Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

• 144: The Future of Biotech: Making Biotherapeutics More Accessible Faster

  Send us a textImagine a future where every patient can access life-saving therapies and sustainable, high-quality food is within everyone’s reach. In this episode of the Smart Biotech Scientist, David Brühlmann explores how innovative biotech developments are making this vision a reality.Here’s a sneak peek of the breakthroughs covered:AI-Powered Picoliter Scale Testing: Discover how companies like Triple Bar Bio are pushing the boundaries of what's possible with their innovative microfluidic technology that screens individual cells. Their approach enables rapid identification the best cell producers, paving the way for more efficient and precise bio-manufacturing.Hybrid Models for Process Prediction: Learn about DataHow's cutting-edge hybrid models that predicts process outcomes and improves product quality. Their models have demonstrated the potential to reduce the number of experiments by up to 80%.Unconventional Bioreactor Approaches: Explore an intriguing proposition – could tomorrow's bioreactors be living organisms like goats? BioSourcing is exploring the potential of transgenic goats to produce biopharmaceuticals more affordably, a concept that could dramatically lower production costs and enhance accessibility.The future of biotech is not just about technological advancement; it’s about embracing the impact these innovations can have globally. As David urges, the challenge is no longer about if these changes will happen, but how quickly we can achieve them.Stay curious, keep innovating, and be part of this exciting transformation in biotech. Your contributions and feedback could shape the next generation of breakthroughs.Listen, learn, and let us know what you think about these advancements. We can’t wait to hear from you!If you enjoyed this, here are some episodes worth listening:Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllEpisode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use DailyEpisode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesEpisodes 41-42: Revealing the Disciplined Pursuit of Less in BioprocessingNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/callDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

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• 143: Bioprocess Breakthroughs: How Smart Bioprocessing Is Democratizing Life-Saving Treatments

  Send us a textIn the rapidly evolving world of biotechnology, innovation is not just happening at the molecular level. Industry leaders are making groundbreaking advancements in bioprocessing - a crucial component in making life-saving therapies more accessible and affordable.The journey to affordable therapies starts with the production process itself. In this podcast episode, David Brühlmann sheds light on innovations in bioprocess design that are setting new standards in efficiency and efficacy. At the heart of this transformation is the shift from traditional process formats like fed-batch to continuous process formats, quality by design approaches, and the implementation of breakthrough technologies.Here's a quick rundown of the key takeaways:Revolutionary Process Designs: Industry leaders are enhancing bioprocess designs—from antibody production enhancements to integrating perfusion mode. One case study highlighted a dramatic increase in viable cell density and protein titers through intensified processes.Quality Control Innovations: Companies like Cyto-Facto are pioneering quality by design in the challenging cell and gene therapy space. By leveraging sophisticated PAT systems, they can monitor critical process parameters in real-time, ensuring consistent quality even in complex bioprocesses.Metabolite Shifts and Efficacy: A surprising discovery revealed the power of metabolite shifts induced by cell culture media design, inspired by an intriguing study on cyclists, to enhance antibody efficacy and stability. This opens new possibilities for engineering the quality of biopharmaceuticals through simple modifications in the culturing process.The innovations discussed in the Smart Biotech Scientist illustrate a pivotal transformation in bioprocessing. By rethinking process designs and committing to quality control, the biotech industry is paving the way for groundbreaking therapies that are not just dreams but realities - realities that are tangibly more accessible to patients worldwide.As we anticipate more developments in this field, the promise of biotech becomes increasingly certain: a future where life-saving treatments are affordable and available to all who need them.Catch the full episode to explore how these innovations are not just improving efficiency but making life-saving therapies more accessible globally.If you enjoyed this, here are some episodes worth listening:Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllEpisode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use DailyEpisode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesEpisodes 41-42: Revealing the Disciplined Pursuit of Less in BioprocessingNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/callDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

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• 142: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor - Part 2

  Send us a textWhat if we could revolutionize biotechnology by slashing antibody production costs by 70%? In a world where traditional mammalian cell cultures struggle with scalability and cost-effectiveness, an unexpected hero emerges from the depths of our oceans - microalgae.The use of microalgae in biotechnology is not just a novelty but a necessity, given the current demands for more efficient and cost-effective production methods. Muriel Bardor, co-founder, CEO and CSO of Alga Biologics, highlights a particularly startling statistic: microalgae can reduce the cost of antibody production by an impressive 70%. This innovation could revolutionize the biotechnology industry by making life-saving therapies more accessible.Here are 3 key takeaways from this podcast episode:Quality and Safety Assurance: By collaborating with virology experts and using advanced techniques like mass spectrometry, they ensure that their processes are virus-free and free from host-cell protein contamination. The company is paving the way for future developments despite the challenges of not having standard ELISA kits commercially available.Regulation and Industry Perception: Launching such transformative technology inevitably entwines with regulatory landscapes. Muriel and her company have begun discussions with the French regulatory agency, drawing optimism from the fact that similar plant-based products, such as glucocerebrosidase, have already paved the way in the market. This indicates a growing acceptance within regulatory bodies of alternative bioprocessing platforms, inspiring hope for microalgae's future in antibody production.Future Vision: Muriel hopes to break conservative barriers within pharmaceutical companies and promote the adoption of microalgae production. This offers not only cost-effective solutions but also holds potential for new treatment options, like for neuroblastoma.Check out the episode to hear Muriel's advice for aspiring scientists and the general public alike regarding the future of research and the well-being of our planet.Connect with Muriel Bardor:LinkedIn: www.linkedin.com/in/muriel-bardor-47953024Email: [email protected] Biologics: www.algabiologics.comNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

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• 141: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor - Part 1

  Send us a textThe world of biologics manufacturing is about to be transformed by a breakthrough that slashes antibody production costs by 70%. This revolutionary approach leverages the untapped potential of microalgae to deliver a sustainable, cost-effective solution that could make life-saving therapeutics more accessible than ever before. Enter microalgae, the star of this groundbreaking development.In this episode of the Smart Biotech Scientist, Muriel Bardor, the co-founder, CEO and CSO of Alga Biologics, shared insights into how her team's pioneering work with microalgae could redefine the landscape of immunotherapy.Here are some takeaways from her conversation with David Brühlmann:Green Revolution in Bioprocessing: Discover how microalgae can slash production costs by 70% and offer a sustainable alternative to traditional antibody manufacturing. Muriel explains how these photosynthetic organisms capture 7 tons of CO2 per kilogram of product - transforming antibody manufacturing both economically and environmentally.Rethinking Antibody Production: Learn why the conventional use of mammalian cells in antibody production is being challenged and how microalgae overcome the limitations of traditional methods, bringing life-saving drugs within reach for more people globally.Sustainable Impact: With a process that mirrors nature, Muriel’s approach sets a new standard for eco-friendly biotech production. Find out how microalgae are changing not just the industry, but our world.We invite you to listen to this insightful conversation and explore how you can apply these groundbreaking ideas to your own work. Has Muriel’s innovative approach inspired you? Share your thoughts or questions with us - we'd love to hear from you!If you are interested in antibody production, here is another episode worth listening:Episodes 47-48: Mastering Process Economics: Driving Down Costs in Antibody Production with Brian KelleyConnect with Muriel Bardor:LinkedIn: www.linkedin.com/in/muriel-bardor-47953024Email: [email protected] Biologics: www.algabiologics.comNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

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• 140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 2

  Send us a textIn this episode, we explore the important steps in preparing for regulatory meetings, address the dangers of cross-contamination in biotechnology facilities, and debunk common misconceptions that could derail your CMC development strategy.As the founder and president of ADRES - Advanced Regulatory Services Ltd., Rivka Zaibel brings over 36 years of industry experience and practical strategies to help navigate the intricacies of CMC development and regulatory compliance.Here are three key takeaways:Risk Assessment is Paramount: Start risk assessments in parallel with facility design to prevent cross contamination. Remember, areas for both mammalian and microbial cells should be segregated to ensure safety.Early Engagement with Regulatory Agencies: Don’t wait until everything is finalized before consulting with regulatory bodies. Engaging them early can ensure your plans align with their requirements and might even spark valuable advice you hadn’t considered.Understand and Plan Your Product Journey: Have a clear vision of your final product from the start, and plan backwards. This approach ensures all supporting processes are adequately addressed, saving time and preventing costly mistakes down the line.Ultimately, successful biologics development hinges on thorough understanding and strategic planning. This includes comprehensive risk assessments, early regulatory engagement, and a commitment to continuous training and facility validation.Rivka's insights offer a roadmap for navigating this complex landscape, aiming to deliver groundbreaking therapies with precision and compliance. By following these expert strategies, biotech professionals can streamline their processes, avoid common pitfalls, and ensure the successful introduction of their products to the market.Connect with Rivka Zaibel:LinkedIn: www.linkedin.com/in/rivka-zaibel/ADRES - Advanced Regulatory Services Ltd.: www.adres.bioEmail: [email protected] step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

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