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Pediatric gene therapy is rapidly reshaping what is possible for children born with rare genetic diseases. Join Dr. Rachel Abu Taleb, Medical Director, Medical Affairs at Veristat, for a look at the platforms driving clinical progress, including AAV vectors, lentiviral approaches, and CRISPR-based gene editing. Through examples such as Luxturna, Zolgensma, Casgevy, and Lyfgenia, this...
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This expert panel will discuss how digital documentation is reshaping inspection readiness. Panelists will explore the role of electronic batch records, integrated quality systems, and automated workflows in supporting compliance with ALCOA+ principles, while enabling real-time visibility and faster audit response.
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Looking for fill-finish manufacturing capacity? This webinar brings together leading CDMOs to showcase their latest sterile filling, lyophilization, and advanced packaging capabilities, along with current facility availability and timelines. Gain valuable insights into quality, regulatory compliance, and manufacturing options to help identify the right partner for your biopharmaceutical development and commercialization needs.
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Explore the latest large molecule manufacturing capabilities from leading CDMOs in this informative webinar. Learn about advances in cell line development, fermentation, purification, process optimization, and scale-up, while gaining insight into available capacity, facility locations, and timelines. Whether you're evaluating manufacturing partners or planning future biologics production, this session offers a practical overview to help...
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As cell therapies advance toward commercial-scale manufacturing, developers can face increasing pressure to balance performance, scalability, and process flexibility. Flexible modular workflows are emerging as a powerful approach for scalable cell therapy manufacturing, enabling enhanced process control, workflow adaptability, and operational efficiency while maintaining consistency across the manufacturing pipeline. These advantages can be particularly valuable... |
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Moving promising research from the university lab to the CDMO suite requires more than breakthrough science—it requires the right documentation, development strategy, and manufacturing readiness. In this Outsourced Pharma Live discussion, industry experts explore how academic innovators and CDMOs can better align earlier, build stronger technical packages, and create a smoother path to outsourced development...
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Technology transfers can introduce risk and create knowledge gaps at every stage of development, whether it’s moving a process from development to manufacturing, transferring methods between analytical labs, or onboarding a new CDMO partner. This is especially true in the development of antibody-drug conjugates (ADC), where the complexity of conjugation processes, analytical characterization, and specialized... |
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In this virtual event, leading CDMOs will share how host selection, vector design, and clone screening strategies influence manufacturability from early development through commercialization. Join us to learn what to evaluate early, how to reduce downstream risk, and how to make more informed cell line development decisions.
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1 event,
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As biopharmaceutical manufacturing becomes increasingly global, organizations face growing challenges in balancing flexibility, standardization, and scalability. CDMOs must accommodate sponsor-specific requirements, manufacturers must transfer processes across geographically dispersed facilities, and growing programs require equipment platforms that can scale without introducing unnecessary risk or complexity. Successfully navigating these challenges requires more than equipment; it requires a... |
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Cell & Gene Tech Expo offers a live virtual experience designed to empower industry professionals in sourcing best-fit solutions for their cell and gene therapy manufacturing needs. Through this series of digital sessions, attendees will have the chance to explore the newest equipment and solutions offered by our presenters, aimed at addressing the current challenges... |
2 events,
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Cell & Gene Tech Expo offers a live virtual experience designed to empower industry professionals in sourcing best-fit solutions for their cell and gene therapy manufacturing needs. Through this series of digital sessions, attendees will have the chance to explore the newest equipment and solutions offered by our presenters, aimed at addressing the current challenges...
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Join Univo IRB for a unique educational webinar that takes attendees inside the IRB decision-making process through a live mock board review. Using a fictional agenda item based on real clinical and ethical challenges, experienced IRB members will evaluate key protocol considerations including risk-benefit assessment, informed consent, participant protections, recruitment strategies, and regulatory compliance. This...
Free
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3 events,
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The journey from a successful lab result to a reliable, GMP-compliant product is rarely a straight line. It's a transition filled with technical hurdles, regulatory pressure, and the constant challenge of scaling without compromise. We created the Commercial Readiness Solutions session to help you navigate this transition. This virtual event is designed to be highly...
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Unexpected particle findings can raise critical questions about product quality, patient safety, and regulatory compliance. Join KBI Biopharma's experts to learn how clinical in-use studies and advanced particle forensics can help identify particle sources, assess risk, and build regulator-ready evidence for confident decision-making. Register now to discover practical strategies for accelerating investigations, supporting development timelines,...
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As biologics developers work to improve productivity, maintain product quality, and accelerate development timelines, traditional optimization approaches can sometimes reach a point of diminishing returns. While cell culture processes generate vast amounts of biological and process data, extracting actionable insights from that information remains a significant challenge. In this webinar, Thermo Fisher Scientific specialists discuss... |
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As biologics developers work to improve productivity, reduce development timelines, and manage manufacturing costs, traditional media optimization approaches can become increasingly resource intensive. Predictive modeling is emerging as a complementary approach that can help integrate biological knowledge, process data, and artificial intelligence (AI) to support more efficient media development. In this webinar, Thermo Fisher Scientific...
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Nanoparticle programs can stall when early formulation choices fail to hold up through scale-up, tech transfer, and manufacturing. Join leading CDMO experts on August 18 at 11:00 AM ET to learn how decisions around lipid or polymer selection, particle engineering, process design, and manufacturability can impact downstream success. Register now to gain practical insights that...
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Oral solid dose programs can run into costly scale-up challenges when early formulation and process decisions aren’t built for long-term manufacturability. Join leading CDMO experts on August 18 at 1:00 PM ET to explore how excipient selection, granulation strategy, particle engineering, and process design can impact tech transfer, validation, and commercial manufacturing. Register now to...
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How can life sciences companies developing new medicines engage the FDA successfully during a period of rapid changes in agency personnel and policies? Should companies adjust their agency communication strategies or ask new questions during meetings? Our deeply experienced panelists will discuss key changes at the FDA, how companies can get the most out of...
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Join Dr. Marco Davila to explore a novel anti-CD83 CAR-T design for relapsed/refractory AML that overcomes myelosuppression barriers. Register for the live session. Developing effective Chimeric Antigen Receptor (CAR) T-cell therapies for Acute Myeloid Leukemia (AML) remains one of the most formidable frontiers in cellular immunotherapy. Unlike lymphoid malignancies where lineage-specific targets like CD19 or... |
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A practical framework for reducing variability, minimizing manual sampling, and improving run-to-run consistency with modern UF/DF control strategies. August 26, 2026 | 11:00 AM ET Ultrafiltration Diafiltration (UF/DF) is often treated as a straightforward concentration and buffer-exchange step, but teams know the reality looks different. Small differences in setup, endpoint definition, and in-process decision-making can... |
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