Fusion Scientific Laboratories Pvt. Ltd.’s Post

At WuXi XDC, we leverage in-house expertise and state-of-the-art analytical equipment to characterize the distinct intermediates and the bioconjugates including antibody drug conjugate (ADC) therapeutic candidates or diagnostic and imaging reagents at various stages of development. Methods utilized to assess and characterize these complex bioconjugated molecules such as HPLC, CE-SDS, iCIEF and LC-MS. These various methods are used for analytical assessment of drug-to-antibody ratio, free-drug content, ADC affinity, protein concentration, aggregation, pI, and peptide mapping, etc. Learn more: https://lnkd.in/gHFF4Kub   #conjugate #conjugates #bioconjugation #bioconjugate #bioconjugates #adc #adcs #antibodydrugconjugate #antibodydrugconjugates #cmc #cdmo #crdmo #biomanufacturing #bioprocessing

This recent publication introduces a novel approach to bioanalysis for oligonucleotide therapeutics (OT) using a non-ion pairing reverse phase liquid chromatography-mass spectrometry (nonIP-RP-LC-MS) method. The research provides a cost-effective 💰 and efficient ⚙️ alternative to the conventional ion pairing methods, addressing key issues such as reagent costs, memory effects, and ion suppression. This method, utilizing ammonium bicarbonate (ABC) as a mobile phase additive, demonstrates high versatility and sensitivity 🎯, making it applicable to various oligonucleotide types. 🔑 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞-𝐀𝐰𝐚𝐲𝐬: • A new nonIP-RP-LC-MS method was developed for OT bioanalysis, eliminating the need for ion pairing reagents 🧪 • The use of ammonium bicarbonate (ABC) significantly improved sensitivity and reduced issues associated with traditional methods 💡 • This method demonstrated high compatibility with different oligonucleotide types, including chemically modified variants 🌐 • The developed approach provides a broad dynamic range and sensitivity suitable for OT bioanalysis in reconstituted plasma 📊 #Bioanalysis #OligonucleotideTherapeutics #LCMS #ScientificInnovation #Pharmaceuticals Yoshiharu Hayashi and Yuchen Sun

Thanks for sharing this one, Arnaud Delobel, Ph.D. The idea here is simplicity. Less additives, less reagents, less mobile phase formulation, less ion suppression due to additives, and all the key takeaways listed below by Arnaud. One other thing that you might notice isn't present: chelating agents to block metal active sites. Oligonucleotides are well known to stick to metal surfaces and separations scientists often resort to adding things like EDTA to their mobile phase to eliminate these metal-analyte interactions. Anyone that was present for Claus Rentel's plenary talk at HPLC 2024 learned all about this. Ionis Pharmaceuticals, Inc. utilizes EDTA all around the world at their various manufacturing sites for the analysis of their oligos. Or, as is the case in this paper: eliminate your metal problem right from the start. The authors utilize a YMC Accura column. These columns are coated by SilcoTek Corporation to provide an inert, metal-free fluidic path.

GTxResolve SEC Columns offer high resolution, low adsorption, and robust performance for analyzing lipid nanoparticles (LNPs), nucleic acids, and viral vectors. They enable accelerated aggregate and size variant analysis, reproducible data for platform methods, and cost savings through their long shelf life. Additionally, these columns achieve low secondary interaction and provide low adsorption hardware, enhancing recovery for biologics. https://bit.ly/4ch20w2 #cellandgenetherapy #viralvectors #lipidnanoparticles #aggregateanalysis

💊Tow major trends transform the landscape of peptide therapeutics dramatically 👇🏽👇🏽👇🏽 ⭐ Chemical or display screening platforms become state-of-the-art for target-based drug development, resulting in a significantly enriched preclinical pipeline. ⭐ The success of GLP-1 analogs for weight loss and obesity treatment is moon-shooting the pharmaceutical relevance of peptides, causing a shortage of external synthesis capacity. 👉🏽 The performance of novel drug development projects hinges on a seamless transition from screening to the clinics. A critical component is the synthetic in-house capability to rapidly scale up and improve peptide quality in parallel, along with the ability to adopt complex chemistry to advance the stability and efficacy of your lead compounds. ⏳ The clock is ticking. It's crucial to equip ourselves with the right manufacturing tools to stay ahead of the curve in peptide therapeutics. 💡 We value your insights and invite you to join us at #Tides2024 at booth #419. Let's explore how our PurePep solutions can elevate your peptide projects together. 📅 We invite you to learn more about us and book a meeting now! https://lnkd.in/dH4BnMwJ

😊Excited to announce our participation at the prestigious TIDES USA conference in Boston, where top industry leaders come together to discuss advancing Oligonucleotide & Peptide Therapeutics to market. Meet our CMC expert, Paris H., who will be available to share insights on product development, including technical and regulatory support. Let us assist you in achieving your next milestone by offering expertise in all aspects of CMC development. 💊 ❇️What is the appropriate quality of raw materials to be used in the synthesis? ❇️Is our current level of analytical method qualification sufficient for impurity profiling and characterization? ❇️What level of characterization or data (for API/linker/modifications) is needed for the regulatory submission? Meet us: https://lnkd.in/e-TQfP7c Alexandra Beumer Sassi, PhD, RAC, Paris H., Nicole Cohen, Valérie ARNAUDINAUD-LIGNIER, Ioana Venet #TIDESUSA #pharmaconference #marketapprovalacceleration

The USP recently released a draft of Chapter 1132.1 (comments now under review) "Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry" covering the identification and quantitation of HCPs using MS. Looking for an expert to advise on how MS could benefit your analytical HCP strategy? We've got you covered: https://lnkd.in/dty8fRFF

Use of Raman Spectroscopy and PCA for Quality Evaluation and Out-of-Specification Identification in Biopharmaceutical Products In the present study, Raman spectroscopy, coupled with Principal Component Analysis (PCA), has proven to be an excellent tool for characterizing protein-based products. Notably, it offers the advantages of being minimally invasive, rapid and relatively insensitive to water. Therefore, it was successfully employed to discriminate between various stresses impacting a monoclonal antibody (mAb). The molecule used in this study is a fully human IgG1 fusion protein. Thermal stress was induced by incubating the samples at 50 °C for one month, while oxidative stress was induced by introducing hydrogen peroxide. Additionally, dilutions were performed to explore a broader range of protein concentrations. https://lnkd.in/gAfN-S87 #aspenalert #biotech #bioprocess

🔬 Ion Exchange Chromatography in Monoclonal Antibodies Purification 🧬   Ion-exchange chromatography (IEX) is a key technique used in protein purification and charge heterogeneity analysis, widely applied in the biopharmaceutical sector for the development and production of protein therapies. This technique enables the efficient removal of impurities, such as host cell proteins (HCPs) and aggregates, while maintaining the appropriate isoform profile, which is crucial for ensuring product safety and efficacy.   IEX is particularly valued for its wide range of applications, ease of scalability, cost-effectiveness, and high-throughput potential. The separation process relies on interactions between charged proteins and the oppositely charged stationary phase, utilizing the amphoteric properties of proteins, which allow separation based on their net charge at specific pH values.   This article provides a detailed discussion on various types of ion-exchange chromatography, their areas of application, and key factors for ensuring optimal method performance. The authors are our top experts in this area: ➡️ Małgorzata Urbaniak, Senior Specialist in Physicochemical Analytical Methods ➡️ Piotr Miłek, Specialist in Physicochemical Analytical Methods ➡️ Anna Morawska, Junior Downstream Process Specialist   🔗 Want to learn more? Click here https://lnkd.in/dC6k8MwM   #IEX #chromatography #Mabion #CDMO #downstream #processing #protein #purification

Keeping track of and measuring host cell proteins (HCPs) during the production of biotherapeutics is vital for maintaining the quality, stability, and safety of the product. The use of liquid chromatography–mass spectrometry (LC–MS) analysis has become a key method for the identification and measurement of specific HCPs. In this recent paper from scientists at Merck, they utilize the Evosep One coupled to a Bruker Daltonics timsTOF Pro 2 to overcome the challenges of host cell protein (HCP) analysis. By leveraging diaPASEF, they were able to reveal the presence of more than 600 additional HCPs previously missed by DDA PASEF, and reduce carryover while increasing the overall throughput. #hcp #proteomics #biotherapeutics #diapasef