extra peaks in the measured spectrum that are absent from the library spectrum are not penalized in the same way. This can make the approach more tolerant of chemical background or spectral contamination.</li><li><strong>Partial Spectrum Search</strong> addresses the opposite situation. It does not strongly penalize library peaks that are missing from the experimental spectrum and is therefore suited to incomplete spectra, including cases where only a subset of fragment ions is observed, such as some MS/MS or filtered datasets.</li></ul><p>Although the results table can display multiple similarity metrics, the search method selected before the search begins is important because of the way <strong>Presearch</strong> operates.</p><h3><strong>Why Presearch matters</strong></h3><p>NIST uses a Presearch step to reduce the number of library spectra that require more detailed comparison.</p><p>This significantly increases search speed, but it also means that spectra removed during Presearch will not appear later in the final results—even if another scoring metric might have ranked them favorably.</p><p>This is why the presentation emphasizes choosing the appropriate search method <strong>before Presearch</strong> when Reverse-Dot or Partial Spectrum behavior is important.</p><p>For example, running a standard Full Spectrum search and then sorting the final result table by Reverse-Dot does not necessarily reproduce the same candidate set that would have been obtained if an impurity-tolerant search had been selected from the beginning. Potentially relevant candidates may already have been excluded during the initial Presearch stage.</p><p>For routine reviewing, the presentation recommends using the overall <strong>NIST Score</strong> as the primary sorting criterion, while remembering that specialized searches may require a different search strategy from the outset.</p><h3><strong>Selecting libraries and mass tolerances</strong></h3><p>Before running the search, analysts can specify which libraries should be included.</p><p>The presentation illustrates the Library Search settings where individual spectral libraries can be added or removed from the search. This allows the search space to be tailored to the application rather than automatically searching every available library.</p><p>For high-resolution MS/MS data, users can also configure <strong>mass tolerances</strong> for both precursor and product ions.</p><p>These settings are particularly important because overly broad tolerances may increase the number of irrelevant candidates, while unnecessarily narrow tolerances could exclude valid matches. The appropriate values therefore need to reflect the quality and mass accuracy of the acquired data.</p><p>The software also provides additional options associated with precursor handling and polarity matching.</p><h3><strong>Understanding the result scores</strong></h3><p>Once the search is complete, the result table can be customized to support efficient review.</p><p>Properties can be added, reordered, resized, and used for sorting. The presentation notes that the results are normally best reviewed initially by <strong>Score</strong>.</p><p>Two related measures discussed are the <strong>dot product</strong> and the NIST <strong>Score</strong>.</p><p>The dot product reflects the direct similarity between two spectra based on shared peaks and their intensities. The NIST Score builds on this comparison by applying additional weighting and scaling. According to the presentation, this helps preserve useful matching performance when spectra are incomplete, as may occur with MS/MS or filtered spectral data.</p><p>Analysts can also sort by <strong>Rev-Dot</strong> or <strong>Partial Spectrum Search (PSS)</strong> values. However, the limitations imposed by the initial Presearch still apply: sorting cannot recover candidates that were already removed before the detailed comparison stage.</p><p>The result interface can also be navigated efficiently using the keyboard arrow keys, and the available display properties can be rearranged according to the analyst’s preferred review workflow.</p><h3><strong>Additional filters for faster review</strong></h3><p>The presentation also highlights two useful post-search filters:</p><ul><li><strong>Best Matching Only</strong></li><li><strong>MS/MS Hit Filter List options</strong></li></ul><p>Unlike Presearch, these filters are applied <strong>after</strong> the candidate search has already been completed. They can therefore be switched on and off without permanently removing candidates from the search process.</p><p>The <strong>Best Matching Only</strong> option removes many duplicate results and can make the candidate list easier to review.</p><p>The <strong>MS/MS Hit Filter</strong> provides additional filtering options for tandem MS results, including parameters related to instrument type and allowed precursor forms.</p><p>James Little notes that he generally keeps these filters disabled initially and applies them only when needed. This approach preserves the complete search result set during the first review and allows filtering to be introduced later as a tool for improving efficiency.</p><h3><strong>More flexibility for library-based identification</strong></h3><p>The main advantage of moving chromatogram results into the full NIST Library Search window is not that the original chromatogram search is incorrect, but that the dedicated search environment gives the analyst <strong>more control over how the spectrum is interrogated</strong>.</p><p>It allows alternative candidates to be reviewed, precursor restrictions to be modified, different identity and similarity strategies to be selected, and specialized full-spectrum, impurity-tolerant, or partial-spectrum comparisons to be performed.</p><p>Just as importantly, the workflow highlights a subtle but important principle in spectral searching: <strong>the scoring method used to review results and the method used to generate the candidate set are not necessarily interchangeable</strong>. Because Presearch determines which library spectra proceed to detailed evaluation, analysts should choose the search strategy that best reflects the characteristics of their experimental spectrum before beginning the search.</p><p>Used in this way, the NIST Library Search window can provide a more flexible and transparent workflow for investigating chromatographic components and evaluating MS/MS library matches.</p>

 Searching Normal NIST Search with Chromatogram Results

<p><strong>Is your lab ready for the new academic year? As students and teachers return to the laboratory, now is a great time to prepare your chromatography systems for the semester ahead.</strong></p><p>Now with <strong>20% total discount</strong> on a <strong>new </strong><a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/en-us/all/products/999"><strong>Clarity Chromatography Software</strong></a> for customers from educational institutions. In addition, customers purchasing a new license for Clarity Chromatography Software will receive a <strong>free copy of </strong><a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/en-us/all/products/1000"><strong>Clarity Offline Chromatography Software</strong></a>.</p><blockquote><p class="cke-user_style-important"><strong>👉Promotion code: MKT2114</strong></p><p>The offer is valid through the <strong>end of October 2026.</strong></p></blockquote><p><strong>The latest version of Clarity Chromatography Software - 10.2 was released in June 2026! </strong><a target="_blank" rel="noopener noreferrer" href="https://labrulez.com/en-us/all/article/7512"><strong>Read the article HERE.</strong></a></p>

Back to School: 20% Off Clarity Chromatography Software

Article

Product

Academy

Software

Video

Since 1991 DataApex develops and manufactures chromatography data stations. DataApex is constantly striving to provide users with efficient and up-to-date tools for chromatography data processing.

DataApex

A unique company dedicated to serving science helping our customers drive productivity and accelerate results. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services.

Thermo Fisher Scientific

My main interest is the identification of organic compounds by mass spectrometry in organic mixtures.

James Little/Mass Spec Interpretation Services

Waters Aura+ System for particle characterization

Fast, decisive particle characterization for biologics. Aura+ delivers high-throughput, 5 µL analysis with BMI and FMM imaging for proteins, antibodies, and cell/gene therapies.

<h4><strong>Fast, decisive, low-volume particle characterization analysis for biotherapeutic workflows</strong></h4><p><strong>When you need the flexibility to conduct particle characterization analyses on different types of biologics, including protein and antibody therapeutics, cell therapies, and gene therapies, the Aura+ System has you covered.</strong></p><p>Fully configured to support applications across protein, antibody, cell, and gene therapy workflows, Aura+ brings particle characterization to earlier stages of therapeutic development, so you can make better decisions sooner.</p><p>Powered by the backgrounded membrane imaging (BMI) and fluorescence membrane microscopy (FMM) technology shared within the Aura family of instruments, Aura+ System enables applications from late discovery to development and manufacturing, enhancing decision-making and accelerating your success.</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_Aura_System_18b9a5e9f5.jpg" alt="Waters: Aura+ System" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_Aura_System_18b9a5e9f5.jpg 234w," sizes="100vw" width="1024" height="682"></p><h4><strong>Specifications</strong></h4><ul><li><strong>Imaging area: </strong>24.6 mm2</li><li><strong>Optics: </strong>4x and 20x objectives</li><li><strong>Minimum volume:</strong> 5 µL (assay dependent)</li><li><strong>Resolution:</strong> 1.0 pixel/µm</li><li><strong>Detectable size range: </strong>Range from &gt;1 µm (ECD) to &lt;5 mm (ECD)</li><li><strong>BMI read time: </strong>1 minute/sample</li><li><strong>FMM read time:</strong> 3 FL channels, 30 seconds/sample</li><li><strong>Software:</strong> Particle VUE 4.x all-in-one software suite (image capture and analysis)</li></ul><h4><strong>Overview</strong></h4><ul><li>Save precious material with just 5 µL sample volume requirements&nbsp;</li><li>Get actionable results from a full 96 well plate of labeled samples to data in just 90 minutes</li><li>Boost efficiency with 96-well membrane plate high-throughput capability</li><li>Gain deeper particle insights with advanced imaging</li><li>Rely only on one platform for proteins, antibodies, and cell and gene therapies development</li></ul><p><strong>Recommended Use: </strong>For workflows requiring complete flexibility across a full spectrum of analytes, including biologics, viral vectors, cells, and other contaminants.​</p><h4><strong>Take the guesswork out of your aggregate ID</strong></h4><p>Don’t waste time troubleshooting incorrectly identified aggregates in your therapeutic. Aura+ System uses a combination of brightfield and fluorescent imaging to specifically ID and quantitate cell, viral capsid, protein, degraded excipients, and packaging contaminants so you’ll know exactly what’s in your sample.​</p><p>With high-throughput 96-well plate capability, 5 µL sample volumes, and results in as little as 90 minutes, it offers an efficient solution for detailed particle analysis, meeting USP &lt;788&gt; and &lt;1788&gt; requirements.</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_Aura_Identify_cell_doublets_and_triplets_1_cellular_aggregates_2_protein_aggregates_3_and_plastic_contaminants_4_in_a_cell_therapeutic_sample_5227e05a6d.jpg" alt="Waters: Aura+ System - Identify cell doublets and triplets (1), cellular aggregates (2), protein aggregates (3), and plastic contaminants (4) in a cell therapeutic sample." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_Aura_Identify_cell_doublets_and_triplets_1_cellular_aggregates_2_protein_aggregates_3_and_plastic_contaminants_4_in_a_cell_therapeutic_sample_5227e05a6d.jpg 234w," sizes="100vw" width="1024" height="682"></p><h4><strong>BMI: The key to sensitive, robust, early-stage particle characterization</strong></h4><p>Backgrounded membrane imaging (BMI) provides a clearer, faster, and more comprehensive view of what’s really in your sample. By capturing and subtracting background images of the membrane, BMI achieves 10x greater contrast than liquid-based measurements such as light obscuration and flow imaging. Aura+ System provides aggregate data without any clogging concerns or the need for cleaning between measurements.</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_Aura_BMI_achieves_10x_greater_contrast_than_liquid_based_measurements_such_as_light_obscuration_and_flow_imaging_06d3a7349c.jpg" alt="Waters: Aura+ System - BMI achieves 10x greater contrast than liquid-based measurements such as light obscuration and flow imaging." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_Aura_BMI_achieves_10x_greater_contrast_than_liquid_based_measurements_such_as_light_obscuration_and_flow_imaging_06d3a7349c.jpg 234w," sizes="100vw" width="1024" height="682"></p><h4><strong>Get fast, definitive particle identification with three fluorescence channels</strong></h4><p>The Aura+ System comes with three fluorescence channels so you can get the same information from one experiment that would otherwise take three different studies.</p><p>In addition, The Aura+ System definitively identifies different types of particles within the same sample for more reliable decision-making:</p><ul><li>Three fluorescence membrane microscopy (FMM) channels for three different species of organic particles</li><li>Side illumination membrane imaging (SIMI) channel for extrinsic and inorganic particles</li><li>Ideal for applications including polysorbate degradation, particulate contamination, protein &amp; antibody workflows, cell therapy workflows, AAV aggregation, AAV stability, cell therapy QC, and cell viability</li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_Aura_Cells_protein_aggregate_and_ig_G_via_immunoassay_6c3e43ecc4.jpg" alt="Waters: Aura+ System - Cells, protein aggregate, and igG (via immunoassay)." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_Aura_Cells_protein_aggregate_and_ig_G_via_immunoassay_6c3e43ecc4.jpg 234w," sizes="100vw" width="1024" height="682"></p><h4><strong>Obtain clear details with high magnification</strong></h4><p>With the high magnification capabilities of the Aura+ System, you can see more morphological detail of unlabeled particles, enabling decisive discrimination between your lead and undesirable particles.</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_Aura_Quickly_differentiate_and_enumerate_cells_versus_Dynabeads_quantify_polysorbate_degradation_and_more_b3e24050f2.jpg" alt="Waters: Aura+ System - Quickly differentiate and enumerate cells versus Dynabeads™, quantify polysorbate degradation, and more." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_Aura_Quickly_differentiate_and_enumerate_cells_versus_Dynabeads_quantify_polysorbate_degradation_and_more_b3e24050f2.jpg 234w," sizes="100vw" width="1024" height="682"></p>

Waters Aura PTx System for particle characterization

Aura PTx combines BMI and fluorescence microscopy to rapidly detect protein aggregates and polysorbate degradation from just 5 µL of sample.

<p><strong>The Aura PTx System is an innovative analytical platform designed to accelerate protein formulation development and stability screening for therapeutic drug development. Combining Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) with dual fluorescence channels, the system enables rapid detection, counting, and characterization of protein aggregates and excipient degradation products within a single experiment.</strong></p><p>Unlike traditional imaging methods that rely solely on particle morphology, Aura PTx can distinguish protein and non-protein particles using fluorescence-based identification. The combination of <strong>Thioflavin T (ThT)</strong> and <strong>BODIPY FL C16</strong> staining enables simultaneous assessment of protein aggregation and polysorbate degradation, two critical indicators of biologic formulation stability.</p><p>Requiring only 5 µL of sample and supporting automated 96-well plate workflows, the Aura PTx System is ideally suited for high-throughput formulation screening during early-stage development of therapeutic proteins, monoclonal antibodies, and other biologics.</p><h3><strong>Key Features</strong></h3><ul><li>Combines BMI and FMM technologies in one platform</li><li>Dual fluorescence channels for simultaneous analysis</li><li>Distinguishes protein and non-protein particles</li><li>Detects and quantifies protein aggregates</li><li>Monitors polysorbate degradation</li><li>Simultaneous protein and excipient stability assessment</li><li>Requires only 5 µL sample volume</li><li>Automated 96-well plate workflow</li><li>High-throughput formulation screening</li><li>No cleaning required between measurements</li><li>Fast sample processing and analysis</li><li>Suitable for Design of Experiments (DoE)</li><li>Supports biologics development</li><li>Early detection of formulation stability issues</li></ul><h3><strong>Technical Specifications</strong></h3><h4><strong>Technology</strong></h4><ul><li>Backgrounded Membrane Imaging (BMI)</li><li>Fluorescence Membrane Microscopy (FMM)</li><li>Dual-channel fluorescence detection</li></ul><h4><strong>Optics</strong></h4><ul><li>Objective: 4×</li><li>Resolution: 1.0 pixel/µm</li><li>Imaging area: 24.6 mm²</li></ul><h4><strong>Particle Detection</strong></h4><ul><li>Detectable size range:<ul><li>1 µm (ECD)</li><li>&lt;5 mm (ECD)</li></ul></li></ul><h4><strong>Sample Handling</strong></h4><ul><li>Minimum sample volume: 5 µL</li><li>Compatible with 96-well plates</li><li>Optimized for high-throughput screening</li></ul><h4><strong>Analysis Speed</strong></h4><ul><li>BMI read time: 1 minute per sample</li><li>FMM read time: 30 seconds per sample</li></ul><h4><strong>Fluorescence Analysis</strong></h4><ul><li>Thioflavin T (ThT) for protein aggregate detection</li><li>BODIPY FL C16 for polysorbate degradation analysis</li><li>Simultaneous protein and excipient characterization</li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_The_Aura_P_Tx_System_tells_you_exactly_what_is_protein_via_Th_T_staining_and_what_is_not_even_in_mixed_particles_9cb34b80b1.jpg" alt="Waters: The Aura PTx System tells you exactly what is protein (via ThT staining) and what is not, even in mixed particles." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_The_Aura_P_Tx_System_tells_you_exactly_what_is_protein_via_Th_T_staining_and_what_is_not_even_in_mixed_particles_9cb34b80b1.jpg 234w," sizes="100vw" width="1024" height="682"></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_The_Aura_P_Tx_System_is_the_first_to_use_thioflavin_T_Th_T_and_BODIPY_FL_C16_staining_to_detect_and_quantify_protein_aggregates_and_polysorbate_breakdown_fc113affba.jpg" alt="Waters: The Aura PTx System is the first to use thioflavin T (ThT) and BODIPY FL C16 staining to detect and quantify protein aggregates and polysorbate breakdown." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_The_Aura_P_Tx_System_is_the_first_to_use_thioflavin_T_Th_T_and_BODIPY_FL_C16_staining_to_detect_and_quantify_protein_aggregates_and_polysorbate_breakdown_fc113affba.jpg 234w," sizes="100vw" width="1024" height="682"></p><h4><strong>Software</strong></h4><ul><li>Particle Vue™ 4.x Software Suite</li><li>Integrated data analysis</li><li>Automated particle identification and characterization</li></ul><h4><strong>Typical Applications</strong></h4><ul><li>Biopharmaceutical development</li><li>Protein formulation screening</li><li>Monoclonal antibodies</li><li>Biosimilars</li><li>Stability studies</li><li>Excipient screening</li><li>Polysorbate degradation monitoring</li><li>Aggregate characterization</li><li>Design of Experiments (DoE)</li><li>Biologics quality control</li></ul>

Waters Aura GT System for particle characterization

Aura GT enables characterization of AAV and viral vectors from just 5 µL of sample, including detection of capsid and DNA aggregates using BMI and FMM technologies.

<p><strong>The Aura GT System is the first dedicated platform designed for the detection, counting, and characterization of viral vectors used in gene therapy, including AAV (Adeno-Associated Virus) and lentiviral vectors. Combining Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) with dual fluorescence channels, the system enables rapid and reliable assessment of viral particle aggregation and stability during early-stage development.</strong></p><p>Requiring only <strong>5 µL of sample</strong>, Aura GT allows characterization even when only limited material is available. Using fluorescent dyes such as <strong>Thioflavin T (ThT)</strong> and <strong>SYBR™ Gold</strong>, researchers can distinguish capsid aggregates from DNA-containing aggregates, identify root causes of instability, and gain valuable insights into viral vector quality.</p><p>The system supports high-throughput 96-well plate screening and enables direct comparison of formulations, AAV serotypes, production lots, storage conditions, and stability profiles. Results that traditionally required months of work can now be obtained within hours.</p><h3><strong>Key Features</strong></h3><ul><li>Combines <strong>BMI and FMM technologies</strong> in one platform</li><li>Specifically designed for <strong>AAV, lentivirus, and viral vectors</strong></li><li>Detects, counts, and characterizes viral aggregates</li><li>Differentiates <strong>capsid and DNA aggregates</strong></li><li>Identifies root causes of aggregation and instability</li><li>Requires only <strong>5 µL sample volume</strong></li><li>Dual fluorescence channels for simultaneous characterization</li><li>High-throughput <strong>96-well plate screening</strong></li><li>Direct comparison of formulations, serotypes, and production lots</li><li>Viral vector stability assessment</li><li>Actionable results within hours</li><li>Eliminates labor-intensive traditional assays</li><li>Optimized for gene therapy development</li><li>High sensitivity and throughput</li></ul><h3><strong>Technical Specifications</strong></h3><h4><strong>Technology</strong></h4><ul><li>Backgrounded Membrane Imaging (BMI)</li><li>Fluorescence Membrane Microscopy (FMM)</li><li>Dual-channel fluorescence detection</li></ul><h4><strong>Optics</strong></h4><ul><li><strong>Objective:</strong> 4×</li><li><strong>Resolution: </strong>1.0 pixel/µm</li><li><strong>Imaging area: </strong>24.6 mm²</li></ul><h4><strong>Particle Detection</strong></h4><ul><li>Detectable size range:<ul><li>1 µm (ECD)</li><li>&lt;5 mm (ECD)</li></ul></li></ul><h4><strong>Sample Handling</strong></h4><ul><li><strong>Minimum sample volume: </strong>5 µL</li><li><strong>Compatible with 96-well plates</strong></li><li>Optimized for high-throughput screening</li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_Get_your_gene_therapy_products_to_market_even_faster_with_Aura_GT_System_195d42d00b.jpg" alt="Waters: Get your gene therapy products to market even faster with Aura GT System." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_Get_your_gene_therapy_products_to_market_even_faster_with_Aura_GT_System_195d42d00b.jpg 245w," sizes="100vw" width="1024" height="522"></p><h4><strong>Analysis Speed</strong></h4><ul><li><strong>BMI read time:</strong> 1 minute per sample</li><li><strong>FMM read time: </strong>30 seconds per sample</li><li>2 fluorescence channels</li></ul><h4><strong>Fluorescence Analysis</strong></h4><ul><li>Thioflavin T (ThT) for capsid aggregate detection</li><li>SYBR™ Gold for DNA detection</li><li>Simultaneous identification of protein and DNA aggregates</li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_Identify_root_cause_and_characterize_AAV_particles_at_low_volume_with_Aura_GT_System_c3f1c6a334.jpg" alt="Waters: Identify root cause and characterize AAV particles at low volume with Aura GT System." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_Identify_root_cause_and_characterize_AAV_particles_at_low_volume_with_Aura_GT_System_c3f1c6a334.jpg 234w," sizes="100vw" width="1024" height="683"></p><h4><strong>Software</strong></h4><ul><li>Particle Vue™ 4.x Software Suite</li><li>Image acquisition and analysis</li><li>Automated particle characterization</li></ul><h4><strong>Typical Applications</strong></h4><ul><li>Gene therapy development</li><li>AAV vector characterization</li><li>Lentiviral vectors</li><li>Stability studies</li><li>Aggregation studies</li><li>AAV serotype comparison</li><li>Formulation screening</li><li>Production lot evaluation</li><li>DNA aggregate analysis</li><li>Viral vector development</li></ul>

Waters Aura CL System for particle characterization

Waters Aura CL rapidly identifies cells, aggregates, and residual Dynabeads™ from just 5 µL of sample while assessing viability and purity in cell therapy workflows.

<p><strong>The Aura CL System is the first dedicated platform designed for rapid identification, counting, and characterization of subvisible particles in cell therapy development and manufacturing. Unlike traditional methods, it can reliably distinguish viable cells, unwanted particles, protein aggregates, and manufacturing-related contaminants such as Dynabeads™, while simultaneously providing cell counts, viability information, and sample purity assessment.</strong></p><p>The system combines <strong>Backgrounded Membrane Imaging (BMI)</strong>, <strong>Fluorescence Membrane Microscopy (FMM)</strong>, and <strong>Side Illumination Membrane Imaging (SIMI)</strong> technologies to deliver fast, automated particle analysis without subjective operator interpretation. Through fluorescence labeling, users can clearly differentiate cellular from non-cellular particles, protein from non-protein aggregates, and various cell populations within complex samples.</p><p>Requiring only <strong>5 µL of sample</strong>, Aura CL supports high-throughput screening and can analyze up to 96 samples in less than one hour, making it an ideal solution for cell therapy development, manufacturing, and quality control workflows.</p><h3><strong>Key Features</strong></h3><ul><li>Combines <strong>BMI, FMM, and SIMI </strong>technologies</li><li>Automated identification of <strong>cells and non-cell particles</strong></li><li>Detection and counting of residual<strong> Dynabeads™</strong></li><li>Cell viability assessment</li><li>Characterization of subvisible particles</li><li>Differentiates <strong>protein and non-protein aggregates</strong></li><li>Distinguishes<strong> cellular and non-cellular particles</strong></li><li>Requires only<strong> 5 µL sample volume</strong></li><li>High-throughput <strong>96-well plate screening</strong></li><li>Fully automated analysis workflow</li><li>Results within minutes</li><li>Supports cell therapy development and manufacturing</li><li>Greater accuracy than manual hemocytometry</li><li>Reduces human interpretation errors</li></ul><h3><strong>Technical Specifications</strong></h3><h4><strong>Technology</strong></h4><ul><li>Backgrounded Membrane Imaging (BMI)</li><li>Fluorescence Membrane Microscopy (FMM)</li><li>Side Illumination Membrane Imaging (SIMI)</li></ul><h4><strong>Optics</strong></h4><ul><li><strong>Objectives:</strong><ul><li>4×</li><li>10×</li></ul></li><li><strong>Resolution: </strong>1.0 pixel/µm</li><li><strong>Imaging area:</strong> 24.6 mm²</li></ul><h4><strong>Particle Detection</strong></h4><ul><li>Detectable size range:<ul><li>1 µm (ECD)</li><li>&lt;5 mm (ECD)</li></ul></li></ul><h4><strong>Sample Handling</strong></h4><ul><li><strong>Minimum sample volume: </strong>5 µL</li><li>Compatible with 96-well plates</li><li>Optimized for high-throughput screening</li></ul><h4><strong>Analysis Speed</strong></h4><ul><li><strong>BMI read time: </strong>1 minute per sample</li><li><strong>FMM read time: </strong>30 seconds per sample</li></ul><h4><strong>Fluorescence Analysis</strong></h4><ul><li>Cell and non-cell particle identification</li><li>Cell viability measurements</li><li>Protein aggregate detection</li><li>Non-protein particle detection</li><li>Fluorescent antibody and cell labeling applications</li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Waters_With_Aura_CL_System_you_can_achieve_high_throughput_and_definitive_identification_of_viable_cells_and_take_the_guesswork_out_of_cell_viability_assessments_a46a5ee8b4.jpg" alt="Waters: With Aura CL System, you can achieve high-throughput and definitive identification of viable cells and take the guesswork out of cell viability assessments." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Waters_With_Aura_CL_System_you_can_achieve_high_throughput_and_definitive_identification_of_viable_cells_and_take_the_guesswork_out_of_cell_viability_assessments_a46a5ee8b4.jpg 234w," sizes="100vw" width="1024" height="682"></p><h4><strong>Software</strong></h4><ul><li>Particle Vue™ 4.x Software Suite</li><li>Image acquisition and analysis</li><li>Automated particle classification</li><li>Viability and purity assessment tools</li></ul><h4><strong>Typical Applications</strong></h4><ul><li>Cell therapy development</li><li>CAR-T manufacturing</li><li>Cell product quality control</li><li>Residual Dynabeads™ detection</li><li>Cell viability testing</li><li>Cell culture purity monitoring</li><li>Subvisible particle characterization</li><li>Biologics development</li><li>Lot release testing</li><li>Manufacturing process control</li></ul>

Products from category Particle Size Analyzers from Waters - page 1

Related content

Back to School: 20% Off Clarity Chromatography Software

What Multi-Year Batch Data Reveals About (U)HPLC Column Consistency

Searching Normal NIST Search with Chromatogram Results