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

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/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show

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/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show

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 ShareiLinkedIn: https://www.linkedin.com/in/armonsharei/Portal: https://www.portal.bioWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show

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 ShareiLinkedIn: https://www.linkedin.com/in/armonshareiPortal: https://www.portal.bioWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show

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/cnseNext 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/assessmentDevelop 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-j4vhuo6tSupport the show

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/cnseNext 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/assessmentDevelop 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-j4vhuo6tSupport the show

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-45b546182Eppendorf Group: https://www.eppendorf.comNext 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/assessmentDevelop 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-j4vhuo6tSupport the show

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 WieningerLinkedIn: https://www.linkedin.com/in/dr-simon-wieninger-45b546182Eppendorf Group: https://www.eppendorf.comEnjoyed 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 DataHowEpisode 05: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov, the co-founder and COO of DataHowNext 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/assessmentDevelop 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🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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-guoAilurus: www.ailurus.bioNext Steps:Wondering how to develop bioprocesses with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop 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-j4vhuo6tSupport the show

Biotechnology is rapidly evolving as innovation addresses real-world needs. At the cutting edge of this evolution, synthetic biology and AI-driven protein design are revolutionizing our approach to complex processes like protein purification.In this episode of the Smart Biotech Scientist podcast, host David Brühlmann talks with Haotian Guo, CEO and Founder of Ailurus, about the modern advancements in synthetic organelles and their transformative impact on protein purification.Haotian Guo introduces a groundbreaking approach inspired by nature’s processes. Instead of relying solely on chromatography, synthetic biology mimics how organelles in cells, like beta cells purifying insulin, naturally segregate and process proteins. This innovation simplifies and optimizes bioprocessing, offering a more efficient alternative to traditional techniques.Key takeaways from this conversation:Revolutionary Advances in Protein Purification: Haotian discusses the innovative use of synthetic membrane-less organelles to simplify and enhance protein purification processes, drawing inspiration from natural cellular mechanisms.Combining AI with Synthetic Biology: Learn how the integration of AI and biotechnology can accelerate advancements and create more efficient bioprocesses, unlocking potential for rapid development in biologics.Scalability and Practical Applications: Insight into how these new technologies are being scaled from lab environments to industrial applications, maintaining high purity and yield, and the potential roadblocks and solutions encountered along the way.Through innovation rooted in imitation of natural processes and amplified by the power of AI, the future of protein purification looks drastically simplified, more efficient, and scalable. Synthetic organelles represent a leap forward, challenging the age-old techniques that have long dominated the field.Companies like Ailurus are not just contributing new tools but reshaping the roadmap for bioprocess development. As we stand on the brink of these technological advancements, the collaborative synergy between synthetic biology and artificial intelligence is setting the stage for revolutionary impacts across the biotech landscape.This podcast episode is filled with eye-opening insights and practical takeaways for anyone in the biotech or pharmaceutical industries. Whether you're an academic, a seasoned industry professional, or simply curious about the field, you'll find valuable perspectives to explore.Connect with Haotian Guo:LinkedIn: www.linkedin.com/in/haotian-guoAilurus: www.ailurus.bioNext Steps:Wondering how to develop bioprocesses with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop 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-j4vhuo6tSupport the show