Luca Bolliger

As SFC Europe 2025 is in full swing in Basel, LCGC International spoke to John Reilly, Maria Kristina Parr, and Larry Miller about the important role that SFC now plays in life science analysis. Read the interview here: https://lnkd.in/gHh8X4xM

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📰 What makes Switzerland a leading hub for research and development in the life sciences?   Jérome Garcin, General Manager of BMS Switzerland, shares his perspective in the special Handelszeitung feature "20 CEOs – 20 Opinions."   He reflects on: 🔬 Switzerland’s role in advancing scientific innovation 🧬 Breakthroughs in oncology, cardiovascular, and neurological diseases 💊 How we can continue improving access to medicines for all patients   At BMS Switzerland, patients are at the center of every decision not just in words, but in practice. As Jérome Garcin explains in the interview, this means driving therapeutic innovation, accelerating access to life-saving treatments, and collaborating across disciplines to shape the future of medicine.   💡Read the full interview here: https://lnkd.in/eeMhPqXW Learn more about our work in Switzerland 👉 https://lnkd.in/dcZ794Hk #OneBMS #HandInHandForSwitzerland #BMSSwitzerland #Insight

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🔬 𝐎𝐩𝐭𝐢𝐦𝐢𝐬𝐢𝐧𝐠 𝐭𝐡𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐨𝐟 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜 𝐬𝐢𝐑𝐍𝐀 𝐚𝐧𝐝 𝐀𝐒𝐎𝐬 The pharmaceutical industry is entering a new era of precision medicine, with siRNA and antisense oligonucleotides offering promising strategies to modulate previously "undruggable" targets. However, their successful development requires overcoming unique translational and analytical challenges. This comprehensive white paper, authored by the IQ Consortium 𝑁𝑢𝑐𝑙𝑒𝑖𝑐 𝐴𝑐𝑖𝑑 𝑊𝑜𝑟𝑘𝑖𝑛𝑔 𝐺𝑟𝑜𝑢𝑝, consolidates cross-industry insights on best practices in ADME, tissue distribution, bioanalysis, and regulatory alignment for oligonucleotide-based therapies. 📌 𝐊𝐞𝐲 𝐚𝐫𝐞𝐚𝐬 𝐚𝐝𝐝𝐫𝐞𝐬𝐬𝐞𝐝 𝐢𝐧𝐜𝐥𝐮𝐝𝐞: 🔗 𝐁𝐢𝐨𝐜𝐨𝐧𝐣𝐮𝐠𝐚𝐭𝐢𝐨𝐧 • GalNAc-conjugation remains the gold standard for hepatocyte targeting, but antibody-, lipid-, peptide-, and polymer-conjugates are expanding targeting options. • Conjugation enhances delivery but requires robust analytical and manufacturing strategies to ensure safety and scalability. 🧪 𝐁𝐢𝐨𝐚𝐧𝐚𝐥𝐲𝐬𝐢𝐬 • LC-MS is increasingly preferred for its specificity in quantifying oligonucleotides and metabolites. • SL RT-qPCR and LBA offer higher sensitivity but face challenges in specificity and regulated adoption. • A fit-for-purpose approach, aligning assay design with intended use, is critical. 🔄 𝐁𝐢𝐨𝐭𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 • Unlike small molecules, oligonucleotides are metabolised by nucleases, with metabolite profiles showing strong cross-species similarity. • Pharmacologically active metabolites (e.g., AS(n-1)3′) must be assessed to inform exposure–response relationships and mitigate safety risks. 📍 𝐓𝐢𝐬𝐬𝐮𝐞 𝐃𝐢𝐬𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧 • For GalNAc conjugates, predictable liver distribution allows for streamlined preclinical studies. • For novel modalities, radiolabeled studies (e.g., QWBA, SPECT) may still be needed to map biodistribution and inform first-in-human dose predictions. 📑 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞 • Guidance remains limited and fragmented. • The IQ Consortium encourages a risk-based, platform-aware approach, leveraging established data packages for precedent chemistries and focusing resources on novel elements (e.g., linkers, conjugates). 🧠 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞-𝐀𝐰𝐚𝐲𝐬: • siRNA and ASOs require modality-specific approaches across bioanalysis, ADME, and PK/PD. • Bioconjugation strategies must balance targeting efficiency with manufacturability and safety. • LC-MS is increasingly central to oligonucleotide quantification, but hybrid platforms may be optimal. • Active metabolite profiling is essential, particularly for siRNA. • Regulatory flexibility exists, but proactive engagement and harmonisation are needed. #OligonucleotideTherapeutics #siRNA #ASO #Bioanalysis #TranslationalScience #ClinicalPharmacology #DrugDevelopment #PharmaceuticalInnovation #RegulatoryScience #ADME #IQConsortium

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[NEWS] Biocytogen Announces ADC Innovator Tubulis GmbH Has Signed Global Exclusive License Agreement for Single Antibody Biocytogen, a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that ADC therapeutics developer, Tubulis has exercised an exclusive license for the global development and commercialization of a fully human antibody developed by Biocytogen. The antibody will be applied in a novel ADC candidate proprietary to Tubulis. It is part of a previously signed research collaboration and option agreement to discover and advance antibody components for the development and commercialization of ADC products based on Biocytogen’s antibody discovery engine. The antibody was generated using Biocytogen’s proprietary RenMice® platform and features high affinity, low immunogenicity, and favorable developability. Tubulis will apply its proprietary linker and payload technologies to develop innovative ADC therapies based on this antibody, aiming to address areas of high unmet clinical need in cancer treatment. Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are very pleased that Tubulis has exercised its option, which reflects the international competitiveness and translational potential of our fully human antibody discovery platform. We look forward to seeing this antibody advance through Tubulis’ powerful ADC development engine and into clinical development to benefit patients around the world.” Jonas Helma-Smets, PhD, CSO and co-founder of Tubulis, stated: “Our goal is to drive innovation in ADC development and deliver uniquely positioned ADC therapeutics that can improve treatment outcomes to patients with solid tumors. The R&D collaboration with Biocytogen has yielded an antibody candidate that we believe fits well with our ADC technology platforms and that may support us in the development of a novel therapeutic candidate.” Under the terms of the agreement, Biocytogen will receive an upfront payment and is eligible for certain development, regulatory, and commercial milestone payments, and single-digit royalties on net sales. #Biocytogen #Tubulis #AntibodyDiscovery #RenMicePlatform #ADCTherapeutics #CancerTherapeutics #OncologyInnovation #DrugDevelopment #BiotechCollaboration #NovelTherapeutics #BiopharmaPartnerships

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