<p>The pioneering research of Prof. Michal Holčapek and his team at the University of Pardubice is now being tested on patients in a clinical setting.</p><p><strong>A clinical trial has begun in the Czech Republic to assess the effectiveness of an early detection test for pancreatic cancer. This trial will evaluate the sensitivity of a novel blood test designed to detect precancerous changes. If successful, this lipidomics-based test could revolutionise pancreatic cancer screening, offering a major advance in early diagnosis.</strong></p><p>The trial is a collaborative effort between Lipidica – a company jointly owned by the University of Pardubice and FONS JK Group – and specialists in gastroenterology and oncology. Lipidica will perform sample analyses for the clinical study. Key partners include the University Hospital Olomouc and the Masaryk Memorial Cancer Institute, with a total of 15 centres nationwide expected to participate.</p><blockquote><h4><strong>Career: Postdoctoral Positions in Lipidomics and Glycomics</strong></h4><ul><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/job/1713">more details and contacts</a></li></ul><p><strong>You will be joining the dynamic Lipidomics Group at the University of Pardubice, working on high-impact research funded by prestigious grants:</strong></p><ol><li><strong>ERC Advanced grant “Oncolipidomics:</strong> Why is lipidomic dysregulation pattern in blood similar for various cancers? (ONCOLIPID)”</li><li><strong>OP JAK grant “Saving lives through research in early cancer detection and prevention:</strong> Molecular, genomic and societal factors (SALVAGE)”</li></ol><h5><strong>Two Postdoctoral Positions in Lipidomics and Glycomics</strong></h5><ul><li><strong>Start Date:</strong> January 2025 (or as soon as possible)</li><li><strong>Duration:</strong> 12 months, with a possibility of extension until the end of the project (August 2028)</li><li><strong>Location:</strong> Lipidomics Group of Prof. Michal Holčapek, University of Pardubice, Faculty of Chemical Technology, Department of Analytical Chemistry, Czech Republic</li><li><strong>Salary:</strong> Competitive, based on university guidelines, and commensurate with experience and skills.</li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/University_of_Pardubice_University_of_Pardubice_254470ec4e.jpg" alt="University of Pardubice: University of Pardubice" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_University_of_Pardubice_University_of_Pardubice_254470ec4e.jpg 234w," sizes="100vw" width="1200" height="803"></p></blockquote><p>This methodology, which allows for early diagnosis, was developed by Prof. Michal Holčapek, a prominent analytical chemist and world-renowned expert in lipids at the University of Pardubice’s Faculty of Chemical Technology. Holčapek, a recipient of the prestigious European ERC Advanced grant, and his team achieved this breakthrough by analysing lipids in standard blood samples and applying advanced multivariate statistical analysis. <i><strong>"The lipidomics test is non-invasive and could pave the way for a structured screening programme,”</strong></i> explains Prof. Holčapek. <i><strong>"It may enable earlier detection of pancreatic cancer, where treatment success rates are higher and patient survival outcomes improve."</strong></i></p><p>This innovative method has been published in Nature Communications, one of the world’s leading scientific journals, and is protected by two patents held by the University of Pardubice.</p><p>Experts from the Czech Gastroenterological Society (CGS) report that approximately 2 400 people are diagnosed with pancreatic cancer each year in the Czech Republic, and nearly 2 200 die from the disease within the same period. By 2030, experts project that pancreatic cancer will become the second leading cause of cancer deaths. <i>"Pancreatic cancer is among the most aggressive forms of cancer – it develops asymptomatically over more than a decade but remains undetected until it is too advanced for effective treatment,"</i> says Prof. Ondřej Urban, M.D., Ph.D., Head of the Second Internal Gastroenterology and Geriatric Clinic at University Hospital Olomouc. <i>"By the time symptoms appear, it is often too late for curative treatment, with surgery remaining the only potential cure, but only about 20% of patients qualify. The rest receive palliative care focused on extending life with as much quality as possible."</i> For those with advanced pancreatic cancer, the average survival rate is about 1.5 years. However, patients diagnosed at an early stage can live up to six times longer. <i>"We know that lipid profiles vary significantly in patients with pancreatic cancer,"</i> Prof. Urban adds.<i> "This study aims to determine if the lipidomics test can detect these early lipid changes in high-risk individuals who feel healthy but may already have underlying disease."</i></p><p>According to doc. MUDr. Jan Trna, Ph.D., Chief Physician of the Gastroenterology Department at the Masaryk Memorial Cancer Institute, the successful validation of the new lipidomics test would represent a major breakthrough in pancreatic cancer treatment.<i> "Currently, our options for identifying individuals at risk for pancreatic cancer are limited. Due to financial, capacity, and medical constraints, specialised preventive testing cannot be offered to everyone. However, blood sampling presents a different approach. For decades, we have sought methods to detect the disease early – which is absolutely critical for this particular cancer," </i>says MUDr. Trna. The Pancreatic Cancer Early Detection Programme now enables the identification of precancerous changes or early-stage cancer. Under this programme, gastroenterologists collaborate closely with clinical geneticists and radiologists who conduct specialised tests such as magnetic resonance imaging (MRI).</p><p>Currently, the screening programme is available only to individuals with a lifetime risk of pancreatic cancer exceeding 5%. <i>"In the newly established centres of highly specialised care for digestive endoscopy, including our department, at-risk individuals undergo regular pancreatic examinations using MRI and endoscopic ultrasonography,"</i> explains doc. MUDr. Ilja Tachecí, Ph.D., Chair of the CGS and Head of the Second Internal Gastroenterology Clinic at the Faculty of Medicine, Charles University in Hradec Králové. Individuals considered at risk include those with a hereditary form of chronic pancreatitis, those with two or more direct relatives diagnosed with pancreatic cancer, and carriers of specific genetic mutations – such as mutations in the BRCA1 and BRCA2 genes, which are also associated with breast and ovarian cancer.</p><p><i>"People at risk visit us for annual check-ups. As part of this study, we collect blood samples with their informed consent, which are then processed into plasma and sent to the Lipidica laboratory,"</i> explains Prof. Urban. The study thus analyses blood from both healthy high-risk individuals and patients with small, operable tumours. <i>"Current diagnostic methods are highly effective but also costly and uncomfortable for patients. A test based on a simple blood draw would be a tremendous benefit for clinical practice. Our LDPC lipidomics test relies on a patent-protected methodology developed at the University of Pardubice, integrating insights from analytical chemistry, biostatistics, and other scientific disciplines,"</i> adds Ing. Karolína Kašparová, Director of Lipidica, which is also an accredited medical laboratory.</p><p><strong>Lipidica, a.s., a joint venture between the University of Pardubice and FONS JK Group a.s., has been </strong><a target="_blank" rel="noopener noreferrer" href="https://www.upce.cz/en/neuron-awards-goes-to-lipidica-spin-off-of-the-university-of-pardubice"><strong>recognised with the Neuron Prize</strong></a><strong> for its exceptional bridging of science and business.</strong></p><p><strong>The study began this year and is expected to conclude in 2027, involving over 400 participants. </strong>If the test's specificity and sensitivity are confirmed, experts note it may still take time before the test becomes a standard part of clinical care and before it is determined whether health insurers will cover it or if individuals will need to pay out of pocket. The manufacturer has indicated, however, that the price should not exceed a few thousand Czech korunas.&nbsp;</p>

Clinical trial begins in Czech Republic to test groundbreaking pancreatic cancer detection method

<blockquote><p><i>Maciej Stopa<sup>1, 2</sup>; Rafał Szewczyk<sup>1, 2</sup>; Adrianna Radulska<sup>3</sup>, Anna Lenartowicz<sup>2</sup>; Julia Mironenka<sup>2</sup>; Adrian Soboń<sup>1, 2</sup>; Katarzyna Krupczyńska-Stopa<sup>1, 2</sup>; Tomasz Borkowski<sup>3</sup>; Ewelina Marciniak<sup>3</sup>, Leszek Kalinowski<sup>3</sup></i></p><p><i><sup>1</sup></i><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/companies/315"><i><strong>Bioanalytic</strong></i></a><i><strong> </strong>Sp. z o.o., Gdansk, Poland; <sup>2</sup>LabExperts Sp. z o.o., Gdansk, Poland; <sup>3</sup> Medical University of Gdansk, Gdansk, Poland</i></p></blockquote><h4><strong>Abstract</strong></h4><p>Cardiac arrhythmia affects approximately 12.6% of people over the age of 65. Ventricular arrhythmias are considered as responsible for 75% to 80% of sudden cardiac deaths. Therapy of the disease include ablation, use of cardioverter or defibrillator and pharmacological treatment where the key for successful therapy lays in maintaining the necessary concentration of drugs. The goal can be achieved by therapeutic drug monitoring (TDM). Developed assay named “CardioCarePack” is based on the use of capillary blood collected and dried at home by a patient with volumetric absorptive microsampling (VAMS), quantitative analysis of selected drugs and their metabolites and a telemedical system that integrates all data between a doctor, patient and laboratory supporting the therapy process. CardioCarePack is ready for commercialization.</p><h4><strong>Methods</strong></h4><p>Blood collected with a <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products?distributorItems=315&amp;search=MITRA"><strong>MITRA® microsampling device</strong></a> (20 µl) is prepared with full validated protocol that include sonication with 0.1% formic acid in water followed by acetonitrile extraction, evaporation under nitrogen stream and resuspension in LC mobile phase. Sample is subjected to LC-MS/MS analysis in positive ionization MRM mode with QTRAP 5500+ mass spectrometer (SCIEX) or similar one. Analysis covers simultaneous quantitation of 15 drugs: Sotalol, Metoprolol, Bisoprolol, Propafenone, Carvedilol, Nebivolol, Amiodarone, Digoxin, Perindopril, Ramipril, Eplerenone, Spironolactone, Zofenopril and 2 metabolites: 5-hydroxypropafenone and Desethylamiodarone. Results are placed in a server-based telemedical system where depending on accession rights history, doses, therapeutic index flagging, cardiograms, sample tracking and many other data are available for patient, doctor and laboratory staff, respectively.</p><h4><strong>Preliminary Data</strong></h4><p>The project involved more than 300 patients who had been monitored for 2 years during regular pharmacological therapy. Every half a year during a visit in medical facility venous blood for serum testing and capillary blood on the MITRA® sorbent were collected. Between the visits patients were collecting samples by VAMS themselves at home. All samples were analyzed by fully validated procedure where among the others linearity (r ≥ 0.995), accuracy (80 – 120%), reproducibility (%CV ≤ 15%) for both MITRA® and serum samples were calculated. The LC-MS/MS method developed for 17 compounds covers therapeutic range of the tested drugs: 0.25 – 25 ng/ml (Digoxin and Nebivolol) 2.5 – 250 ng/ml (Metoprolol, Bisoprolol, Propafenone, Carvedilol, Perindopril, Ramipril, Spironolactone, Zofenopril and 25 – 2500 ng/ml (Sotalol, Desethylamiodarone, Eplerenone, Amiodarone, 5-hydroxypropafenone). Results generated during LC-MS/MS analysis were analyzed with SCIEX OS 1.7 software.</p><p>On the basis of samples collected during 4 visits in medical facility a correlation between drugs concentration in venous blood (serum) and capillary blood (MITRA®) (S/M) was calculated. For some compounds S/M ratio was close to 1 (ex. Sotalol – 0.95, %CV – 5.12%, Nebivolol – 1.03, %CV – 3.17%) or moderately to more than 2-fold different (ex. Digoxin – 0.69, %CV – 1.46%, Ramipril – 1.18, %CV – 11.1, Perindopril – 1.86, %CV – 4.73%, Amiodarone – 2.17, %CV – 10.78). The correlation factors are statistically significant (p &lt; 0.05) and can be used for accurate concentration estimation in venous blood.</p><p>Developed telemedicine system integrate CardioCarePack service – a patient, doctor and LC-MS/MS laboratory. The system helps in Doctor’s supervision over the patient’s condition on the basis of collected within the system data ex.: autonomous verification of the therapeutic index with flagging, visualization of results, tracking samples on the patient-doctor line, schedule of visits, results history and many more.</p><h4><strong>Novel aspect</strong></h4><p>A modern telemedicine system for TDM of cardiological drugs based on LC-MS/MS analysis of samples collected at home with VAMS.</p>

CardioCarePack – personalized medicine system to improve live quality of patients suffering from cardiac arrhythmias

<p><strong>In the week of January 13, the following webinars await you in the field of liquid phase and especially HPLC and LC/MS.</strong></p><blockquote><p><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinars"><strong>👉 DETAILS AND REGISTRATION IN THE WEBINARS SECTION</strong></a></p><p><strong>👉 Search and filter in the largest global database</strong> with over <strong>3 500 GC, LC, MS and spectroscopy webinars</strong>.</p></blockquote><h5><strong>1. Waters Corporation: Light scattering-based solutions for excipients and advanced formulations</strong></h5><div><div><ul><li><div>Tu, 14.1.2025 05:00 CET</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4545">Registration</a></div></li></ul></div><p>In this webinar, we will showcase case studies demonstrating how SEC-MALS and FFF-MALS are utilized to characterize, quantify, and deformulate advanced excipients and formulations.</p></div><h5><strong>2.&nbsp;Thermo Fisher Scientific: Well characterized biological products, challenging yet rewarding</strong></h5><div><div><ul><li><div>Tu, 14.1.2025 11:00 CET</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4578">Registration</a></div></li></ul></div><p>The presentation emphasizes the importance of developing innovative methods and technologies to support the ecosystem and enhance data workflows. It introduces the concept of a new facility, named "Concept".</p></div><h5><strong>3.&nbsp;Agilent Technologies: Getting the Most from Your Agilent HPLC Pump</strong></h5><div><div><ul><li><div>Tu, 14.1.2025 17:00 CET</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4519">Registration</a></div></li></ul></div><p>We will focus on your Agilent HPLC pump. We will look at some of its capabilities and how to choose the right column for it. We will discuss best practices to help maximize up-time.</p></div><h5><strong>4.&nbsp;Restek Corporation: Incorporating ultrashort-chain compounds into the comprehensive analysis of PFAS</strong></h5><div><div><ul><li><div>We, 15.1.2025 17:00 CET</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4569">Registration</a></div></li></ul></div><p>Join Dr. Shun-Hsin Liang, as he explores the simultaneous analysis of C1 to C14 PFCA and PFSA, along with other PFAS types, using two alternative chromatographic approaches.</p></div><h5><strong>5.&nbsp;SCIEX: Unlocking precision: nitrosamine and NDSRI analysis</strong></h5><div><div><ul><li><div>Th, 16.1.2025 10:30 CET</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4682">Registration</a></div></li></ul></div><p>We invite you to join our webinar on nitrosamine and NDSRIs, specifically examining their analysis and implications in the pharmaceutical industry.</p></div><h5><strong>6.&nbsp;Thermo Fisher Scientific: The merger of automated LC fractionation &amp; in-depth characterization</strong></h5><div><div><ul><li><div>Th, 16.1.2025 11:00 CET</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4579">Registration</a></div></li></ul></div><p>Dr. Kristensen discusses how the shift from traditional data handling methods to cloud solutions has revolutionized their workflow, enabling access to vast amounts of data from anywhere.</p></div><h5><strong>7.&nbsp;Waters Corporation: Mastering the Quantitative Bioanalysis of Large Peptides and Proteins: A Case Study of GLP-1 Receptor Agonist Semaglutide in Plasma</strong></h5><div><div><ul><li><div>Th, 16.1.2025 15:00 CEST</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4384">Registration</a></div></li></ul></div><p>We present new data demonstrating a comprehensive and streamlined approach to optimized LC-MS/MS quantification of peptides, addressing the common challenges.</p></div><h5><strong>8.&nbsp;Waters Corporation:</strong> <strong>Method Validation</strong></h5><div><div><ul><li><div>Th, 16.1.2025 19:00 CET</div></li><li><div><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4669">Registration</a></div></li></ul></div><p>We´ll discuss practical guidance around accuracy, precision, limit of quantitation and limit of detection and next we´ll walk you through an Empower CDS tool.</p></div>

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Bioanalytic started its operations in 1998. The company was born from a passion for science and the need to provide innovative solutions in the laboratory equipment market, from a small business to a dynamically developing company with an established position.

Bioanalytic

Quantitative analysis of proteins (Bioanalytic) 

In our laboratory, proteomic analyses, including quantitative analysis of proteins, are performed by HPLC-MS or HPLC-MS/MS methods on a ZenoTOF 7600 high-resolution mass spectrometer (SCIEX).

<p><strong>Quantitative analysis of proteins is important in many industries and applications. Proteins include a diverse group of compounds that participate in virtually every biological process. Proteins are building blocks, hormones, transport molecules, cell receptors, cell growth and differentiation factors. Because of this, the analysis of protein interactions is crucial in drug design and production.</strong></p><p>Proteins are macromolecules - the basis of their structure are polypeptide chains containing from 100 to more than 10000 amino acids (10 - 100 kDa). Proteins are found in simple and complex forms. Complex proteins contain a non-protein component (sugar, lipids, metal ions or dyes) in their structure.</p><p>In our laboratory, proteomic analyses, including quantitative analysis of proteins, are performed by HPLC-MS or HPLC-MS/MS methods on a <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?manufacturerItems=52&amp;search=ZenoTOF+7600"><strong>ZenoTOF 7600</strong></a> high-resolution mass spectrometer (SCIEX). We process the obtained results using Sciex OS, Spectronaut, Skyline software.</p><h4><strong>MS vs MS/MS</strong></h4><p>Quantitative analysis of intact protein (whole protein in intact form) leads to the concentration (determined from a prepared curve from a standard (with or without matrix) and confirmation of the identification by superimposing (on a mirrored basis) the MS spectrum of the protein determined in the sample to the MS spectrum of the standard. For your needs, we can generate a list of protein-structured compounds (impurities) that were identified in the sample and determine the ratio of their signal area to the signal area of the analyzed protein.</p><p>The result of proteomic quantitative peptide analysis allows precise and much more sensitive determination of protein concentration. The analysis is based on MS/MS data obtained for peptides obtained by digestion with proteolytic enzymes. The reported result consists of the concentration of the protein under study and confirmation of its presence based on the determined amino acid sequence. For such analyses, it is recommended to add standards internal standards.</p><blockquote><p><span style="font-size:22px;"><strong>Our offer:</strong></span></p><ul><li>For proteins and peptides with low masses - intact analysis with MS detection;</li><li>Proteins with masses &gt;20kDa require optimization of the digestion method and MS/MS detection. This results in specific signals from the analyzed protein in the mixture/matrix;</li><li>From complex matrices (including serum, cell culture, fungal suspension), sample analysis involves several steps:&nbsp;<ul><li>Sample purification;</li><li>Digestion to obtain unique peptides to distinguish the analyzed proteins from other proteins in the sample;</li><li>Sample preparation requires appropriate method optimization and validation (let's set validation criteria individually);</li></ul></li><li>Reported quantitative result includes confirmation of the presence of the protein in native form or a peptide derived from it (usually confirmation includes at least two peptide sequences);</li><li>Statistical analysis using tools: MarkerView (PCA), GraphPad Prism, Trends, Sciex OS.</li></ul><p><i>To optimize and validate the method, it is necessary to provide a standard, in the case of proteins with high masses - it is recommended to add an internal standard.</i></p><p>See also:</p><ul><li><a target="_blank" rel="noopener noreferrer" href="https://labexperts.com.pl/service/identyfikacja-bialek/"><strong>Protein identification</strong></a><strong>,</strong></li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/1296"><strong>Analysis and characterization of monoclonal antibodies</strong></a><strong>.</strong></li></ul></blockquote><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Bioanalytic_Quantitative_analysis_of_proteins_1_de494646f2.jpg" alt="Bioanalytic: Quantitative analysis of proteins." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Bioanalytic_Quantitative_analysis_of_proteins_1_de494646f2.jpg 200w," sizes="100vw" width="777" height="606"></p>

Identification of the substance – what is in your sample? (Bioanalytic)

We are able to identify metabolites and products of chemical reactions, contaminants of biological and chemical substances and preparations, and perform profiling of a series of samples to study the kinetics of transformations.

<h4><strong>Substance Identification - Looking for answers to what's in your sample? - we can help you.</strong></h4><p>Substance identification based on LC-MS/MS techniques can involve single compounds or mixtures of substances. In our analyses, we rely primarily on the knowledge and skills we have acquired after many years of work. For analysis, we use full laboratory facilities for sample preparation and high-resolution mass spectrometry (<a target="_blank" rel="noopener noreferrer" href="https://labexperts.com.pl/o-nas/">equipment</a>).</p><p>We use different work algorithms depending on the material we are dealing with and the analytical task to be solved. We use DDA (IDA) or DIA (SWATH) methods or targeted approaches (e.g. MRMhr) if we know what to expect. Thus, we are able to identify metabolites and products of chemical reactions, contaminants of biological and chemical substances and preparations, and perform profiling of a series of samples to study the kinetics of transformations.</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Bioanalytic_Identification_of_the_substance_what_is_in_your_sample_2_0f425a648b.jpg" alt="Bioanalytic: Identification of the substance – what is in your sample" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Bioanalytic_Identification_of_the_substance_what_is_in_your_sample_2_0f425a648b.jpg 245w," sizes="100vw" width="1881" height="1156"></p><h4><strong>COST OF SERVICE</strong></h4><p>We determine the cost of the service individually. The final cost is influenced by many factors related to the nature of the sample itself and the client's expectations. Thus, the price depends, among other things, on the complexity of the sample preparation procedure, the scope and number of analyses, etc.</p><p><strong>The service includes (depending on individual arrangements):</strong></p><h5><strong>Development of sample preparation procedure</strong></h5><ul><li>Depending on the matrix and test substances.</li></ul><h5><strong>Development of analytical methods</strong></h5><ul><li>Application of high-resolution LC-MS/MS analyses using DDA (IDA) or DIA (SWATH) experiments and software to support the development of targeted screening methods.</li></ul><h5><strong>Analysis of results includes:</strong></h5><ul><li>finding and identifying the substances of interest, interpreting MS/MS spectra and proposing a structural formula.</li><li>Comparative analysis of sample series, e.g. PCA,</li><li>profiling of analytes in sample series</li></ul><h5><strong>Reporting of results</strong></h5><ul><li>Compile results into easy-to-read reports.</li></ul><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Bioanalytic_Identification_of_the_substance_what_is_in_your_sample_3_c1b8adc1d0.jpg" alt="Bioanalytic: Identification of the substance – what is in your sample" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Bioanalytic_Identification_of_the_substance_what_is_in_your_sample_3_c1b8adc1d0.jpg 245w," sizes="100vw" width="1919" height="1208"></p>

Characteristics of monoclonal antibodies (Bioanalytic)

At LabExperts, proteomic analyses are performed on a ZenoTOF 7600 high-resolution LC-MS/MS system (SCIEX). For MS/MS analyses, we use Collision induced dissociation (CID) and Electron-Activated Dissociation (EAD) fragmentation.

<p><strong>Antibodies are molecules made up of 4 polypeptide chains: two heavy (H - high-chain) linked to each other by a specific type of chemical bond - a disulfide bridge, and two light (L - light-chain) linked by an identical bond to the heavy chains. Monoclonal antibodies (mABs) are used in various forms - as free molecules, in the form of a drug-antibody combination, and in the form of an immunoconjugate, a drug-antibody-biopolymer combination.</strong></p><p>Their main use is in highly specific targeted therapy for cancer, cardiovascular, autoimmune and nervous system diseases. They are also used in the treatment of osteoporosis, Alzheimer's disease or transplantation. The range of applications of monoclonal antibodies is systematically expanded. The introduction of a new antibody to the market requires complex product characterization, which involves numerous proteomic analyses, which are performed by LC-MS/MS techniques, among others.</p><h4><strong>LC-MS/MS</strong></h4><p>The characterization of monoclonal antibodies involves many aspects, including, but not limited to, a suite of analyses related to confirmation of the structure, chain sequence and degree of modification of the antibody. Post-translational modifications (PTMs) are chemical changes that occur after the translation process. These changes generally result in an increase in the immunogenicity of the drug. For this reason, it is essential to monitor modifications as critical quality attributes (CQAs) during both the production and storage of the drug. To ensure monitoring of CQA points, the primary structure of the protein is characterized based on peptide mapping (peptide mapping) analysis. The protein under study is subjected to proteolytic digestion using enzymes such as trypsin, chymotrypsin, Lys-C, Glu-C. As a result of various proteolytic enzymes, a wide range of peptides is obtained. Ultimately, coverage of the entire sequence of the protein under study is obtained.</p><figure class="image"><img style="aspect-ratio:1536/947;" src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Bioanalytic_Characteristics_of_monoclonal_antibodies_3_d94fa1623b.jpg" alt="Bioanalytic: Characteristics of monoclonal antibodies." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Bioanalytic_Characteristics_of_monoclonal_antibodies_3_d94fa1623b.jpg 245w," sizes="100vw" width="1536" height="947"></figure><p>At LabExperts, proteomic analyses are performed on a <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?manufacturerItems=52&amp;search=ZenoTOF+7600"><strong>ZenoTOF 7600</strong></a> high-resolution LC-MS/MS system (SCIEX). For MS/MS analyses, we use Collision induced dissociation (CID) and Electron-Activated Dissociation (EAD) fragmentation. This provides us with data for unambiguous identification of protein-building amino acids. We process the results using Sciex OS, Skyline and Spectronaut software.</p><blockquote><p><span style="font-size:22px;"><strong>We perform:</strong></span></p><ul><li>Whole protein analyses - Intact - to determine the exact mass and confirm the theoretical mass;</li><li>N-glycosylation profile determination (based on MS spectrum reconstruction):<ul><li>Glycosylated form;</li><li>Deglycosylated;</li><li>Glycosylated with reduced disulfide bridges;</li><li>Deglycosylated with reduced disulfide bridges.</li></ul></li><li>Peptide maps:<ul><li>Protein digestion with various proteases so that sequence coverage is close to 100%<ul><li>Analysis of PTMs:</li><li>Location of modifications</li></ul></li><li>[%] of modifications compared to the unmodified sequence</li></ul></li><li>TiPOS testing - (technical proof of similarity) - technical confirmation of the similarity of the protein synthesized by the customer (from several LOTs) with the target protein (provided as a template).</li></ul><p>In order to maintain the highest possible analytical standards, we perform monoclonal antibody analyses under the regime of an internally developed and implemented laboratory quality system based on GLP principles.</p><p>See also our other proteomics services: <a target="_blank" rel="noopener noreferrer" href="https://labexperts.com.pl/service/identyfikacja-bialek/"><strong>Protein identification</strong></a>, <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/1294"><strong>Protein quantitative analysis</strong></a></p></blockquote><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Bioanalytic_Characteristics_of_monoclonal_antibodies_2_cb93143fe6.jpg" alt="Bioanalytic: Bioanalytic Characteristics of monoclonal antibodies." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Bioanalytic_Characteristics_of_monoclonal_antibodies_2_cb93143fe6.jpg 245w," sizes="100vw" width="1536" height="908"></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Bioanalytic_Characteristics_of_monoclonal_antibodies_1_0e8ab7cdfa.jpg" alt="Bioanalytic: Bioanalytic Characteristics of monoclonal antibodies." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Bioanalytic_Characteristics_of_monoclonal_antibodies_1_0e8ab7cdfa.jpg 245w," sizes="100vw" width="1536" height="858"></p>

Analysis of Anabolic steroids (Bioanalytic)

We offer a highly specific and sensitive qualitative analysis of a wide profile of anabolics by LC-HR-MS/MS technique (detection limits range from 0.01 to 5 ng/ml, depending on the substance).

<h4><strong>Anabolic substances in urine</strong></h4><p>The effect of anabolic steroids (<a target="_blank" rel="noopener noreferrer" href="https://en.wikipedia.org/wiki/Anabolic_steroid"><strong>more information</strong></a>) is to stimulate the growth of muscle mass and sometimes also bone mass by stimulating protein synthesis or altering calcium metabolism. This effect is often used in sports doping. However, anabolic steroids also have many side effects, as they strongly affect the body's overall hormonal balance.</p><p>Anabolic steroids used by purely recreational athletes are still not banned in most countries, including Poland. Nevertheless, their amateur use during adolescence often results in the inability to continue a professional sports career into adulthood or leads to hormonal imbalances in the body.</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Analysis_of_Anabolic_steroids_Bioanalytic_1_46fa2f41ca.jpg" alt="Bioanalytic: Analysis of Anabolic steroids." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Analysis_of_Anabolic_steroids_Bioanalytic_1_46fa2f41ca.jpg 245w," sizes="100vw" width="1200" height="740"></p><p>If you want to know whether and which anabolic substances are present in the samples of athletes, or you want to exclude doping in this area - use the offer carried out by us together with the company <a target="_blank" rel="noopener noreferrer" href="http://www.lab4tox.pl/"><strong>Lab4Tox</strong></a>. We offer a highly specific and sensitive qualitative analysis of a wide profile of anabolics by LC-HR-MS/MS technique (detection limits range from 0.01 to 5 ng/ml, depending on the substance). The use of high-resolution mass spectrometry (HR-MS and HR-MS/MS) in the analysis of anabolic steroids makes it possible to unequivocally confirm or exclude the presence of a given compound. The list of compounds at present includes:</p><ul><li><span class="ts-list-li-content">Boldenone undecylenate</span></li><li><span class="ts-list-li-content">Turinabol</span></li><li><span class="ts-list-li-content">Drostanolone enanthate</span></li><li><span class="ts-list-li-content">Drostanolone propionate</span></li><li><span class="ts-list-li-content">Methandienone</span></li><li><span class="ts-list-li-content">Methenolone acetate</span></li><li><span class="ts-list-li-content">Methenolone enanthate</span></li><li><span class="ts-list-li-content">Nandrolone phenylpropionate</span></li><li><span class="ts-list-li-content">Oxandrolone</span></li><li><span class="ts-list-li-content">Oxymetholone</span></li><li><span class="ts-list-li-content">Stanozolol</span></li><li><span class="ts-list-li-content">5-alpha-DHT</span></li><li><span class="ts-list-li-content">6-beta-hydroxymethandienone</span></li><li><span class="ts-list-li-content">19-norandrosterone</span></li><li><span class="ts-list-li-content">3'-hydroxystanazolol</span></li><li><span class="ts-list-li-content">4-beta-hydrozystanazolol</span></li><li><span class="ts-list-li-content">17-alpha-trenbolone</span></li><li><span class="ts-list-li-content">Testosterone caproate</span></li><li><span class="ts-list-li-content">Testosterone cypionate</span></li><li><span class="ts-list-li-content">Testosterone decanoate</span></li><li><span class="ts-list-li-content">Testosterone enanthate</span></li><li><span class="ts-list-li-content">Testosterone isocaproate</span></li><li><span class="ts-list-li-content">Testosterone phenylpropionate</span></li><li><span class="ts-list-li-content">Testosterone propionate</span></li><li><span class="ts-list-li-content">Testosterone undecanoate</span></li><li><span class="ts-list-li-content">Trenbolone acetate</span></li><li><span class="ts-list-li-content">Testosterone</span></li><li><span class="ts-list-li-content">Epitestosterone</span></li></ul><p><span class="ts-list-li-content">The list of compounds is not complete and will be systematically expanded according to customer needs.</span></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Analysis_of_Anabolic_steroids_Bioanalytic_2_78729119b0.jpg" alt="Bioanalytic: Analysis of Anabolic steroids is carried out by us together with the company Lab4Tox." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Analysis_of_Anabolic_steroids_Bioanalytic_2_78729119b0.jpg 245w," sizes="100vw" width="625" height="100"></p><p><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products?category=54&amp;distributorItems=315"><span class="ts-list-li-content"><strong>Other analytical methods we offer</strong></span></a><span class="ts-list-li-content">.</span></p>

Analysis of Synthetic Peptide Hormones (Bioanalytic)

We offer highly specific and sensitive quantitative analysis of peptides by LC-MS/MS technique (LOQ < 1 ng/ml).

<h4><strong>Synthetic peptide hormones - a study of the purity of formulations and composition of dietary supplements.</strong></h4><p>In sports doping, small synthetic peptide hormones represent an increasingly attractive class of supplements for improving physical performance in amateur and professional athletes. Their use, depending on the type of peptide, is aimed primarily at building muscle tissue while intensifying fat reduction processes combined with the induction of the body's regenerative processes.</p><p>Do you want to be sure that the peptide you are using is in the product in the amount declared by the manufacturer? Or do you have doubts that the supplement you are using is contaminated with these compounds? If you are troubled by these or similar questions - feel free to contact us. We perform tests in cooperation with <a target="_blank" rel="noopener noreferrer" href="http://www.lab4tox.pl"><strong>Lab4Tox</strong></a>. We offer highly specific and sensitive quantitative analysis of peptides by LC-MS/MS technique (LOQ &lt; 1 ng/ml). At the moment, we analyze the following peptides:</p><ul><li><span class="ts-list-li-content">GHRP-2</span></li><li><span class="ts-list-li-content">GHRP-6</span></li><li><span class="ts-list-li-content">BPC-157</span></li><li><span class="ts-list-li-content">Melanotan-2</span></li></ul><p><span class="ts-list-li-content">The list of compounds is not complete and will be systematically expanded according to customer needs.</span></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Analysis_of_Anabolic_steroids_Bioanalytic_2_78729119b0.jpg" alt="Bioanalytic: Analysis of Synthetic Peptide Hormones. We perform tests in cooperation withLab4Tox." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Analysis_of_Anabolic_steroids_Bioanalytic_2_78729119b0.jpg 245w," sizes="100vw" width="625" height="100"></p><p><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products?category=54&amp;distributorItems=315"><span class="ts-list-li-content"><strong>Other analytical methods we offer</strong></span></a><span class="ts-list-li-content">.</span></p>

Determination of nitrosamine content (Bioanalytic)

Our offer includes comprehensive development and validation of methods for determination of nitrosamines in pharmaceutical products. We perform the work according to the criteria and needs of the client based on the EMA note.

<p><strong>Determination of nitrosamines is one of the pharmaceutical industry's top priorities. After the presence of N-nitrosodimethylamine (NDMA) was first reported in an active pharmaceutical ingredient (API), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandated the identification and control of all APIs and finished products in which there is a risk of nitrosamines.</strong></p><p>The content of nitrosamines in drug products can be controlled primarily by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) analysis. More than that, a reliable analysis result in our offer consists of a well-chosen sample preparation procedure, a selective and sensitive analytical method, and the experience of the analyst, who selects the best method parameters at the optimization stage.</p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Determination_of_nitrosamine_content_Bioanalytic_2_ce4f440837.jpg" alt="Bioanalytic: Determination of nitrosamine content." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Determination_of_nitrosamine_content_Bioanalytic_2_ce4f440837.jpg 234w," sizes="100vw" width="1536" height="1024"></p><p><strong>We have gained experience working with leading pharmaceutical companies.</strong> As part of our ongoing work, we have developed analytical methods for small-molecule nitrosamines of 70-150 g/mol. These compounds are mainly formed during manufacturing processes and depend on the presence and type of excipients (e.g. NDBA - N-nitroso-dibutylamine). We have also developed methods for determining molecules with higher nitrosamine drug substance related impurities (NDSRIs). In our work, we focus on achieving the highest possible sensitivity, selectivity and precision. To this end, we individually select the parameters of the methods depending on the composition of the drug and the expected nitrosamines. Due to the above criteria and the required detection limits, we perform nitrosamine impurity determinations using LC-MS/MS kits based on <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?manufacturerItems=52&amp;search=QTRAP+5500%2B"><strong>QTRAP 5500+</strong></a> and <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?manufacturerItems=52&amp;search=QTRAP+6500%2B"><strong>QTRAP 6500+</strong></a> mass spectrometers (<a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?mainauthorItems=55"><strong>SCIEX</strong></a>).</p><blockquote><p><span style="font-size:22px;"><strong>Our offer</strong></span></p><p><strong>Our offer includes comprehensive development and validation of methods for determination of nitrosamines in pharmaceutical products.</strong> <strong>We perform the work according to the criteria and needs of the client based on the EMA note.</strong></p><p>At the stage of sample preparation, we focus on:</p><ul><li>obtaining the <strong>highest possible recovery</strong> of nitrosamines (matrix purification);</li><li><strong>limiting additional synthesis</strong> of impurities (selection of appropriate equipment and reagents);</li><li><strong>ensuring the stability</strong> of the sample prepared for LC-MS/MS analysis.</li></ul><p>During the optimization of the LC-MS/MS method, we solve such problems as:</p><ul><li>selection of an <strong>appropriate internal standard</strong>;</li><li><strong>separation of the impurity from the API</strong>;</li><li>obtaining the expected <strong>sensitivity of the analytical method</strong>.</li></ul><p><strong>Quantitative analysis of nitrosamines requires sensitivity, precision and accuracy, which we provide to our customers.</strong></p></blockquote><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Determination_of_nitrosamine_content_Bioanalytic_1_d629e00e62.jpg" alt="Bioanalytic: Determination of nitrosamine content." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Determination_of_nitrosamine_content_Bioanalytic_1_d629e00e62.jpg 103w," sizes="100vw" width="1130" height="1710"></p>

Identification of the proteins (Bioanalytic)

We perform proteomic analyses on a state-of-the-art high-resolution ZenoTOF 7600 (SCIEX), in which the Zeno ion trap and EAD (Electron-Activated Dissociation) technology together make a powerful combination.

<p><strong>Protein identification is based on experimental measurement of peptide molecular weights and matching the amino acid sequence of the protein under study with protein sequences deposited in libraries (databases). Two approaches are most commonly used in proteomic studies: top-down and bottom-up. The top-down method involves analyzing full protein sequences. Bottom-up analyses, on the other hand, use digestion of proteins with proteolytic enzymes. The peptides obtained by digestion are analyzed using a mass spectrometer. Each analysis leads to a comparison of experimental data with data obtained by theoretical digestion of proteins described in the database.</strong></p><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Identification_of_the_proteins_Bioanalytic_2_6231b73f0d.jpg" alt="Bioanalytic: Identification of the proteins." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Identification_of_the_proteins_Bioanalytic_2_6231b73f0d.jpg 245w," sizes="100vw" width="1536" height="766"></p><h4><strong>LC-MS/MS</strong></h4><p>Tandem mass spectrometers are commonly used to determine protein sequences. They allow ion selection of pseudomolecular peptides and then fragmentation and measurement of the masses of the resulting fragments. Fragmentation using <i>collision induced dissociation</i>(CID ) is an invaluable tool in targeted and untargeted MS/MS analysis of small molecules. It is important to note that in proteomic analysis, data obtained using the aforementioned fragmentation method may leave gaps. For example, spectra obtained by CID fragmentation do not allow unambiguous differentiation of some amino acids: leucine from isoleucine (identical molar masses and CID fragmentation) and lysine from glutamine (very similar masses). For this reason, we perform proteomic analyses on a state-of-the-art high-resolution <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?manufacturerItems=52&amp;search=+ZenoTOF+7600"><strong>ZenoTOF 7600</strong></a> (SCIEX), in which the Zeno ion trap and EAD (<i>Electron-Activated Dissociation</i>) technology together make a powerful combination. It enables the creation of unique fragments to differentiate problematic amino acids and increase the sensitivity and specificity of the analysis.</p><blockquote><p><span style="font-size:22px;"><strong>We perform analyses of:</strong></span></p><ul><li>samples from solution;</li><li>samples from a gel;</li><li>samples from a complex matrix (by prior arrangement);</li><li>samples from lyophilizer;</li><li>samples previously prepared by the client.</li></ul><p>Qualitative analysis of proteins includes:</p><ul><li>To confirm the presence of a protein, the sample is subjected to digestion and the result obtained from experimental data is compared with theoretical data;</li><li>Comparison of experimental data on the masses of peptides included in the analyzed protein with the protein sequences described in the database;</li><li>Analysis and identification of the protein mixture;</li><li>Identification of post translational modifications (PTMs) (we use the tools: Skyline, Spectronaut).</li><li>Reporting of the result including, but not limited to, confirmation of the coverage of the protein sequence obtained in the test sample with the theoretical protein and the list of modified peptides, location and % of modifications.</li></ul><p><span style="font-size:22px;"><strong>Comparative analyses include:</strong></span></p><ul><li>Determining the composition of mixtures;</li><li>Comparison and profiling of sample series - protein identification and trend analysis.</li></ul><p><span style="font-size:22px;"><strong>Our offer also includes</strong>:</span></p><ul><li>Support in the planning and execution of studies (the scope is determined individually);</li><li>Assistance in the development of extraction methods from complex matrices - biological fluids, plant tissue, animal tissues (the scope is determined individually);</li><li>Statistical analysis using tools: MarkerView (PCA), GraphPad Prism, Trends, Sciex OS;</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/1294"><strong>Quantitative analysis of proteins</strong></a>;</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/1296"><strong>Analysis and characterization of monoclonal antibodies</strong></a>.</li></ul></blockquote><p><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Identification_of_the_proteins_Bioanalytic_1_97cf8c94b3.jpg" alt="Bioanalytic: Identification of the proteins." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Identification_of_the_proteins_Bioanalytic_1_97cf8c94b3.jpg 117w," sizes="100vw" width="1500" height="2000"></p>

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