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

Podcast Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.**TOP 10 LIFE SCIENCES PODCAST**Are you ready to simp...

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  • 125: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei - Part 1
    Send us a textIntracellular 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-j4vhuo6t
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  • 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein - Part 2
    Send us a textIn 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-j4vhuo6t
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  • 123: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein - Part 1
    Send us a textIn 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-j4vhuo6t
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  • 122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 2
    Send us a textIn 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-j4vhuo6t
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  • 121: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 1
    Send us a textDigital 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
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Om Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.**TOP 10 LIFE SCIENCES PODCAST**Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:Master bioprocess development with confidence and clarityExcel at scale-up and manufacturing of biologicsTransform your innovative therapy and manufacturing technology into market-ready solutions fasterOptimize manufacturing costs without compromising qualityMake data-driven decisions that reduce the risk of failureI can’t wait to help you do biotech the smart way.Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.Ready to transform your biomanufacturing journey? Let's dive in!Next Steps:Book a free assessment to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/assessmentFast-track bioprocess development with expert guidance: https://bruehlmann-consulting.comVisit the Website: https://smartbiotechscientist.comEmail us: [email protected]
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