

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.**TOP 10 LIFE SCIENCES PODCAST**Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:Master bioprocess development with confidence and clarityExcel at scale-up and manufacturing of biologicsTransform your innovative therapy and manufacturing technology into market-ready solutions fasterOptimize manufacturing costs without compromising qualityMake data-driven decisions that reduce the risk of failureI can’t wait to help you do biotech the smart way.Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.Ready to transform your biomanufacturing journey? Let's dive in!Next Steps:Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-foundersAccelerate biologics development with expert guidance: https://bruehlmann-consulting.comFor sponsorship opportunities, contact us at hello@bruehlmann-consulting.comVisit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
Episodes
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Mar 20, 2025 • 20min
138: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint - Part 2
In the fast-evolving world of biotechnology, the pursuit of efficiency and faster development has never been more critical. The computational tools and models currently being integrated into bioprocessing present a groundbreaking approach that promises radical shifts in drug development timelines and capabilities.In the second part of our conversation, Yossi Quint, founder and CEO of Ark, shows us that the horizon of bioprocessing is lined with possibilities that could revolutionize biotherapeutics accessibility, cost, and speed in pharmaceutical innovations.Here are three key takeaways you don't want to miss:De-risking with Simulation: Yossi shared how simulation models can drastically reduce risks by running many scenarios before actual implementation. This approach optimizes processes, lowers costs, and speeds up the development cycle.Transfer Learning in Bioprocessing: Discover the potential of leveraging data across different types of molecules! Although challenging, the ultimate goal is to apply data learnings from one process to others, maximizing efficiency and success rates.Patient Impact & Cost Reduction: At the heart of these innovations is the goal of quicker, more affordable drug production. By slicing down on both time and costs, computational tools not only help drugs reach the market faster but also make them more accessible to patients globally.With innovation at its core, the modern trajectory of bioprocessing is not simply about reaching scientific milestones but about profoundly transforming patient care and accessibility. This synergistic blend of technology and purpose crafts a future in which the biotechnology sector not only grows but also enriches countless lives around the globe.If you are interested in this topic, here are a few standout conversations on AI’s impact on bioprocessing with some incredible experts:Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza FarahaniEpisodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma AlispahicConnect with Yossi Quint:LinkedIn: https://www.linkedin.com/in/yossi-quintArk: https://www.ark-biotech.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotechSupport the show

Mar 18, 2025 • 22min
137: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint - Part 1
The integration of AI into drug discovery has already led to groundbreaking advancements, uncovering patterns in vast datasets that were previously invisible to human researchers. Now, AI is set to revolutionize bioprocessing as well.In this episode of the Smart Biotech Scientist Podcast, Yossi Quint, founder and CEO of Ark, and David Brühlmann explore how AI and computational tools are reshaping bioprocess development. Yossi envisions a future where 90% of bioreactor experiments could be replaced by in silico simulations, dramatically accelerating time to market and increasing throughput.Key takeaways from the conversation with Yossi Quint:AI’s Role in Drug Discovery & Bioprocessing: AI is already transforming drug discovery by identifying intricate patterns across millions of data points. Now, bioprocessing is undergoing a similar revolution, as computational tools simplify and streamline complex workflows.The Power of Hybrid Models: Yossi highlights the synergy between mechanistic models and AI-driven approaches, emphasizing how AI can fill gaps where traditional models struggle—especially in understanding complex cellular behaviors.Empowering Bioprocess Teams with AI: As AI accelerates drug discovery, bioprocessing must evolve to keep pace. Yossi discusses the importance of digital transformation in ensuring bioprocess teams can meet increasing demands and drive innovation forward.With AI-driven models, hybrid simulations, and increased digitization, the bioprocessing industry stands at the cusp of a new era. The convergence of data, science, and technology promises not only greater efficiency and accuracy but also a faster path to life-saving treatments for patients in need.If you want to learn more, here are a few standout conversations on AI’s impact on bioprocessing with some incredible experts:Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza FarahaniEpisodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma AlispahicConnect with Yossi Quint:LinkedIn: https://www.linkedin.com/in/yossi-quintArk: https://www.ark-biotech.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotechSupport the show

Mar 13, 2025 • 13min
136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
Sickle cell disease affects thousands with severe daily pain. While FDA-approved gene therapies exist, their $2.2 million cost per treatment makes them largely inaccessible.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann explores five key challenges facing the bioprocessing industry in making these therapies more accessible:Moving Away from Platform TechnologiesTraditional bioprocessing relies on platform technologies for antibody production. However, new therapies require more flexible, adaptable systems that can accommodate novel modalities.Increased Personalization and Smaller Batch SizesPersonalized medicine, especially autologous cell therapy, demands highly customized approaches. With batch sizes of one patient, traditional automation becomes challenging, requiring new methodologies.Cultivating Sensitive CellsModern cell types need gentler handling than traditional CHO cells. Companies are developing innovative bioreactor technologies, from acoustic wave systems to stress-free cultivation methods.The Cell as the ProductCell-based products are billion times more complex than antibodies, requiring sophisticated production, monitoring, and quality control processes.Accessibility and Cost ChallengesHigh treatment costs remain the biggest barrier. For example, only 21,000 of 900,000 eligible patients have received CAR T cell therapy due to financial constraints.Moving ForwardIndustry leaders across academia and pharma are collaborating to overcome these challenges through innovation and cost reduction. Every improvement brings us closer to making these treatments accessible to more patients.Join us on the Smart Biotech Scientist Podcast as we explore innovative solutions to these challenges.Next step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotechSupport the show

Mar 11, 2025 • 13min
135: Beyond Breakthroughs: Making Biotherapeutics Affordable for All
In a world of rapid advancements in medical science and biotechnology, bioprocessing is at the forefront of healthcare innovation. Yet, despite remarkable progress, life-saving biotherapeutics remain out of reach for much of the global population.A staggering 80% of patients worldwide lack access to the biotherapeutics they need. While bioprocessing has made impressive strides, the high cost and slow development of these treatments create significant barriers. Addressing these challenges is critical to making innovative therapies widely available.David Brühlmann is launching a special four-part series based on his keynote at the Amphacademy, exploring bioprocessing’s revolutionary journey - from the early days of recombinant insulin to today’s groundbreaking therapies. This series will also highlight strategies to make these innovations more accessible to patients worldwide.From Standardization to PersonalizationOne major challenge is the shift away from platform technologies. Traditionally, antibodies were produced using standardized CHO cell templates and purification steps, but this approach falls short for new modalities.Personalized therapies further complicate the landscape. Autologous cell therapies, for example, require isolating, cultivating, and reinfusing a patient’s own cells. These small-batch processes are labor-intensive, less automated, and often reliant on outdated, paper-driven workflows.Innovations in Bioreactor DesignWith the rise of sensitive cell therapies, bioreactor design must evolve. Unlike CHO cells, these delicate cells require gentler handling environments. Innovations like acoustic wave bioreactors, bionic bioreactors, and specialized cell screws are emerging to optimize cell growth and improve efficiency.The Complexity and Cost of Cell-Based ProductsNew bioprocessing modalities bring greater complexity. Cell-based therapies and cultivated meats are far more intricate than traditional antibody proteins, making scaling production and ensuring quality especially challenging.High production costs further limit access. Even in regions where these therapies are approved, pricing remains a major barrier. Lowering manufacturing costs is essential to democratizing these life-saving treatments.The shift from basic recombinant proteins to complex cell-based therapeutics is just the beginning. Overcoming these challenges - scaling production, reducing costs, and managing complexity - is key to making breakthrough therapies accessible to all.Next step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotechSupport the show

Mar 6, 2025 • 17min
134: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 2
The biotechnology industry is on a transformative path. With emerging technologies and innovative ideas, bioprocessing professionals are poised to revolutionize how therapies are developed and delivered. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann continues his conversation with François Carruzzo, the CTO of Bioscibex, as they delve into the challenges and opportunities present in the biotech landscape.Bioprocess automation boosts efficiency and scalability in therapeutic production. François Carruzzo explores how automation and sensors simplify processes, cut costs, and enhance reliability - key to making biologics more accessible worldwide.Here are some key lessons Carruzzo learned on his entrepreneurial journey:Seeking and Leveraging Advice as a Startup: For biotechnology entrepreneurs, seeking the right advice is a cornerstone for success. Carruzzo discusses the significance of having a scientific advisor. He highlights the value of external perspectives in helping startups navigate strategic decisions, addressing complex challenges, and innovating effectively.The Role of Networking and Ecosystems: Startup ecosystems and networks play an indispensable role in propelling innovations within the biotech industry. Situated in Lausanne, Switzerland, Bioscibex is well-positioned within a dynamic biopharma ecosystem. Utilizing incubators and networking events, Carruzzo underscores the importance of connecting with other innovative organizations and experts, which can accelerate product development and industry relevance.Customer Engagement as a Key Driver for Innovation: Understanding and integrating the voice of the customer is pivotal in product development. Carruzzo emphasizes starting customer interactions early in the development process. Engaging with potential users before launching a prototype allows companies to tailor products that meet user needs and align with market demands.Carruzzo advises biotech entrepreneurs to validate their ideas through market research and pursue them with commitment. He highlights the challenges of innovation but emphasizes its invaluable rewards. By streamlining processes and prioritizing innovation, the biotech industry can drive progress that benefits both companies and patients worldwide.This episode highlights how breakthrough biotech innovations require strategy, regulatory expertise, and customer focus. Bioscibex’s journey exemplifies technology’s transformative power in the industry.Want to dive deeper into the startup journey and gain insights from entrepreneurs?Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 83-84: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens BayerEpisodes 81-82: Regenerating Muscles: The Future of Autologous Cell-based Therapy with Deana MohrConnect with François Carruzzo:LinkedIn: https://www.linkedin.com/in/francois-carruzzoBioscibex: https://bioscibex.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show

Mar 4, 2025 • 23min
133: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 1
Biologics manufacturing relies heavily on optimizing various stages, yet the seed train step - often overlooked - plays a critical role in determining overall efficiency. The seed train involves expanding cells from a small working cell bank to scales suitable for production bioreactors.Francois Carruzzo, Co-founder and CTO of Bioscibex, is rethinking how this process can be simplified, streamlined, and made more reliable, using a fully automated, closed system. However, the complexity of scaling introduces several risks, including handling errors, contamination, and delays that could derail production timelines.Today, seed train processes involve multiple vessels, open handling, and labor-intensive steps, all of which complicate operations. François identified two prominent challenges:Contamination Risks: Multiple open steps, such as using spin tubes, shake flasks, and wave systems, result in a heightened potential for contamination.Operational Complexity: With multiple campaigns and products running simultaneously, accommodating different media types and containers can become overwhelming.Bioscibex is on the verge of revolutionizing seed train operations with its innovative single-use bioreactor system. François shared how this system addresses traditional shortcomings:Wide Turndown Ratio: Capable of scaling from 30 mL all the way to 30 L within the same vessel, Bioscibex's rocking motion reactor eliminates multiple intermediary steps.Closed Workflow: By maintaining a fully enclosed environment, the system dramatically lowers contamination risks, making bioprocessing more reliable.Continuous Cell Expansion: Unlike traditional methods that involve batch dilutions, Bioscibex supports continuous cell expansion, ensuring optimal growth conditions with reduced downtime.Innovation in seed train processes extends far beyond mere operational efficiency. It lays the groundwork for scalable, consistent biologics production, ensuring therapies can reliably reach clinics faster.By simplifying the mundane yet critical seed train step, his innovation offers a glimpse into the future of stress-free, scalable cell expansion - a vision we’re excited to see unfold.Interested in finding out more about the progress made in cell culture? Take a listen to what our previous guests had to say about it:Episodes 117-118 - Critical Bottlenecks and Breakthroughs in Cell Line Development with Andrea GoughEpisodes 113-114: Weighing of Single-Use Bag Systems: Why Traditional Load Cells Are Holding You Back with Anders TvegaardEpisodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayConnect with François Carruzzo:LinkedIn: https://www.linkedin.com/in/francois-carruzzoBioscibex: https://bioscibex.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show

Feb 27, 2025 • 15min
132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 2
Artificial Intelligence (AI) is transforming industries worldwide, and biotechnology is no exception. In bioprocess development, AI is proving to be a game-changer, accelerating workflows, optimizing processes, and driving innovation. On the Smart Biotech Scientist Podcast, Reza Farahani, founder and CEO of Catalyze AI, shares his insights on how AI is reshaping biomanufacturing and the future of the industry.As AI continues to integrate into bioprocessing, the role of scientists is evolving. Farahani envisions a future where scientists collaborate with AI to enhance efficiency. One of Catalyze AI’s exciting innovations is an agentic root cause analysis tool, designed to automate troubleshooting. Instead of spending hours on manual analysis, scientists will receive AI-generated reports outlining probable causes of failures—allowing them to focus on high-level decision-making.What you’ll learn in this episode:Exciting Advances in AI: Farahani highlights the potential of Artificial General Intelligence (AGI)—AI that can generate ideas through analogy, much like humans do. Imagine an AI system recognizing a successful method in the petroleum industry and applying those principles to biomanufacturing. This kind of cross-disciplinary innovation could unlock groundbreaking efficiencies.Leadership Principles in AI-Driven Biotech Startups: Farahani takes an unconventional approach to leadership. Unlike corporate environments where avoiding mistakes is crucial, he encourages his team to embrace failure early on. "I want to see you make a mistake in the first month," he tells new hires. By removing the fear of failure, his team can experiment, think creatively, and drive true innovation—an essential mindset for biotech startups breaking new ground.Advice for Aspiring Biotech Entrepreneurs: Farahani’s advice is simple: find a problem, develop a unique solution, and take action. He urges scientists to identify small inefficiencies that can be scaled and optimized. Equally important is being open to failure and iterating quickly to refine solutions. Success comes from starting, adapting, and continuously improving.As we stand on the brink of a biomanufacturing revolution, the real opportunity lies in combining AI with biologics. While AI often dominates the conversation, Farahani emphasizes that biologics remain underhyped. The true breakthroughs will come from leveraging AI to solve real-world challenges in biomanufacturing, leading to significant efficiencies and industry-wide advancements.For those passionate about this field, staying connected with thought leaders like Reza Farahani and keeping up with the latest innovations is key. As AI and biologics continue to converge, the future of bioprocessing holds unprecedented potential for transformation and progress.Curious about how AI is transforming bioprocessing? Discover how industry experts are driving innovation to shape the future of this field.Episodes 111 and 112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107 and 108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerConnect with Reza FarahaniLinkedIn: https://www.linkedin.com/in/reza-farahani-/Catalyze AI: https://www.catalyzeai.com/Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at Support the show

Feb 25, 2025 • 29min
131: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 1
The real-world applications of AI in biomanufacturing are transformative. From reducing drug development timelines to optimizing production yields, AI is making biomanufacturing more efficient and cost-effective. This, in turn, enhances global access to life-saving therapies. As AI continues to evolve, its potential to drive even greater innovations in biologics manufacturing becomes increasingly promising.In the latest episode of the Smart Biotech Scientist Podcast, David Brühlmann speaks with Reza Farahani, founder and CEO of Catalyze AI, about the profound impact of AI on biomanufacturing. They discuss how AI is reshaping drug development, reducing costs, and simplifying complex biomanufacturing processes - bringing us closer to a future where life-saving drugs are as accessible as smartphones.Why You Should Tune In:AI’s Role in Democratizing Biomanufacturing: One of the core missions of Catalyze AI is to democratize the sophisticated knowledge that currently resides mostly within top pharmaceutical companies. By leveraging AI to improve bioprocess development, Farahani aims to bridge the knowledge gap between academia and industry, thereby reducing the cost and accelerating the development of new therapeutics. This democratization of bioprocess knowledge could potentially revolutionize the accessibility and affordability of life-saving drugs.How AI Optimizes Bioprocess Development: AI has the unique ability to manage and analyze complex, convoluted data sets much more efficiently than humans. Reza explains how transformer models—similar to the ones used in natural language processing tasks by ChatGPT—can be utilized to predict and optimize various steps in the biomanufacturing process. These models can learn and make predictions based on past data, enabling a significant reduction in the time and resources required for process development.Solving the Scale-Up Challenge: Scale-up remains one of the most challenging aspects of bioprocess development, often plagued by delays and inefficiencies. AI can immensely help by leveraging data from both small and large-scale biomanufacturing processes to predict optimal conditions. However, given the complexity and high cost associated with scale-up experiments, Reza envisions a future where distributed, small-scale biomanufacturing units could replace large-scale facilities. This would not only reduce costs but also enhance flexibility and resilience against process failures.AI is not just accelerating drug development—it’s reshaping the entire biomanufacturing landscape. Don’t miss this insightful conversation on how AI is driving the future of biotech.As we stand at the intersection of AI and biomanufacturing, the possibilities are limitless. With continued advancements, we may soon witness a paradigm shift where drug production becomes more decentralized, efficient, and tailored to global healthcare needs. The future of biotech is being written now—are you ready to be part of it?Interested in exploring more about AI’s impact on bioprocessing? Check out what other experts in the field are doing to drive innovation in this space.Episodes 119 and 120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 115 and 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiConnect with Reza FarahaniLinkedIn: 🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

Feb 20, 2025 • 20min
130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 2
The intricacies of tech transfer and the challenges of scaling manufacturing processes are often underestimated in the biotechnology industry. Understanding these complexities is crucial for translating innovative scientific breakthroughs into commercially viable products.In the second part of the conversation with Jason Foster, CEO of Ori Biotech, host David Brühlmann explores the complexities of cell therapy manufacturing. Their discussion highlights key challenges, including tech transfer, scale-out strategies, and the crucial role of commercial strategy alongside scientific excellence.Jason also revealed a groundbreaking approach in the cell therapy space. He detailed how Ori's IRO® platform can process multiple patient doses simultaneously, enabling treatment for 30 patients in parallel within just 1,000 square feet of clean room space. This innovative method drastically reduces clean room requirements by about 95% and facility sizes by approximately 50%, significantly cutting costs associated with building and operating large-scale facilities.As Jason emphasized, this shift not only accelerates access to groundbreaking therapies but also provides a sustainable model for scaling cell therapy production.Key Points to Remember:Integrated Approach: Scientists should look beyond their specialized areas and understand the requirements of subsequent bioprocessing stages to maximize patient impact.Technological Evolution: Advancing distributed manufacturing and enhancing in-line analytics are essential steps to revolutionize the biotech landscape.Commercial Viability: Prioritizing commercial feasibility alongside safety and efficacy in preclinical development can prevent costly late-stage setbacks.This episode of the Smart Biotech Scientist underscores the complexities and transformative potential of cell therapy manufacturing. As the industry continues to innovate, integrating commercial viability, flexibility, and advanced manufacturing solutions will be critical. By breaking down silos and fostering collaboration, we can accelerate the development of life-saving therapies—ensuring they reach patients faster and more efficiently.Connect with Jason FosterLinkedIn: https://www.linkedin.com/in/jasoncfosterOribiotech: https://oribiotech.comWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show

Feb 18, 2025 • 22min
129: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 1
One of the most urgent challenges in modern medicine is making cell and gene therapies widely accessible. These therapies, while groundbreaking in their safety and efficacy, often fall short when it comes to reaching patients. The reasons are manifold—high manufacturing costs, logistical complexities, and inefficiencies in the production pipeline.We're joined by Jason Foster, CEO and Executive Director of Ori Biotech, a company that's revolutionizing cell and gene therapy manufacturing through automation and innovative approaches.Jason sheds light on the technical bottlenecks that limit patient access to life-saving therapies and discusses how an integrated, holistic view of the development chain could make a significant difference. From the complexities of centralized manufacturing and the interconnectedness of the supply chain, to specific technical solutions Ori Biotech has developed, we explore the multi-faceted issues and potential solutions in making these advanced therapies more reachable.Here are three key takeaways from our conversation:Holistic Development Chain: Jason emphasizes the importance of integrating all stakeholders in the development chain, ensuring everyone understands what happens before and what needs to happen next to improve the overall process.Technical Bottlenecks & Solutions: We delved into various technical bottlenecks, including centralized manufacturing and logistical complexities. Jason highlighted how Ori Biotech is addressing these issues through automation and reducing manual labor, which can cut manufacturing costs by 50%.Impact on Accessibility: It's alarming that only 3-5% of patients who need CAR-T therapies have access to them. Jason's mission with Ori Biotech is to transform this narrative by enabling widespread access to these life-saving therapies through innovative manufacturing solutions.As cell and gene therapies stand poised to revolutionize cancer and rare disease treatment, the focus must shift toward overcoming manufacturing constraints. By integrating automation and aiming for decentralized models, companies like Ori Biotech offer a glimpse into a future where these revolutionary treatments are accessible to all who need them.Fascinated by Cell Therapy? Hear from top experts in these two episodes!Episodes 11 and 12: From Lab to Patient: Steve Oh’s Guide to Mastering Cell Therapy Process DevelopmentEpisodes 21 and 22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin KawamataConnect with Jason FosterLinkedIn: https://www.linkedin.com/in/jasoncfosterOribiotech: https://oribiotech.comWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show


