Siddharth Jadeja’s Post

Here Starovoit et al describes a methodology to overcome in high temperature in column artifacts for LCMS peptide analysis 🛎Overview: High-temperature liquid chromatography (HTLC) has an important drawback. In that peptides can go unwanted modifications due to the exposure to high temperature and an acidic mobile phase while on the column 🎯Summary: Starovoit et al method employs a trapping column which is maintained at a lower temperature to keep peptides safe for a considerable amount of time before they finally elute from the separation colum. Starovoit et al observed increased peak capacity by 1.4-fold within a 110 min peptide mapping of trastuzumab and provided 10% more peptide identifications in exploratory LC–MS analyses compared with analyses conducted at 30 °C Futhermore Starovoit et al observed method reduced temperature-related artifacts by 66% for N-terminal pyroGlu and 63% for oxidized Met compared to direct injection at 60 °C. #massspectrometry #massspectrometry #biotherapeutics #biotech #chemistry #pharmacy #pharma #peptide https://lnkd.in/eGsuyQMd

ABITEC Corporation 𝗶𝘀 𝗽𝗹𝗲𝗮𝘀𝗲𝗱 𝘁𝗼 𝗮𝗻𝗻𝗼𝘂𝗻𝗰𝗲 𝘁𝗵𝗮𝘁 𝘄𝗲’𝗹𝗹 𝗯𝗲 𝗮𝘁𝘁𝗲𝗻𝗱𝗶𝗻𝗴 𝗖𝗣𝗛𝗜 𝟮𝟬𝟮𝟰 𝗶𝗻 𝗠𝗶𝗹𝗮𝗻, 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟴-𝟭𝟬 Our team will be stationed at 𝘀𝘁𝗮𝗻𝗱 𝟲𝗖𝟵𝟲 and are looking forward to meeting with colleagues and potential partners across pharma, biotech, contract manufacturing, and academia. At this year’s event we're introducing a significant addition to our services: 𝗰𝘂𝘀𝘁𝗼𝗺 𝗹𝗶𝗽𝗶𝗱𝘀 𝗳𝗼𝗿 𝗟𝗡𝗣 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀. This new capability aims to address the growing demand for ultrapure lipid chemistries required in the formulation and manufacture of lipid nanoparticle drug delivery systems. We invite you to visit our booth and explore the opportunities these chemistries offer to accelerate your drug development program, including the: - Design, synthesis, and manufacturing of ultrapure lipids specifically for LNP therapeutic applications - Custom and cGMP synthesis of ultrapure lipids - Scale up production from μg to kg for clinical trials and beyond Ahead of the event, we're interested to hear about 𝘄𝗵𝗶𝗰𝗵 𝗹𝗶𝗽𝗶𝗱 𝗰𝗵𝗲𝗺𝗶𝘀𝘁𝗿𝗶𝗲𝘀 𝗼𝗿 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗰𝗮𝗽𝗮𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝘆𝗼𝘂 𝗳𝗲𝗲𝗹 𝘄𝗼𝘂𝗹𝗱 𝗺𝗮𝗸𝗲 𝘁𝗵𝗲 𝗯𝗶𝗴𝗴𝗲𝘀𝘁 𝗶𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝘆𝗼𝘂𝗿 𝗿𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗮𝗻𝗱 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗽𝗿𝗼𝗷𝗲𝗰𝘁𝘀. Please share your thoughts in the comments. 𝗪𝗲’𝗱 𝗮𝗹𝘀𝗼 𝗹𝗼𝘃𝗲 𝘁𝗼 𝗺𝗲𝗲𝘁 𝘄𝗶𝘁𝗵 𝘆𝗼𝘂 𝗮𝘁 𝘁𝗵𝗲 𝗲𝘃𝗲𝗻𝘁. 𝗬𝗼𝘂 𝗰𝗮𝗻 𝗯𝗼𝗼𝗸 𝗮 𝗺𝗲𝗲𝘁𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝗼𝘂𝗿 𝘁𝗲𝗮𝗺 𝗵𝗲𝗿𝗲: https://lnkd.in/eERqNF88. #CPHI #CPHIMilan #LipidNanoparticles #DrugDelivery #ContractManufacturing #DrugDevelopment

Lyophilization preserves delicate formulations and therapeutic molecules, but its success depends on precise temperature control. Learn about the lyophilization process and how thermal analysis plays a critical role in this new blog: https://lnkd.in/evBGRTHe #Pharma #DrugDevelopment #PharmaIndustry

Surface Solid Dispersion of Ketoconazole on Trehalose Dihydrate using Spray Drying to Achieve Enhanced Dissolution Rate Ketoconazole (K) is a poorly water-soluble drug that faces significant challenges in achieving therapeutic efficacy. This study aimed to enhance the dissolution rate of ketoconazole by depositing spray-dried ketoconazole (SK) onto the surface of ground trehalose dihydrate (T) using spray drying. Ketoconazole-trehalose surface solid dispersions (SKTs) were prepared in ratios of 1:1 (SK1T1), 1:4 (SK1T4), and 1:10 (SK1T10), and characterized them using particle size analysis, scanning electron microscopy, powder X-ray diffraction, and in vitro dissolution studies. #pharmaceutical #excipients

𝐂𝐚𝐩𝐢𝐥𝐥𝐚𝐫𝐲 𝐄𝐥𝐞𝐜𝐭𝐫𝐨𝐩𝐡𝐨𝐫𝐞𝐬𝐢𝐬 𝐢𝐧 𝐏𝐫𝐨𝐭𝐞𝐢𝐧 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬: 𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐚𝐧𝐝 𝐏𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥 Capillary electrophoresis (CE) is a high-resolution analytical technique for protein analysis, offering high sensitivity and resolution. It’s fast, efficient, and requires minimal sample volume, making it ideal for applications in the biopharmaceutical industry. Incorporating the latest CE technology, we at nuvalore can support you in method development for your current antibody project using #CE7100 from #Agilent. #ProteinAnalytics #CapillaryElectrophoresis #Antibody #MethodDevelopment #ReaserchAndDevelopment #Pharmaceutics #ICHQ14

What happens if you allow UV light to hit your glass vial with biopharmaceutical formulation? It will degrade, of course. The question is how fast, and how to mitigate. What is surprising though is that transient reactive radicals generated during UV exposure linger for many minutes in solution, presumably continuing the damage... can see it quite well using light-coupled NMR spectroscopy, with in situ sample illumination using NMRtorch. And you can use similar approach for any ICH Q1B photostability testing! Enjoy:

In this excellent new paper Lebar et. al. describe studies on a multifacted approach to understanding protein-buffer interactions in biopharmaceuticals. Quoting from the abstract: "The excipient selection process plays a crucial role in biopharmaceutical formulation development to ensure the long-term stability of the drug product. Though there are numerous options approved by regulatory authorities, only a subset is commonly utilized. Previous research has proposed various stabilization mechanisms, including protein-excipient interactions. However, identifying these interactions remains challenging due to their weak and transient nature. In this study, we present a comprehensive approach to identify such interactions. Using the   CPMG (Carr-Purcel-Meiboom-Gill) filter experiment we identified interactions of rituximab with certain buffers and amino acids, shedding light on its Fc fragment instability that manifested during the enzymatic cleavage of the antibody. Moreover, chemometric analyses of 2D NMR fingerprints revealed interactions of selected excipients with antibody fragments. Furthermore, molecular dynamics simulations revealed potential interacting hotspots without NMR spectra assignment. Our results highlight the importance of an orthogonal methods approach to uncovering these critical interactions, advancing our understanding of excipient stabilization mechanisms and rational formulation design in biopharmaceutics."

Are you in need of custom peptides or fluorescent-labeled peptides for your drug discovery projects, life sciences research, or cosmetic development? Peptide-based therapeutics have recently gained significant attention in the pharmaceutical and biotech industries due to the rise of biologics and the increasing demand for cutting-edge life science research. Whether you need simple to complex peptides, hydrophobic peptides, or multi-modified and unusual peptides ranging from 2 to 20 amino acid residues in scales from milligrams to grams, all while ensuring high quality, Orbiton is your ideal partner! Our team of highly experienced chemists adds considerable value by tackling challenging custom peptide synthesis projects based on your specific needs and requirements, all while maintaining strict confidentiality. Mail your queries at info@orbitonls.com WEBSITE: www.orbitonls.com #pharma #research #customsynthesis #CRO #biotech #peptide #manufacturing #orbiton #chemistry #syntheticChemistry #discovery #drugdiscovery #orbitonlifesciences #lifesciences #chemicals #APIimpurities #api #CRAMS #enzymes

⚙️🔍 Enhancing Protein A Chromatography Resin Screening with Computer-Aided Design Space Identification 🧬🔧 The increasing demand for monoclonal antibodies (mAbs) in the biopharmaceutical sector highlights the importance of refining production processes, such as Protein A affinity chromatography, crucial for mAb purification. Traditionally, the screening of Protein A resins hasn't fully considered process flexibility, vital for accommodating variations in feed streams. 📊This interesting study by Steven Sachio , Blaž Likozar , Cleo Kontoravdi  and Maria Papathanasiou introduces a model-based approach combined with machine learning for the identification of design spaces, focusing on the performance and flexibility of processes for Protein A chromatography resin screening. Key Features: 🧪 Targeted Resin Screening: Assesses five significant Protein A resins, factoring in process adaptability. 💻 Machine Learning Integration: Offers a systematic approach to design space identification, enhancing process evaluation. ⏳ Efficient Design Exploration: Facilitates rapid discovery of extensive design spaces, streamlining the screening process. 🔄 Focus on Flexibility: Aims to design processes resilient to feed stream variations, improving production stability. 📚 Link to Publication: https://lnkd.in/dE52VSC6 #ProteinAChromatography #MachineLearning #DesignSpaceIdentification #Biopharmaceuticals #ProcessOptimization #PolyModelsHub

Need an expert solution to transform your delicate ADC molecule into a quality product? Benefit from our ADC experience and partner with us from ADC to drug product. ProJect Pharmaceutics is a CRO specialized in formulation and lyophilization process development for antibody-drug conjugates. We have been developing ADCs in our dedicated safety laboratories for > 13 years and have seen all generations of ADCs on our workbench. By combining protein formulation and process know-how with cytotoxic drug expertise the company holds unique assets to develop ADC drug products. Through implementation of all analytical methods to monitor full ADC, antibody and payload, we target a formulation that suits antibody, linker and payload to stabilize the ADC at its "sweet spot". On top we offer complementary formulation and process development of intermediate antibody (i.a. high-concentration, liquid frozen) and payload-linker bulk (i.a. formulation screening, bulk lyophilization). To learn more about our fields of expertise visit: https://lnkd.in/ecCzRUPQ #antibodytherapeutics #adc #adcs #antibodydrugconjugates #antibodies #cancerresearch #formulation #formulationdevelopment #freezedrying #preclinical #processdevelopment #lyophilization #pharmaceuticalmanufacturing