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

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תוכן מסופק על ידי David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist, David Brühlmann - CMC Development Leader, Biotech C-level Advisor, and Business Strategist. כל תוכן הפודקאסטים כולל פרקים, גרפיקה ותיאורי פודקאסטים מועלים ומסופקים ישירות על ידי David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist, David Brühlmann - CMC Development Leader, Biotech C-level Advisor, and Business Strategist או שותף פלטפורמת הפודקאסט שלהם. אם אתה מאמין שמישהו משתמש ביצירה שלך המוגנת בזכויות יוצרים ללא רשותך, אתה יכול לעקוב אחר התהליך המתואר כאן https://he.player.fm/legal.

State Secrets: Inside The Making Of The Electric State

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The Secret To Getting Inspired: Millie Bobby Brown & Chris Pratt Go Behind The Scenes 21:04

לפני 4 ימים21:04

הפעל מאוחר יותר

רשימות

לייק

אהבתי

21:04

Step into the mysterious and visually stunning world of The Electric State as host Francesca Amiker takes you behind the scenes with the creative masterminds who brought Simon Stålenhag’s dystopian vision to life. In this premiere episode, directors Joe and Anthony Russo, stars Millie Bobby Brown and Chris Pratt, writers Christopher Markus and Stephen McFeely, and producers Angela Russo-Otstot and Chris Castaldi reveal how they transformed a haunting graphic novel into an epic cinematic experience. Watch The Electric State coming to Netflix on March 14th. Check out more from Netflix Podcasts . State Secrets: Inside the Making of The Electric State is produced by Netflix and Treefort Media.…

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

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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 clarity

Excel at scale-up and manufacturing of biologics

Transform your innovative therapy and manufacturing technology into market-ready solutions faster

Optimize manufacturing costs without compromising quality

Make data-driven decisions that reduce the risk of failure

I 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 assessment to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/assessment
Fast-track bioprocess development with expert guidance: https://bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com

135 פרקים

#Science #Biology #Cell Culture Technology Innovation Aficionado #David Brühlmann: Biotech Entrepreneur #Bioprocess #Biotech #Cell Culture #Development #CMC #Manufacturing #Scale #Technology #Scientists #Innovation

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

updated לפני 5 ימים

שתפו

בית הסדרות•Feed

The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.
**TOP 10 LIFE SCIENCES PODCAST**

Master bioprocess development with confidence and clarity

Excel at scale-up and manufacturing of biologics

Transform your innovative therapy and manufacturing technology into market-ready solutions faster

Optimize manufacturing costs without compromising quality

Make data-driven decisions that reduce the risk of failure

135 פרקים

すべてのエピソード

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134: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 2 16:53

לפני 5 ימים16:53

16:53

Send us a text 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 Guo Episodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer Episodes 83-84: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens Bayer Episodes 81-82: Regenerating Muscles: The Future of Autologous Cell-based Therapy with Deana Mohr Connect 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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133: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 1 22:30

לפני 7 ימים22:30

22:30

Send us a text 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 Gough Episodes 113-114: Weighing of Single-Use Bag Systems: Why Traditional Load Cells Are Holding You Back with Anders Tvegaard Episodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier Detournay Connect 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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132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 2 14:57

לפני 12 ימים14:57

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Send us a text 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 Brandén Episodes 107 and 108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer Connect 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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131: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 1 26:55

לפני 14 ימים26:55

26:55

Send us a text 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 Guo Episodes 115 and 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti Connect 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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130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 2 20:15

לפני 19 ימים20:15

20:15

Send us a text 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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129: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 1 22:10

לפני 21 ימים22:10

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Send us a text 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 Development Episodes 21 and 22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin Kawamata 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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128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily - Part 2 17:42

לפני 26 ימים17:42

17:42

Send us a text 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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127: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily - Part 1 15:53

לפני 28 ימים15:53

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Send us a text 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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126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei - Part 2 20:31

לפני 5 weeks20:31

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Send us a text 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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125: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei - Part 1 21:35

לפני 5 weeks21:35

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Send us a text 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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124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein - Part 2 17:32

לפני 6 weeks17:32

17:32

Send us a text 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 lab Learn why integration of experimental validation with AI predictions is crucial for successful manufacturability assessment, and how industry partnerships are making this possible at unprecedented scale Understand how the synergy between AI, DNA synthesis capabilities, and robotics is creating a "positive spiral" that will accelerate protein manufacturing innovation Whether 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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123: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein - Part 1 22:35

לפני 6 weeks22:35

22:35

Send us a text 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 success Master early-stage assessment: Understand the critical parameters that can make or break successful scale-up, from cell line selection to protein folding Future-proof your development: Gain insights into how AI is transforming protein manufacturability assessment and what this means for process development Whether 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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122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 2 17:58

לפני 7 weeks17:58

17:58

Send us a text In the second part of this conversation on digital solutions in bioprocessing, David Brühlmann and Simon Wieninger, Business Manager Digital Solutions at Eppendorf Group, discuss real-world examples of labs revolutionizing their workflows through smart digitalization. From real-time data monitoring to intercontinental data sharing, Simon highlights the practical benefits and exciting future potential of digital technologies in bioprocessing. Missed Part 1? In the previous episode, Simon Wieninger from Eppendorf Group addressed data silos, cloud technology, and security in biotech. Catch up on that episode before diving into Part 2! Key highlights from the episode: Choosing the Right Tools : Simon emphasized the importance of selecting the right digital tools and technologies to focus on what brings the most value, particularly in the bioreactor space. Real-time data access, even from your mobile device while walking your dog, is now possible! Data Sharing Across Sites : Simon shared a fascinating case where a U.S.-based biotech company and their CDMO in Germany shared real-time data through the cloud, breaking down silos and enabling collaborative analysis. Imagine the possibilities for your company! Looking to the Future: We explored the exciting potential of integrating bioprocessing data with clinical outcomes, particularly in cell and gene therapy. This holistic approach can revolutionize patient care and therapy development. As Simon succinctly puts it, scientists should focus on what they do best - biology. The burden of managing digital technologies should not overshadow their primary research and development activities. With specialized tools and expert support, biotechnologists can achieve greater efficiency and innovation without getting bogged down by technological complexities. The conversation between Simon Wieninger and David Brühlmann illuminates the transformative potential of digital tools in bioprocessing. From real-time monitoring to data harmonization and cross-site collaboration, these technologies are paving the way for more efficient and innovative bioprocessing practices. By strategically adopting these tools, scientists can focus on groundbreaking research, ultimately accelerating the development and delivery of life-saving therapies. Connect with Simon Wieninger: LinkedIn: https://www.linkedin.com/in/dr-simon-wieninger-45b546182 Eppendorf Group: https://www.eppendorf.com 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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121: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 1 23:05

לפני 7 weeks23:05

23:05

Send us a text Digital transformation is reshaping industries worldwide, and biotech is no exception. With the integration of cloud technologies, AI, and data harmonization, bioprocessing is becoming smarter, more efficient, and more innovative. Catching up with digital revolutions in other sectors, biotech now stands at the threshold of tremendous change. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann sat down with Simon Wieninger, Business Manager Digital Solutions at Eppendorf Group, to discuss the digital revolution sweeping through bioprocessing labs. From bioreactors to data lakes, Simon sheds light on the urgent need for a data-driven approach in biotech and how digital transformation is set to reshape the industry. Here are the top three key takeaways: Breaking Down Silos : The importance of consolidating data in one place to facilitate better analysis and collaboration across departments. Leveraging Cloud Technology : Simon emphasized that the biotech industry is ready to embrace cloud technologies for enhanced data management. Data Security Concerns : Addressing the common misconception about cloud security, Simon reassured that robust measures are in place to protect bioprocess data, making it as secure as banking data. The move towards centralized data storage, the integration of AI, and strategic collaborations are critical steps in this journey. The industry is poised for transformation, and as Simon aptly put it, “step by step,” we can harness the full potential of these digital solutions. As biotech continues to evolve, the fusion of technology and biological science will undoubtedly lead to groundbreaking advancements, streamlining processes, and unlocking new possibilities in the field. Connect with Simon Wieninger LinkedIn: https://www.linkedin.com/in/dr-simon-wieninger-45b546182 Eppendorf Group: https://www.eppendorf.com Enjoyed this episode? Don’t miss these related discussions: Episode 100: From Raw Data to Actionable Insights: Unlocking the Power of Process Models with Fabian Feidl, co-founder and CTO of DataHow Episode 05: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov, the co-founder and COO of DataHow 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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120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo - Part 2 21:23

לפני 8 weeks21:23

21:23

Send us a text In the ever-evolving world of biotechnology, the integration of artificial intelligence (AI) and synthetic biology is driving unprecedented advancements. This transformative power was the focus of this podcast episode of the Smart Biotech Scientist , where host David Brühlmann engaged in a thought-provoking conversation with Haotian Guo, CEO and Founder of Ailurus on the role of AI in bioprocessing, the significance of wet lab validation, and the exciting future of programmable biology. The conversation with Haotian Guo sheds light on the profound impact AI is having on the field of biotechnology. AI's role as a "co-pilot" in scientific endeavors has enabled researchers to tackle complex problems with greater efficiency and accuracy. Haotian Guo shares: "AI helps us tremendously with tasks that are tedious and time-consuming for humans, such as reading and summarizing vast amounts of scientific literature. This capability allows scientists to focus on higher-order thinking and problem-solving." Key insights for this conversation: AI as Co-Pilot : Discover how Ailurus leverages AI to enhance research workflows. Haotian emphasizes using AI to read and analyze massive amounts of scientific literature, making it an invaluable co-pilot in the lab. Synthetic Biology Meets AI : Learn how synthetic biology combined with AI-driven models is opening new horizons for developing DNA designs and optimizing protein engineering. This fusion of biology and technology is proving to be a game-changer. Challenges in Biotech : Haotian candidly discusses the ongoing challenges, such as the need for wet lab validation and the high costs associated with data generation. Despite these hurdles, the potential for AI to streamline processes is immense. While the integration of AI and synthetic biology offers tremendous opportunities, Haotian Guo advises caution, particularly for those considering venturing into a biotech startup. He acknowledges the high-risk nature of startups, especially in an unpredictable economic landscape. However, he also underscores the importance of perseverance and preparedness, qualities crucial for navigating the biotech industry's challenges. In conclusion, Haotian Guo's insights paint a compelling picture of the future. The synergy between AI and biotech holds the promise of smarter, more efficient, and more accessible scientific research. By leveraging the strengths of both computational and experimental approaches, the biotech community is poised to achieve remarkable breakthroughs, transforming the landscape of healthcare and beyond. Connect with Haotian Guo: LinkedIn: www.linkedin.com/in/haotian-guo Ailurus: www.ailurus.bio Next Steps: Wondering how to develop bioprocesses 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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