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What 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-47953024
Email: [email protected]
Alga Biologics: www.algabiologics.com
Next step:
Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call
Develop 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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The 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-47953024
Email: [email protected]
Alga Biologics: www.algabiologics.com
Next step:
Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call
Develop 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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In 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.bio
Email: [email protected]
Next step:
Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call
Develop 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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In biotherapeutic drug development, the journey from discovery to clinic involves navigating a labyrinth of regulatory requirements and strategic considerations, particularly in Chemistry, Manufacturing, and Control (CMC).
In this episode of the Smart Biotech Scientist, host David Brühlmann engaged with Rivka Zaibel, President and Founder of ADRES - Advanced Regulatory Services Ltd. - to demystify the regulatory intricacies of biologics development and provide actionable insights for biotech leaders.
With over three decades of experience in the biopharmaceutical industry, Rivka Zaibel highlights that understanding the regulatory landscape is crucial for the success of biologics development.
Here are three key takeaways from this episode:
Prioritize CMC Development Early: CMC (Chemistry, Manufacturing, and Controls) development is crucial in biologics. Rivka emphasizes starting early and engaging with regulatory agencies to avoid costly delays and streamline the bioprocessing journey.Understand Regulatory Differences: Different agencies (FDA vs. EMA) may have varied interpretations of guidelines. Familiarize yourself with ICH guidelines and the specific requirements of each agency to align your strategy effectively.Leverage Existing Resources: Before developing your own product pathway, explore existing European Public Assessment Reports (EPARs) and summary bases of approval for comparable products. This research can provide valuable insights into regulatory expectations and streamline your approach.For startups navigating the complexities of CMC development, Rivka highlights three critical quality and regulatory considerations essential for reaching Phase 1 trials. By embracing these key insights, biotech professionals can streamline the path to delivering innovative therapies to patients safely and efficiently.
In conclusion, as you continue your journey within the biopharmaceutical industry, let the Smart Biotech Scientist serve as your guide, demystifying the complexities and empowering you with the tools needed to thrive. Stay informed, stay proactive!
Connect with Rivka Zaibel:
LinkedIn: www.linkedin.com/in/rivka-zaibel/
ADRES - Advanced Regulatory Services Ltd.: www.adres.bio
Email: [email protected]
Next step:
Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call
Develop 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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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-quint
Ark: https://www.ark-biotech.com
Next step:
Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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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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-quint
Ark: https://www.ark-biotech.com
Next step:
Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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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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 Technologies
Traditional 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 Sizes
Personalized medicine, especially autologous cell therapy, demands highly customized approaches. With batch sizes of one patient, traditional automation becomes challenging, requiring new methodologies.
Cultivating Sensitive Cells
Modern 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 Product
Cell-based products are billion times more complex than antibodies, requiring sophisticated production, monitoring, and quality control processes.
Accessibility and Cost Challenges
High 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 Forward
Industry 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/assessment
Develop 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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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 Personalization
One 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 Design
With 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 Products
New 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/assessment
Develop 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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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-carruzzo
Bioscibex: https://bioscibex.com
Next step:
Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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-j4vhu
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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-carruzzo
Bioscibex: https://bioscibex.com
Next step:
Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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-j4vhuo6t
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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 Farahani
LinkedIn: 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/assessment
Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call.
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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 Farahani
LinkedIn: https://www.linkedin.com/in/reza-farahani-/
Catalyze AI: https://www.catalyzeai.com/
Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success:
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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 Foster
LinkedIn: https://www.linkedin.com/in/jasoncfoster
Oribiotech: https://oribiotech.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/assessment
Develop 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-j4vhuo6t
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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 Foster
LinkedIn: https://www.linkedin.com/in/jasoncfoster
Oribiotech: https://oribiotech.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/assessment
Develop 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-j4vhuo6t
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The world of bioprocess development in biotechnology is evolving at an unprecedented pace, driven by the quest for breakthrough innovations. While new technologies play a significant role, what truly sets successful innovators apart are fundamental habits that foster an environment ripe for groundbreaking discoveries.
In today's discussion, we'll delve into three essential habits that, when combined with the four habits previously discussed, can redefine your approach to bioprocess development. Additionally, we'll wrap up with a bonus tip that has the potential to revolutionize your career.
Challenge the Status Quo - In any scientific endeavor, particularly in biotech, a common pitfall is accepting established processes as the best or only methods. The fifth habit to cultivate is the continuous challenging of the status quo. When was the last time you scrutinized your standard operating procedures and wondered why they are the way they are?Embrace Continuous Learning - Innovation in biotech is characterized by rapid advancements, and staying ahead demands continuous learning. According to a 2023 EDX survey, nearly half of today's workplace skills will be obsolete by 2025, primarily due to AI advancements. Hence, the sixth habit is to never stop learning.Harness the Power of Passion - At the core of every great innovation is passion. The seventh habit revolves around the deep sense of purpose that drives scientific pursuits. Beyond the routine aspects of bioprocess development, what truly fuels your ambition?Finally, a game-changing career strategy known as Strategic Cross-Pollination Networking can significantly enhance your innovative capabilities. This goes beyond traditional networking, focusing on building connections across various domains to foster innovative solutions.
Innovation in bioprocess development is not about daily eureka moments but about the consistent application of these habits. Small, persistent efforts can cumulatively lead to transformative results in this rapidly evolving field.
If you found these insights valuable, share them with your colleagues. Ready to fast-track your product and technology development? As a strategic advisor to biotech leaders, we can help you eliminate costly delays and optimize your path to market.
Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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-j4vhuo6t
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In the fast-paced and highly regulated world of biotech development, maintaining an innovative spirit can sometimes feel like a Herculean task. Between optimizing cell culture processes and navigating strict regulatory requirements, it’s no wonder many scientists feel the weight of daily operations pressing down on their creativity. However, fostering innovation is crucial for breakthroughs in our field.
David Brühlmann shares practices that have transformed how scientists approach complex challenges in our field.
Here are the first four habits that can reshape your approach to bioprocess development.
Cultivate Deep Curiosity: Curiosity is the cornerstone of scientific discovery. However, it’s not just about a broad interest in science. The type of curiosity that drives innovation is the kind that goes beyond initial observations. It's the kind that makes you question what's happening inside the cell culture and strive to understand phenomena at a fundamental level.Connect the Dots: Innovation often comes from connecting seemingly unrelated ideas. Drawing connections between different facts or events can lead to a better understanding and new approaches to complex challenges.Embrace Calculated Risks: In a GMP environment, risk-taking may sound contradictory. However, calculated risks are essential for innovation. It's about carefully evaluating opportunities and understanding their potential impact before acting.Practice Persistence: Persistence is a key ingredient for innovation, especially during challenging times. Experimentation often involves setbacks and unexpected results, but each failure is a learning opportunity.Fostering innovation in biotech development is a multifaceted process that requires curiosity, the ability to connect dots, calculated risks, persistence, collaboration, digital tools, and continuous learning. By integrating these habits into your work routine, you can unlock new potentials and drive breakthroughs in the biotech field. Remember, breakthroughs often come from embracing the complex nature of bioprocess development and continuously exploring, questioning, and innovating.
Don't miss our next episode, where we’ll reveal the final three habits!
Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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-j4vhuo6t
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As biotechnology rapidly evolves, cell therapies are emerging as a groundbreaking frontier with the potential to transform medicine. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Armon Sharei, founder and CEO of Portal Bio, about the complexities, challenges, and future of cell therapies.
Cell therapies could revolutionize medicine in ways similar to antibiotics and vaccines. However, the current manufacturing process is costly and time-consuming.
Armon Sharei envisions a future where point-of-care production makes these therapies more accessible, even at the patient's bedside. This approach could not only benefit developed countries but also emerging markets.
Armon suggests that cell therapies could be as transformative as antibiotics and vaccines, with the potential to address complex diseases like cancer and autoimmune disorders. These therapies could precisely target tumors, correct dysfunctions in autoimmune diseases, and regenerate tissues in conditions like Parkinson's.
Key Takeaways:
Cell Therapies as the Future: Armon emphasizes that cell therapies, like antibiotics and vaccines, offer high efficacy with minimal toxicity. They can address complex diseases such as tumors and autoimmune disorders.Simplifying Manufacturing: Current manufacturing methods are expensive and slow. Portal Bio’s point-of-care approach could streamline production, reducing both time and costs.Expanding Accessibility: Making cell therapies more accessible requires technological advances as well as changes in regulatory and quality standards to lower costs and make treatments available globally.As technology advances, the future of cell therapies looks promising. Armon believes point-of-care cell therapies will bring sophisticated treatments directly to patients, transforming healthcare.
Connect with Armon Sharei
LinkedIn: https://www.linkedin.com/in/armonsharei/
Portal: https://www.portal.bio
Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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-j4vhuo6t
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Intracellular delivery is essential for advancing research and clinical applications, yet it presents unique challenges when working with different cell types and biomolecules.
In a recent episode of the Smart Biotech Scientist podcast, David Brühlmann spoke with Armon Sharei, the founder and CEO of Portal Bio, about the future of cell therapy, the hurdles of intracellular delivery, and groundbreaking innovations in drug screening.
Armon’s journey began at MIT, where his initial focus on chemical engineering evolved into a passion for cell engineering. While exploring innovative methods for introducing materials into cells, he discovered a novel mechanism: squeezing cells to temporarily disrupt their membranes, allowing materials to diffuse in.
Armon explained that optimizing delivery parameters - such as pore size and the speed at which cells pass through specialized membranes - can significantly enhance efficiency. "If you've optimized it, one time is enough," he noted. "We can get above 80% delivery and viability pretty easily for most cell types." He emphasized the importance of tailoring pore sizes to specific cell types, such as smaller pores for T cells compared to stem cells. Additionally, the flow speed of cells through the membrane is critical; moving too slowly renders the process ineffective, while moving too quickly can damage the cells.
Tune in to this episode to find out more about:
Addressing Intracellular Delivery Challenges: Portal Bio’s breakthrough technology uses mechanical deformation to open a cell’s lipid bilayer, allowing materials to diffuse in. This approach overcomes the limitations of traditional methods like electroporation or nanoparticle-mediated delivery, which often depend on molecular charge or risk damaging cells.Delivering a Wide Range of Molecules: Portal Bio’s technology is versatile, capable of delivering DNA, RNA, peptides, proteins, and more. Unlike methods tailored to specific molecules, this platform supports diverse applications. For instance, RNA operates in the cytoplasm, making delivery straightforward, while CRISPR complexes require nuclear localization sequences to enable gene editing in the nucleus.Streamlining Drug Screening: Portal Bio’s technology also revolutionizes drug screening. Traditional approaches often struggle with impermeable small molecules, leading to lengthy and uncertain drug development processes. By enabling high-throughput screening, Portal Bio accelerates the evaluation of numerous drug candidates, identifying promising options before chemical modifications are necessary.As bioprocesses grow more advanced, the demand for efficient and versatile intracellular delivery methods becomes increasingly critical. Armon’s insights underscore a transformative shift in the technologies and processes shaping the future of cell therapy and bioprocessing.
Connect with Armon Sharei
LinkedIn: https://www.linkedin.com/in/armonsharei
Portal: https://www.portal.bio
Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop 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-j4vhuo6t
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In part two of our insightful conversation, Dr. Susan Sharfstein builds on our previous discussion of developability assessment to explore how AI is revolutionizing protein manufacturability predictions.
As a Professor of Nanoscale Science and Engineering at the University of Albany, she shares groundbreaking insights from her collaboration with DeepSeq AI, demonstrating how artificial intelligence is transforming our ability to assess and predict protein manufacturability early in development.
Key Takeaways:
Discover how AI tools are enhancing traditional developability assessments by predicting protein expression and stability before entering the labLearn why integration of experimental validation with AI predictions is crucial for successful manufacturability assessment, and how industry partnerships are making this possible at unprecedented scaleUnderstand how the synergy between AI, DNA synthesis capabilities, and robotics is creating a "positive spiral" that will accelerate protein manufacturing innovationWhether you're involved in candidate selection, process development, or curious about AI's impact on developability assessment, this episode offers valuable insights into the future of protein manufacturing. Plus, Dr. Sharfstein shares invaluable career advice for emerging biotech scientists.
Join us to explore how AI is reshaping developability assessment and learn why this field continues to offer life-changing possibilities for patients worldwide.
Connect with Susan Sharfstein:
LinkedIn: https://www.linkedin.com/in/susan-sharfstein-b7552111/
College of Nanotechnology, Science, and Engineering, University at Albany: https://www.albany.edu/cnse
Next Steps:
Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop biologics 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-j4vhuo6t
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In this eye-opening episode, we dive deep into the critical yet often overlooked world of protein manufacturability with Dr. Susan Sharfstein, Professor of Nanoscale Science and Engineering at the University of Albany. As part of the broader developability assessment process, manufacturability evaluation helps determine whether a therapeutic candidate can be successfully produced at commercial scale.
Drawing from her extensive experience in bioprocessing and cell culture technology, Dr. Sharfstein reveals why seemingly promising protein candidates can fail during manufacturing—and how to spot these issues early.
Key Takeaways:
Discover why efficacy isn't enough: Learn how to evaluate protein candidates beyond clinical performance to ensure manufacturing successMaster early-stage assessment: Understand the critical parameters that can make or break successful scale-up, from cell line selection to protein foldingFuture-proof your development: Gain insights into how AI is transforming protein manufacturability assessment and what this means for process developmentWhether you're selecting protein candidates or optimizing your bioprocess, this episode offers invaluable guidance for making smarter decisions earlier in development. Join us to learn how to bridge the gap between discovery and manufacturing success.
Listen now to transform how you approach protein manufacturability and save valuable time and resources in your development journey.
Connect with Susan Sharfstein:
LinkedIn: https://www.linkedin.com/in/susan-sharfstein-b7552111/
College of Nanotechnology, Science, and Engineering, University at Albany: https://www.albany.edu/cnse
Next Steps:
Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment
Develop biologics 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-j4vhuo6t
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