Yokogawa Fluence Analytics’ Post

🎯 A complex medicine applies novel technologies that deliver or target drugs, by modification of a pharmaceutical ingredient, formulation or using a new delivery route. Examples of successful complex medicine therapies and vaccines, include Antibody Drug Conjugates (ADCs), developed for the treatment of certain cancers, and Lipid Nanoparticles (LNPs) which delivered the COVID-19 mRNA vaccines. 🧬 We have developed a comprehensive, cutting-edge evaluation platform to support the next generation of complex medicines. Our capabilities support companies along the complex drug development pathway which include: ▶️ Assays for characterisation of complex medicines ▶️ Suite of analytical techniques to understand intracellular delivery, biodistribution and pharmacokinetics ▶️ Expertise in translational science MDC could support your #DrugDiscovery. Learn more: https://hubs.li/Q02lLSPx0 #ComplexMedicines #LifeSciences

We’ve generated a lot of interest in antibody drug conjugate (ADC) linker design from our feature on Fierce Pharma. If you work on designing ADCs, our experts can greatly increase your chances of success. Check out the editorial below and let us know how we can support your ADC design journey. https://bit.ly/4auHIyK #ADC #BioconjugateTherapeutics #VectorLaboratories

In this GEN article, my colleague Christian Morello discusses the advancements in bioconjugates and their potential to revolutionize drug development for patients. ADCs stand out as one of the fastest-growing segments in this field, with many approved ADCs already making a significant impact on patients with life-threatening diseases. At Lonza, we proudly manufacture the majority of commercially available ADCs and foresee significant growth opportunities ahead. Drawing on expertise across divisions, we develop and produce all ADC components, providing an integrated offering to our customers. This comprehensive approach helps accelerate timelines and reduce complexity, ultimately aiding in the journey to commercialization. As the ADC field continues to evolve, collaboration and innovation remain key for advancing patient care and achieving better therapeutic outcomes. 

This most recent review primarily covers recent key advances in ADC history, clinical development status, molecule design, manufacturing processes, and quality control. The manufacturing process, especially the conjugation process, should be carefully developed, characterized, validated, and controlled throughout its lifecycle. The authors summarize the current challenges on ADC development and provide insightful perspectives. The corresponding author of this review article is Lan Wang who is the Head of Monoclonal Antibody Products at the Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control in China. She is also one of co-corresponding authors of another paper published in Antibody Therapeutics (2023 CiteScore: 8.7), the official journal of Chinese Antibody Society, published by Oxford University Press. The title of this paper is “Comparability strategy and demonstration for post-approval production cell line change of a bevacizumab biosimilar IBI305”. Open access to this paper at: https://lnkd.in/eNt287w9 #biologics #antibody #antibodies #antibodydiscovery #antibodytherapeutics #mab #mabs #cmc #bioprocess #biomanufacturing #processdevelopment #adc #adcs #antibodydrugconjugates #antibodydrugconjugate

🔬 In the rapidly evolving field of biopharmaceuticals, robust and efficient monitoring of monoclonal antibody (mAb) heterogeneity is crucial for ensuring product safety and efficacy. A recent study from researchers at the Indian Institute of Technology, Delhi introduces an innovative 2D-LC/MS method for simultaneous titer and charge variant estimation of mAbs. ✨ This new method combines Protein-A chromatography for titer estimation and cation-exchange chromatography for charge variant analysis in a single, streamlined workflow. By utilizing volatile salts, this technique enables seamless mass spectrometry (MS) coupling, significantly reducing the analysis time to just 15 minutes per sample. 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞-𝐚𝐰𝐚𝐲𝐬: • 🔗 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐞𝐝 𝐖𝐨𝐫𝐤𝐟𝐥𝐨𝐰: Combines Protein-A chromatography and cation-exchange chromatography. • ⏱️ 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲: Reduces analysis time to 15 minutes per sample. • 🔄 𝐕𝐞𝐫𝐬𝐚𝐭𝐢𝐥𝐢𝐭𝐲: Applicable for both innovator and biosimilar mAbs. • 🎯 𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧: Achieves high-resolution characterization of charge variants. For those involved in biopharmaceutical development, this approach offers a promising tool for more efficient and accurate mAb analysis. 🔗 https://lnkd.in/emCbjkgm #Biopharmaceuticals #MonoclonalAntibodies #MassSpectrometry #2DLC #BiotechInnovation #PharmaceuticalResearch #Biotech Deepika Sarin, Dr.Sunil Kumar, Anurag Rathore

I recently spoke to GEN about the advances in the field of bioconjugates and how these can lead to more effective drugs for patients. Being able to handle mAb, linker, bioconjugate and drug product in an integrated and streamlined way enable fast and effective registration and commercialization. At Lonza, we are able to transfer very specific and complex manufacturing processes to our assets leveraging our expertise in production, analytical development, quality assurance and regulatory affairs of antibody-drug conjugates.   Read the full feature article in GEN here: https://lnkd.in/ePd43fCY    #AHealthierWorld #PharmaceuticalManufacturing #Bioconjugates #Biotechnology

Veeda Biopharma's Strategy for Tocilizumab PK Assay Development:   At Veeda Biopharma, we tackle the complexities of developing PK assays for monoclonal antibodies like Tocilizumab with a comprehensive approach. Our strategy includes a highly specific bridging ELISA format, optimized to reduce matrix interference, and required assay range with high sensitivity. Our dedicated team of scientists has meticulously crafted this process, incorporating anti-idiotypic antibody pairs and optimizing the Minimum Required Dilution (MRD) to enhance selectivity and accuracy by ensuring consistent and reliable performance.   Beyond Tocilizumab, our expertise in developing custom assays for a wide range of compounds and therapeutic modalities. Whether you're working with monoclonal antibodies, fusion proteins, or other complex biologics, we provide tailored solutions to meet your specific needs, ensuring robust data and regulatory compliance.   For more information on how we can support your assay development needs, contact us at info.Biopharma@veedacr.com or visit www.veedacr.com.   Stay tuned for more updates and insights from Veeda Biopharma! Partners in creating a healthier tomorrow.   #Tocilizumab #PKAssay #VeedaBiopharma #Pharmacokinetics #Biopharma #DrugDevelopment #ELISA #ClinicalResearch #Biotechnology #CustomAssays

🔬 Application Note Alert! 🔬 Unlock the potential of in vitro technology to enhance your understanding of subcutaneous formulations' pharmacokinetic behavior! Our latest application note delves into an innovative "In vitro method for investigating pharmacokinetic behavior of long-acting subcutaneously injected therapeutics." 📝 Subcutaneous delivery is gaining traction for biotherapeutics, particularly monoclonal antibodies. However, navigating the intricacies of this delivery method requires precise insights. Discover how our SCISSOR technology bridges critical knowledge gaps in the SC industry. 🚀 We showcase data on various pharmaceutical motifs and detail assay format modifications, extending API monitoring from 1 day to 1 week. This expansion broadens the method's applicability significantly. Ready to make informed in vivo decisions for subcutaneous formulations? Download your copy today and revolutionize your approach to drug development! https://lnkd.in/eSetnG8c #Pharmacokinetics #DrugDevelopment #Biotherapeutics #InVitroTechnology #SCISSOR #SubcutaneousFormulations

We are highlighting a series of popular and impactful articles published in 2024 in our journal, Antibody Therapeutics (2022 CiteScore: 6.4). The title of the 6th article we’d like to feature is “Multiple approaches to reduce reconstitution time of lyophilized drug products with high protein concentration” contributed by Jeremy Guo from WuXi Biologics. Lyophilized drug products with high protein concentration often perform long reconstitution time, which is inconvenient for clinical use. Here, researchers described the following approaches that lead to reduction of reconstitution time, including adding annealing step, decreasing headspace pressure, decreasing protein concentration with reducing diluent volume, increasing high surface-area-to-height ratio of the cakes, increasing frequency of swirling and diluent temperature; which provided insights on the application of multiple strategies to accelerate the reconstitution of lyophilized drug products with high concentration, and facilitated their widespread clinical application. https://lnkd.in/eEyWW7g9 Antibody Therapeutics (2022 CiteScore: 6.4) is the official journal of Chinese Antibody Society (CAS), a non-profit, non-government global professional organization with focus upon antibody-based therapeutics. CAS’s 2024 Annual Conference will take place in Cambridge, MA, USA, on Saturday, May 11, 2024. The theme of this conference is “Beyond Borders: Advancements in Antibody-Based Therapeutics in Uncharted Territories". You are welcome to register for the conference right NOW via the following link. https://lnkd.in/ecmFPA4v   #biologics #antibody #antibodies #antibodydiscovery #antibodytherapeutics #mab #mabs #annualmeeting #annualconference

𝗔𝗻𝘁𝗶𝗰𝗮𝗻𝗰𝗲𝗿 𝗱𝗿𝘂𝗴 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝘆: 𝗜𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝘁𝗵𝗲 𝗶𝗺𝗽𝗮𝗰𝘁𝘀 𝗼𝗳 𝘃𝗶𝘀𝗰𝗼𝘀𝗶𝘁𝘆 𝗼𝗻 𝗹𝗶𝗽𝗶𝗱-𝗯𝗮𝘀𝗲𝗱 𝗳𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗽𝘂𝗹𝗺𝗼𝗻𝗮𝗿𝘆 𝘁𝗮𝗿𝗴𝗲𝘁𝗶𝗻𝗴 Pulmonary drug delivery via aerosolization is a non-intrusive method for achieving localized and systemic effects. The aim of this study was to establish the impact of viscosity as a novel aspect (i.e., low, medium and high) using various lipid-based formulations , transfersomes , micelles and nanostructured lipid carriers as well as to investigate their impact on in-vitro nebulization performance using Trans-resveratrol (TRES) as a model anticancer drug. Read more in the article. #pharmaceutical #lipidnanoparticles