Genedata’s Post

Source: Journal of pharmaceutical and biomedical analysis This study optimized an HPLC-MS/MS method for determining atropine (ATR) and its metabolite (TRP) in biological samples. The study found that the choice of blood-collection tube and the analytical matrix can affect the accuracy of ATR detection. A chromatographic shift was observed in ATR peak in biological samples, potentially leading to false-negative results. The study recommends using heparin tubes for blood-sample collection and highlights TRP as an alternative toxicological marker for ATR toxicity.

Recently, we announced our big news: Tentamus Pharma UK acquired MALDI-TOF technology. Since then, we have received lots of inquiries about Pharmaceutical Microbial Identification testing and how our service using MALDI-TOF technology can help you comply with the updates to Annex 1 in 2023. Here are some frequently asked questions (FAQs) along with their responses: 🟢 What is MALDI-TOF technology? MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight) is a powerful analytical technique used for the rapid and accurate identification of microorganisms. It uses an ultraviolet laser to irradiate samples embedded in a matrix, inducing the acceleration of proteins and peptides. This acceleration enables them to travel towards the detector at a speed dependent on their mass. Subsequently, this speed is translated into an exact molecular mass, which is then compared with an internal database of microorganisms. 🟢 What are the benefits of using MALDI-TOF for microbial identification? Our in-house MALDI-TOF equipment allows us to provide our clients with several advantages, including rapid results and fast turnaround times, high accuracy and broad applicability across different types of microorganisms. 🟢 Can the MALDI-TOF service help us comply with the new updates to Annex 1 in 2023? Yes. With this service, there are flexible options for results to be delivered within a span of a few days, with high accuracy on a wide range of microorganisms. This particularly meets the latest update to EudraLex Annex 1, stating that enumeration is no longer enough; organisms need to be identified. Please feel free to message us at HelloUK@tentamus.com to learn more about it! #MicrobialIdentification #MALDITOF #Pharmaceutical #Testing #Annex1 #Tentamus

UNKNOWN BACTERIAL IDENTIFICATION - for personnel who require an overview of the laboratory techniques commonly used to determine the morphological and cultural characteristics of unknown bacteria. Follow SKILLPAD - digital learning for life sciences on LinkedIn at https://lnkd.in/eZt4kHw for more news and updates. Description and screenshots here: https://lnkd.in/eHnZe6ca Schedule your DEMO here: info@skillpad.com #pharmaceuticals #biopharmaceuticals #biotechnology #laboratory #analyticallaboratory #glp #gmp #bioprocessing #biologics #apimanufacturing #bacteria #asepticprocessing

Want to find out how to achieve a more uniform drug antibody ratio (DAR) profile and stable attachment for your #ADC? Attend our live webinar this Wednesday, March 27th, to learn how from our #bioconjugation experts Petra Dieterich, DPhil, MBA, and Nicolas Camper. They will share insights into design and development strategies for bioconjugates & ADCs and delve into the impactful role of linker technologies in accelerating and de-risking the development process to IND and beyond. Register here: https://lnkd.in/g6W_cUiK #CDMO #CRO #biologics #drugdevelopment #drugsubstance

Since twenty years MSVision is known as a developer and manufacturer of dedicated high mass and #nativeMS solutions for protein and biologics characterization. In the past these were bases on Waters QTOF and Synapt technology but in 2023 we finally introduced our new NativeQE upgrade for ThermoFishers' QExactive platform. How could such an upgrade be beneficial for you? Well, it gives you extended mass range, e.g. the tetramer in the picture would not be visible on a QExactive due to mass range restrictions. It allows you to perform charge reduction reactions to increase the difference between charge states for better selection and deconvolution and it offers optimized conditions in the HCD cell for improved fragmentation of large molecules. Basically it converts a QExactive into a useful instrument for intact #biologics characterization! And what's the NativeQE's benefit over QExactive UHMR? Well, it is MUCH cheaper, it is field upgradable in on your existing QExactive systems (restrictions apply on some models, please check for details) and it optimizes the performance where you need it most, not at m/z 60.000 where there are virtually no ions... For more information on NativeQE, visit our website https://lnkd.in/d-ScB-pS or email us at info@msvision.com! #massspec #massspectrometry #LCMS #antibody

CONTAMINATION CONTROL STRATEGY - QRM IN PRACTICE As promised, here is the description of the newest SKILLPAD - digital learning for life sciences e-Lesson (Digital Learning Module) describing practical "HOW" aspects of Annex 1 and your Contamination Control Strategy. For additional screenshots and description, check here: https://lnkd.in/eVxF5AjN Schedule your DEMO now, by contacting us at info@skillpad.com #annex1 #contaminationcontrol #gmp #pharma #biologics #bioprocessing #cgt #atmp #biotech #lifesciences #qrm

Our next-generation, scalable BEVS manufacturing platform was specifically designed to enhance productivity and streamline regulatory approvals for the production of AAV gene therapies and VLP vaccines, by delivering: – High productivity – exceptional cell growth and expression yields – Robust process and scale-up consistency – 100% chemically defined media – Risk mitigation – rhabdovirus-free cell line removes known adventitious agent – Streamlined regulatory approvals – complete documentation and cell line traceability This proprietary platform combines our Sf9 RV-Free rhabdovirus-free cell line and ESF AdvanCD™ chemically defined insect cell culture medium to achieve exemplary cell growth (viable cell densities >25 million per mL), impressive expression yields (as much as 5x the competition), and a greatly improved biosafety profile. Find out for yourself by ordering our Promo Pack, which is available for a limited time only and includes one vial of Sf9 cells, four one-liter bottles of ESF AdvanCD™ media, and one 20 ml bottle each of virus stabilization additive and transfection medium –  a $1,200 value for only $400! https://lnkd.in/dCY6Jiyz #AAV #VLP #vaccines #molecularbiology #bioproduction #biopharma #biopharmaceutical #pharma #biotech #BEVS #baculovirusexpression #viralvectors #advancedtherapies #cellandgenetherapy #advancedtherapymanufacturing

If you are looking to manufacture mRNA and/or LNPs, consider the following when planning for tangential flow filtration (TFF) unit operations. This is a great AppNote from Cytiva on the subject, "T-series TFF cassettes with Delta 100 kDa membranes for RNA and LNP applications". The document evaluates the performance of TFF cassettes with 100 kDa molecular weight cutoff membranes for effective tangential flow filtration of RNA and LNPs. It is very educational and also makes it easy to procure the filters you may need. https://lnkd.in/egsu7dKw #LNP #LNPs #lipidnanoparticles #PNP #PNPs #Lipids #mRNA #RNA #Biologics #pharmaceuticalmanufacturing #TFF #Filtration #molecularbiology #manufacturing #innovation #AppNote

Developing a systematic and effective approach to potency assay for biologics can be complex and challenging. Specificity, sensitivity, robustness and reproducibility amongst other factors are crucial to accurately measure the assay performance. Thorough understanding of the biological activity and MoA of the biologic is essential. Here are some essential strategies to designing a relevant potency assay: ✅ Understand the biological activity and MoA of the biologic. ✅ Choose appropriate biological material (eg. Cell lines) that reflects the intended target and mechanism of action of the biologic. ✅ Design assays that directly measure the biological activity of the biologic, rather than relying solely on surrogate markers. ✅ Ensure the assay is specific to the intended biological activity of the biologic and sensitive enough to detect changes in potency. ✅ Establish standardized protocols, reference materials, and acceptance criteria for the assay. Validate the assay to demonstrate its reliability, reproducibility, and accuracy. ✅ Address potential interfering factors such as matrix effects, assay variability, and stability of the biologic product. ✅ Ensure the assay is robust enough to be implemented in routine testing and reliable for assessing potency throughout product development and manufacturing. ✅ Conduct a risk assessment to identify potential risks to assay performance and implement strategies to mitigate them. What are some other factors to consider for potency assay development and validation? #biologics #potencyassay #regulatorycompliance #bioanalytical #gmpcompliance #gmp

🔬 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐈𝐧𝐜𝐮𝐫𝐫𝐞𝐝 𝐒𝐚𝐦𝐩𝐥𝐞 𝐑𝐞𝐚𝐧𝐚𝐥𝐲𝐬𝐢𝐬 (𝐈𝐒𝐑) 𝐢𝐧 𝐁𝐢𝐨𝐚𝐧𝐚𝐥𝐲𝐬𝐢𝐬: 𝐀 𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐆𝐮𝐢𝐝𝐞 Understanding and implementing Incurred Sample Reanalysis (ISR) is critical for ensuring the accuracy and reliability of bioanalytical methods. Our latest blog provides detailed insights into the intricacies of ISR, offering invaluable insights for professionals in the bioanalytical field. 🌟 𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: 𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐈𝐒𝐑: Ensuring the precision and reliability of bioanalytical data. 𝐌𝐞𝐭𝐡𝐨𝐝𝐨𝐥𝐨𝐠𝐢𝐞𝐬: Detailed exploration of techniques such as ELISA, q-PCR, and LC/MS. 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬: Compliance tips to meet stringent regulatory standards. 🔗 For a thorough understanding of #ISR and to enhance the quality of your bioanalytical data, read our blog: https://lnkd.in/gRsA5BTJ #bioanalysis #IncurredSampleReanalysis #RegulatoryCompliance #pharma #BioanalyticalMethods #bioanalyticalexpertise #drugdevelopment #drugs #drugdiscovery #regulatedbioanalysis #lifesciences