Eurofins Bioanalytical Services’ Post

🔔 EFPIA - European Federation of Pharmaceutical Industries and Associations has just released a position paper on the use of Next Generation Sequencing (#NGS) for Adventitious Virus Detection in #Biological Medicinal Products "🧬. This insightful publication is the result from cross-company collaborative efforts of dedicated experts. PathoQuest is proud to have contributed to this significant work. The paper was written for scientists and regulatory specialists and provides valuable and comprehensive recommendations on analytical method validation, analytical comparability, and regulatory strategies, with the goal of facilitating the use of NGS and encouraging global alignment on expectations related to this transformative technology. Do you want to learn more and take a speed train to NGS implementation? Deep dive into the full paper to learn more ▶ https://lnkd.in/eYaZgGnG #NGS #Biotesting #ViralSafety #QualityControl #EFPIA

Understanding how your drug candidate’s ADME profile along with its impact on drug/patient safety is crucial for its success. VIMTA provides a comprehensive suite of PK/TK/Biomarker/ Immunogenicity assays to develop targeted dosing strategies for maximum efficacy and to gain insights into how the drug interacts within the body.   Our ligand binding assays and analytical platforms are tailored for large molecule bioanalysis, delivering accurate insights crucial for pharmaceutical and biotechnology research.   𝐕𝐈𝐌𝐓𝐀 𝐀𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞𝐬: ◉ Advanced Techniques (LC-MS for small molecule bioanalysis, LBA platforms such as ELISA and MSD for large molecules and biomarker platforms) ◉ Expert Team ◉ Flexibility and Customization of Service ◉ Strong Quality and Regulatory Compliance   Navigate the complexities associated with biotherapeutic bioanalysis with confidence. Contact us today at bd@vimta.com to discuss your PK/TK/Biomarker/ Immunogenicity assay needs. #Pharmacokinetics #ADME #BioanalyticalScience #Assays #Pharmaceuticals #PKTK #Biomarkers #Immunogenicity #Ligandbinding #Biopharma #Testing #CRO #VIMTA #India

You’ve run your biologics discovery program. It’s passed the engineering phase and now you’re considering how to further characterize it. Our “one-stop-shop” for expression, analytics-driven purification, characterization, and developability assessment is what you need. Our biologics team are experts in a plethora of formats, including bs-Ab, ms-Abs, cytokines, non-human antibody formats and antigens. We deliver the right biologics with acute assembly, purity, structural and biophysical characterization, and early developability assessment (non GxP). This approach helps you reach right faster on your downstream applications. Still considering your biologics discovery next steps? Look no further https://lnkd.in/e2V2UJRM #Biologics #ProteinScience #BiologicsDiscovery #DrugDiscovery #DownstreamApplications

Headed to AAPS PharmSci360 next week? Our team of experts, Dr Campbell Bunce PhD MBA, Parviz A. Shamlou, Zoe Yi Zhang, Julie Grace and Yang Wang-Smalley, will be there in booth #2711 to discuss your biologic's drug development challenges and share how our fully integrated CDMO+CRO capabilities can help you overcome them faster and with greater success.     Also, make sure not to miss our poster sessions on Monday & Wednesday: -Monday, October 21 at 3:30 PM – ‘Platform Approach for Identifying the Most Functional and Developable Bispecific T Cell Engager’ -Wednesday, October 23 at 12:30 PM – ‘EpiScreen® 2.0 Time Course Assay: A Sensitive and Data Rich Tool for Pre-Clinical Immunogenicity Testing of Biologics’ From our recently enhanced AbZelectPRO cell line development platform, offering quicker doubling times and 8g/L in high-performing titres to our comprehensive immunogenicity assessment platform, EpiScreen 2.0, our team welcomes the opportunity to discuss how our end-to-end design, development and cGMP manufacturing capabilities can help de-risk and streamline your biopharmaceutical program from discovery through to commercial product launch. Click here to schedule a meeting with our team at AAPS: https://lnkd.in/eR29rDSE   #PharmaSci360 #Bioconjugation #DrugDevelopment #CDMO #CRO #Biologics

Tackle the challenges of NGS data interpretation head-on with our comprehensive guide. Learn to navigate through massive data sets and diverse metrics with ease, ensuring your research is grounded in accuracy and depth. This guide is an invaluable tool for anyone in microbial identification and pharmaceutical manufacturing. Transform your QC with our NGS guide: https://okt.to/G3BW9X #nextgenerationsequencing #sangersequencing

Moving Medicine Forward If you plan to take your next biologica candiate from bench to patients and plan to attend the upcoming AAPS Event in Salt Lake City, join me and my colleague Campbell Bunce next week for a discussion on how Abzena can help move your medicine forward. Stay healthy and well Abzena

Advancing Innovation in Bio/Pharmaceutical Manufacturing 🧬 At Pharmaceutical Technology and BioPharm International, we’re dedicated to keeping you at the forefront of the pharmaceutical industry with cutting-edge insights, expert analysis, and actionable strategies. 🚀 As the global bio/pharma landscape continues to evolve, our mission is to provide you with in-depth coverage of emerging trends such as: Sustainability in drug manufacturing 🌱 Breakthroughs in cell and gene therapy 🧬 Innovative approaches to mRNA technology 💉 Whether you're focused on drug discovery, production efficiency, or regulatory compliance, we are your go-to resources for high-quality content that drives your business forward. 🔗 Explore more at www.pharmtech.com & https://lnkd.in/eWmzj7uc Stay informed. Stay ahead. 📈 #Pharma #BioTech #Innovation #PharmaceuticalTechnology #BioPharm #DrugDevelopment #Sustainability #CellAndGeneTherapy #mRNA #PharmaNews #Biopharmaceuticals #PharmaManufacturing

🔬 𝐍𝐞𝐰 𝐜𝐚𝐬𝐞 𝐬𝐭𝐮𝐝𝐲 𝐟𝐨𝐫 𝐀𝐐𝐛𝐃 𝐚𝐩𝐩𝐥𝐢𝐞𝐝 𝐭𝐨 𝐂𝐄 🔬 Capillary electrophoresis is a cornerstone technique for assessing monoclonal antibody (mAb) purity, crucial for ensuring the quality of biopharmaceuticals. This recent study showcases a robust application of AQbD principles to develop and validate reduced and non-reduced capillary electrophoresis methods. By leveraging Design of Experiments (DoE) and multivariate analysis, these procedures were optimized to meet stringent regulatory standards and enhance accuracy in mAb quality assessment. 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞-𝐚𝐰𝐚𝐲𝐬: 🧪 Developed CE-SDS methods for mAb purity determination under reduced and non-reduced conditions. 🔍 Implementation of AQbD and DoE frameworks ensured method robustness and reduced execution risk. 📊 The optimized procedures demonstrated high precision and accuracy, meeting regulatory guidelines. 🔗 Full text available here (behind paywall 💰): https://lnkd.in/e9btmEAm #AnalyticalChemistry #Biopharmaceuticals #QualityByDesign #MonoclonalAntibodies #CapillaryElectrophoresis #Pharma Terezie Cernosek, Ph.D., Matthew Dalphin, Ph.D., Joseph Sakowski, Sue Behrens, Peter Wunderli Catalent Pharma Solutions, Keck Graduate Institute

Today is truly special: it is my first post on LinkedIn, and my first paper in 15 years. 🔔 EFPIA - European Federation of Pharmaceutical Industries and Associations has just released a position paper on the use of Next Generation Sequencing (#NGS) for Adventitious Virus Detection in Biological Medicinal Products.✨ This insightful publication is the result from cross-company collaborative efforts of dedicated experts who want to pave the way for the implementation of this groundbreaking technological innovation. The paper was written for scientists and regulatory specialists and provides valuable and comprehensive recommendations on analytical method validation, analytical comparability, and regulatory strategies, with the goal of facilitating the use of NGS and encouraging global alignment on expectations related to this transformative technology. 🧬 🚄 Do you want to learn more and take a speed train to NGS implementation ? Deep dive into the full paper to learn more about our recommendations and feel free to share this material within your network.  https://lnkd.in/gTScwRgu 📣 Your support in spreading awareness about our publication is greatly appreciated. #NGS #ViralSafety #EFPIA

Choose Tanvex CDMO for comprehensive analytical services. The Tanvex team excels in developing and qualifying complex assays for product quality attributes and characterization analysis. What sets us apart?  -Tanvex's analytical team's ability to speed up method development while maintaining precision accuracy and other important matter attributes. - Application of the latest advancement in mass spectrometry, UHPLC to greatly reduce analysis time and increase analytical throughput. - Unmatched bioassay competencies our expertise spans a spectrum of critical techniques, including SPR (Biacore), Cell-based potency assays, ELISA, and qPCR, with individual team members boasting decades of hands-on experience. Explore analytical services: https://lnkd.in/gbyTPfM3 #biologics #cdmo #pharmaceuticalindustry #lifesciences