EP-065 Industry Insights - Drug Fc Conjugates скачать в хорошем качестве

EP-065 Industry Insights - Drug Fc Conjugates

EPISODE 065: "Merck's $9.2B Bet on the Future - Drug-Fc Conjugates" Drug-Fc Conjugates | Pharmaceutical Manufacturing | Cidara Therapeutics | Cloudbreak Platform | Biologics Manufacturing | Antibody Engineering Explore Merck's stunning $9.2 billion acquisition of Cidara Therapeutics and discover how drug-Fc conjugates represent a revolutionary approach to medicine. This episode breaks down the molecular innovation behind CD388, a single-injection flu preventative providing six months of protection, and reveals why the Cloudbreak platform technology could reshape pharmaceutical development across infectious disease, oncology, and immunology. KEY TOPICS COVERED: Drug-Fc Conjugate Technology: How drug-Fc conjugates differ from antibody-drug conjugates (ADCs), molecular architecture combining small molecules with Fc fragments for extended half-life, click chemistry conjugation techniques, neonatal Fc receptor recycling enabling months-long circulation, immune system recruitment advantages over vaccines for immunocompromised patients CD388 Clinical Journey: 76% protection against influenza over 24 weeks from single injection, FDA Breakthrough Therapy Designation October 2025, Phase 3 ANCHOR study with 6,000 participants, activity against all influenza strains including H5N1 bird flu, Johnson & Johnson partnership to $9.2 billion Merck acquisition, neuraminidase inhibitor zanamivir conjugated to Fc fragment Cloudbreak Platform: Modular system for creating drug-Fc conjugates across disease areas, CD421 oncology program targeting CD73 tumor immunosuppression, dual-targeting conjugates combining CD73 inhibition with PD-1 blockade, polymyxin conjugates for antibiotic-resistant bacteria, 18-24 month development timelines Biologics Manufacturing: CHO cell expression for Fc production in bioreactors, multi-step chromatography purification to 99.9%+ purity, copper-catalyzed azide-alkyne cycloaddition conjugation chemistry, drug-to-antibody ratio control, GMP compliance across FDA, EMA, PMDA Cloud MES Systems: Real-time bioreactor monitoring, complete serialization from cell thaw to patient, IoT sensor integration for cold chain, AI-powered predictive analytics, rapid root cause analysis, digital twin simulation, 20% throughput improvements Industry Implications: Merck's Keytruda patent cliff preparation, global flu vaccine market disruption potential, multi-billion-dollar peak sales, antibody-drug conjugate competitive landscape ($15 billion by 2028), AI-driven process optimization, 2027-2028 CD388 commercial launch Perfect for: Pharmaceutical manufacturing professionals, biotechnology researchers, biologics specialists, quality assurance and regulatory affairs professionals, clinical development teams, supply chain managers, healthcare innovation enthusiasts Featured Companies & Technologies: Cidara Therapeutics | Merck | Johnson & Johnson | Janssen Pharmaceuticals | Apprentice.io Cloud MES Platform Host: Frank Maggiore Series: Apprentice.io Industry Insights Podcast #DrugFcConjugates #PharmaceuticalManufacturing #BiologicsManufacturing #CidaraTherapeutics #Merck #AntibodyEngineering #InfluenzaPrevention #CloudbreakPlatform #CD388 #Biotechnology #DrugDevelopment #ClinicalTrials #FDABreakthroughTherapy #AntibodyDrugConjugates #ADC #CloudMES #PharmaceuticalInnovation #BioManufacturing #GMPManufacturing #InfectiousDiseases #OncologyDrugs #Immunotherapy #AIinPharma #DigitalTransformation #RegulatoryAffairs #QualityControl** ENGAGE WITH US: Like this video if you found it valuable Comment with your thoughts on drug-Fc conjugates Subscribe for weekly science-based pharmaceutical insights Share with colleagues in pharma and biotech Learn more about cloud-based manufacturing solutions: apprentice.io Disclaimer: The content in this video podcast is for informational purposes only. The views and opinions expressed are those of the speakers and do not necessarily reflect the official policy or position of Apprentice.io or any other agency, organization, employer or company. This podcast does not constitute medical, financial, regulatory, or legal advice. Viewers should consult with appropriate professionals for specific advice. Apprentice.io makes no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability of the information contained in this video. Any reliance you place on such information is strictly at your own risk. Related Topics: antibody-drug conjugates, click chemistry, neonatal Fc receptor, neuraminidase inhibitors, zanamivir, influenza prevention, H5N1 bird flu, CD73 inhibitors, PD-1 blockade, cancer immunotherapy, antibiotic resistance, CHO cell culture, bioreactor operations, conjugation chemistry, cold chain logistics, predictive analytics, digital twins, biosimilars, Keytruda patent cliff, drug discovery platforms