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
  • 5.0 (9)
  • 生命科学
  • 一周一更

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 call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call 🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders Accelerate biologics development with expert guidance: https://bruehlmann-consulting.com Visit the Website: https://smartbiotechscientist.com Email us: hello@bruehlmann-consulting.com

  1. 2小时前

    200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 2

    Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind. In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at Merck and guiding biotech companies through CMC development, David delivers the process control framework that transforms reactive troubleshooting into predictive manufacturing. The core truth: eighty percent of quality problems stem from twenty percent of your process variables. David shows how to identify Critical Process Parameters, implement intelligent control strategies, and leverage hybrid modeling that reduces experiments by 60-80%. With case studies from Genentech and Amgen, you'll gain the blueprint that turns QbD requirements into competitive advantage. Part 1 taught you what to build and measure. Part 2 shows you how to control your process to consistently deliver commercial-scale quality. Topics Discussed: The common pitfalls of scaling up manufacturing from bench to production, and why process control must go beyond end-product testing (02:10)Overview of the QbD framework: Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and the focus of this episode - Control Strategies for manufacturing (05:00)Identifying and monitoring Critical Process Parameters (CPPs) and their impact on quality, with real-world examples from Genentech’s monoclonal antibody platform (08:20)Structure of an effective manufacturing control strategy: Input, process, and output controls - including practical details on real-time monitoring and release testing (11:00)The role of hybrid modeling and machine learning in accelerating process optimization, and how this approach can dramatically reduce the experimental burden (13:30)Real examples of improved outcomes and efficiency through model-based control strategies, and why training and process understanding are essential for team success (16:10)A quick, actionable exercise biotech teams can use to map process risks and identify critical control points (16:55)Whether you’re part of a start-up or a large biotech firm, this episode offers clear, strategic steps for implementing QbD and improving process reliability. Don’t forget to listen to Part 1 for more on QTPP and CQA, and visit www.bruehlmann-consulting.com for additional resources. Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105 🧬 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-round Support the show

    21 分钟

  2. 2天前

    199: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 1

    Over 40% of biotherapeutic failures during clinical development stem from stability problems—and most trace back to protein aggregation that could have been prevented. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann exposes the hidden manufacturing crisis that derails promising biologics programs and delivers the systematic Quality by Design framework that elite biotech companies use to build quality into every process step. David brings two decades of bioprocess expertise from his time leading technology innovation at Merck and now guiding emerging biotech companies through CMC development as Managing Director of Brühlmann Consulting. Drawing on FDA and EMA regulatory guidance as well as landmark industry case studies he transforms complex QbD principles into an actionable roadmap for IND submission. This isn't theoretical regulatory compliance. It's competitive survival. Companies implementing these QbD foundations achieve predictable manufacturing scale-up, accelerated regulatory approval, and significant cost advantages. If your team is navigating CMC development for the first time or struggling with scale-up challenges, this episode provides the blueprint to transform process uncertainty into manufacturing confidence. What You’ll Learn in This Episode: The high clinical failure rate for biologics due to protein aggregation and stability problems, and one company’s costly lesson in the scale-up phase. (00:00)An introduction to Quality by Design (QbD)—how it differs from traditional development and why “the process is the product” in biologics. (03:09)The three foundational pillars of QbD, with today’s focus on product understanding and quality requirements. (05:46)Constructing your Quality Target Product Profile (QTPP): what to include and why starting with the patient is key. (07:05)A real-world QTPP example—the AMAP case study—and how it shaped formulation, packaging, and critical quality standards. (09:45)Defining and prioritizing Critical Quality Attributes (CQAs): measuring what truly matters for safety and efficacy. (11:50)Lessons from Roche/Genentech’s QbD journey: regulatory insights and the business value of robust CQA identification. (15:55)The “CQA Reality Check” exercise: a step-by-step method to focus your team on attributes that impact patients. (21:05)How early, candid dialogue with regulators and using management tools like the Notion CMC Dashboard can streamline the development roadmap and reassure investors. (23:30)Ready to flip the odds in your favor and make QbD your competitive edge? Stream this episode to catch actionable strategies and real-world cautionary tales that could change your CMC development playbook for good. Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105 🧬 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-round Support the show

    21 分钟

  3. 10月16日

    198: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 2

    What happens when the most complex molecules in biotech meet the organizational challenge of managing 300+ analytical scientists? The answer lies not just in the science, but in building systems that turn technical complexity into reliable delivery. In Part 2 of our deep dive with Amanda Hoertz, VP of Analytical and Formulation Sciences at KBI Biopharma, we shift focus from the molecular intricacies of ADCs to the operational mastery required to scale analytical development across multiple sites. Amanda reveals how her team achieves consistency across hundreds of scientists while maintaining the agility to pivot priorities in real time when critical programs need emergency support. This isn't just about managing people; it's about architecting systems that preserve institutional knowledge, accelerate method transfer, and deliver results when regulatory deadlines loom. What you'll discover: Seamless Project Handoffs Without Knowledge Loss: How KBI's stable team assignments eliminate the costly learning curves that plague most CDMO relationships, ensuring your molecule expertise stays with your program from development through commercial manufacturing.Organizational Scale Without Operational Chaos: The decision tree and layered reporting structure that allows 200+ analysts at a single site to function as a coordinated force, capable of rapid reprioritization and flood-level resource deployment when programs reach critical status.Digital Transformation That Actually Works: Beyond the automation buzzwords, Amanda walks through the practical realities of LIMS/ELN implementation, audit-compliant systems, and machine learning databases that transform raw data into defensible, actionable insights for complex biologics.Whether you're evaluating how analytical capabilities scale with program complexity, or seeking practical insights into leading technical teams through digital transformation, this episode delivers the operational intelligence that separates successful ADC programs from expensive failures. Connect with Amanda Hoertz: LinkedIn: www.linkedin.com/in/amanda-hoertz-3aba605 KBI Biopharma: www.kbibiopharma.com KBI Portal: www.standalone.kbi.bio Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call 🧬 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-round Support the show

    22 分钟

  4. 10月14日

    197: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 1

    What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely? Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to handle. In this deep-dive episode, David Brühlmann sits down with Amanda Hoertz, Vice President of Analytical and Formulation Sciences at KBI Biopharma, where she oversees 300+ scientists across the mammalian network. Amanda's team has cracked the code on some of the industry's most challenging ADC programs, achieving a remarkable 93% batch success rate by rejecting cookie-cutter approaches in favor of molecule-specific development strategies. What you'll discover: The Platform Fallacy: Why treating ADCs like standard monoclonals is costing companies millions and months of development time, and the bespoke analytical framework that's changing everything.Cytotoxic Payload Management: From free drug analysis to employee safety protocols, Amanda reveals the hidden complexities of handling molecules designed to kill cells, including the specialized facilities and analytical methods required for GMP manufacturing.Charge Heterogeneity Mastery: The analytical method that "keeps Amanda up at night," and the development strategies her team uses to achieve robust separation and qualification across multiple sites and analysts.This episode delivers the technical depth and strategic insights that bioprocess engineers need to navigate ADC development successfully. Whether you're evaluating CDMO partnerships, optimizing analytical methods, or scaling complex conjugates, Amanda's proven strategies will transform your approach to these game-changing therapeutics. Ready to master the analytical complexities that make or break ADC programs? Connect with Amanda Hoertz: LinkedIn: www.linkedin.com/in/amanda-hoertz-3aba605 KBI Biopharma: www.kbibiopharma.com KBI Portal: www.standalone.kbi.bio Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call 🧬 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-round Support the show

    26 分钟

  5. 10月9日

    196: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 2

    What if solving tomorrow’s bioprocessing challenges meant questioning the very physics of chromatography and reimagining downstream processing from the ground up? For years, large biomolecules like viral vectors and exosomes have squeezed through the limitations of traditional chromatography, leaving scientists to wrestle with capacity trade-offs and slow mass transfer. But what if a fundamental shift could unlock breakthroughs for gene therapies, vaccines, and advanced biologics? In this thought-provoking episode, host David Brühlmann sits down with Alois Jungbauer, professor emeritus of downstream processing at BOKU University (Vienna) and scientific advisor at BioChromatographix International. Together, they examine the future of chromatography and downstream processing, exploring innovations that tackle the challenges of modern gene therapy, advanced therapeutics, and sustainability in manufacturing. Alois shares his perspective on anticipating industry needs, the importance of mentorship, and why the physical limits for purification of large biomolecules are yet to be reached. Episode Highlights: The difference between solving current problems and anticipating the needs of the next generation in biotech (00:00)The promise and technical details of monolithic chromatography and its application for large modalities like gene therapy vectors and exosomes (03:01)Explanation of “inverted morphology" and AXISFLOW™ in new chromatography materials (03:18)Challenges and opportunities in continuous gene therapy vector production, and why it’s not widespread yet (07:40)The critical role of sustainability in downstream processing, particularly water usage and its impact on the viability and costs of distributed manufacturing (10:30)The relationship between reducing water consumption, manufacturing footprint, and cost of goods (12:16)Advice on scientific career development: listening, reading, understanding future industry needs, finding a mentor, and having persistence (13:50)Broader reflections on the value of science, societal perceptions, and science communication in today’s world (17:34)Alois’s key takeaway: downstream processing for gene therapy has not yet reached its physical limits—there is still significant room for improvement (20:26)If you’re looking for fresh strategies to tackle the bottlenecks of large-molecule purification - and a candid perspective on where the real opportunities and societal responsibilities lie - you won’t want to miss this conversation. Connect with Alois Jungbauer at leading conferences, including Bioprocessing Summit and Bioprocessing International, or find the next integrated continuous biomanufacturing event where he’s co-chairing. Connect with Alois Jungbauer: LinkedIn: www.linkedin.com/in/alois-jungbauer-14984811 Website : www.biochromatographix.com Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at 🧬 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-round Support the show

    25 分钟

  6. 10月7日

    195: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 1

    In this episode, host David Brühlmann is joined by Alois Jungbauer, Professor Emeritus at BOKU University, Vienna, and Scientific Advisor at BioChromatographix International. With over 40 years in bioprocess engineering and more than 400 published papers, Jungbauer offers a unique perspective on how downstream processing and purification technologies have evolved and where they’re headed next. Alois shares his unconventional journey into the world of biotech, starting from humble beginnings on an Austrian farm, and discusses key turning points that have shaped the industry. Together, they explore the latest challenges triggered by high cell culture titers, new therapeutic modalities, and the drive for automation and process integration in manufacturing. In this episode: Why the gap between upstream and downstream processes remains a core bottleneck (03:27)How rigid and convective chromatography materials changed throughput and efficiency (06:56)The shift in purification strategies with skyrocketing titers in cell culture (08:43)Automation and integrated biomanufacturing: their role in making processes more robust and continuous (10:20)Misconceptions around resin costs in full-scale versus clinical-scale manufacturing (12:10)What automation and process monitoring mean for real-time release and factory scheduling (14:05)The resurgence and application of displacement chromatography for gene therapy vectors (15:49)Whether you’re deep into process development or just curious about the next wave in biotech manufacturing, Alois Jungbauer’s insights offer valuable context for the road ahead. Connect with Alois Jungbauer: LinkedIn: www.linkedin.com/in/alois-jungbauer-14984811 Website : www.biochromatographix.com Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105 🧬 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-round Support the show

    21 分钟

  7. 10月2日

    194: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 2

    What if the future of affordable, life-changing cell and gene therapies comes down to one critical yet often overlooked factor: manufacturing efficiency? In advanced therapy medicinal products (ATMPs), groundbreaking science abounds, but the path to the clinic is still strewn with bottlenecks, especially when it comes to cost, complexity, and safety. While the promise is enormous, most therapies remain out of reach for many patients due to high cost of goods and logistical hurdles. What can actually break down these barriers and democratize access? In this episode, David Brühlmann welcomes Lucas Chan, celebrated Fellow of the Royal Society of Biology, advisor to Singapore's Ministry of Health, and a true pioneer in viral vector manufacturing. In Singapore, he founded CellVec Pte Ltd – APAC’s first regulatory accredited Viral Vector specialist CDMO. Lucas's leadership spans founding ventures in emerging markets to championing game-changing innovations in gene transfer, always with an eye toward efficiency, safety, and accessibility. Having returned “back to the bench” in collaboration with the National University of Singapore while launching his consultancy, Lucas brings both visionary perspective and hands-on experience to one of biotech’s toughest challenges. Here are three reasons why you need to listen to this episode: Efficiency is Everything: Lucas dissects how complex processes and outdated manufacturing paradigms are driving up the cost of cell and gene therapies and shares real-world advances, from transitioning viral vector production to stable producer cell lines to the emergence of non-viral gene transfer modalities, that are poised to rewrite the rulebook on scalability and affordability.Leadership Amid Complexity: Learn from Lucas’s top leadership advice drawn from his CSO and CDMO tenure: inspire teams by connecting every task to the larger mission. In a multidisciplinary, high-stakes environment, alignment and motivation aren’t just nice, they’re essential for innovation.Entrepreneurship and Community: Thinking of turning your biotech expertise into a startup? Lucas underscores the value of learning from others’ journeys, collaboration, and the insight that “it takes a village” when translating advanced therapies from bench to bedside, especially in emerging markets with unique affordability challenges.Want to transform your approach to cell and gene therapy manufacturing or just need inspiration to push your biotech project to the next level? Tune into this episode for practical insights, candid leadership lessons, and a renewed sense of what’s possible when we challenge the status quo together. Connect with Lucas Chan: LinkedIn: www.linkedin.com/in/lucaschangt Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105 🧬 Stop second-guessing your CMC strategy. Our CMC strategy accelerator identifies critical roadmap gaps that could derail your timelines and gives you the clarity to build a submission package that regulators approve. Secure your spot at https://stan.store/SmartBiotech/p/derisk-cmc-development Support the show

    19 分钟

  8. 9月30日

    193: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 1

    Viral vectors are the backbone of cutting-edge cell and gene therapies, delivering life-altering treatments to patients with genetic diseases. But making these biological delivery vehicles is a high-wire act: unpredictable, complex, and fraught with hurdles that traditional biologics manufacturers have never faced. While the world races toward next-generation therapies, the challenge of producing viral vectors at clinical and commercial scale threatens to leave patients waiting on the sidelines. Our guest on the Smart Biotech Scientist Podcast is Lucas Chan, a molecular and cell biologist with over two decades of hands-on experience in cell and gene therapy development. From his formative research at Imperial College London, where he pioneered novel viral vector cell lines, to building the UK’s first GMP clinical viral vector core and later founding CellVec Pte Ltd Asia Pacific CDMO in Singapore, Lucas is the go-to architect for manufacturing viral vectors where infrastructure barely exists. Along the way, he’s faced and overcome challenges few others could imagine. Here are three reasons this episode is a must-listen: Viral Vectors Demystified: Lucas breaks down a common misconception: viral vectors aren’t malignant viruses, but genetically disarmed delivery vehicles that can’t revert or replicate, making them safe tools for gene therapy.Manufacturing Mayhem Made Manageable: Unlike monoclonal antibodies and other biologics, viral vectors (and other cell and gene therapies) are made in living cells, leading to a level of process unpredictability and complexity where “everything, everywhere, all at once” applies. Success hinges on scientific acumen and attention to even the smallest detail, from raw materials to equipment parameters, to ensure patient safety and product quality.Pioneering in Uncharted Territory: Moving from London to Singapore, Lucas faced not just technical but regulatory and logistical challenges to founding Asia-Pacific’s first CDMO dedicated to viral vectors. His advice: engage regulators early, leverage local biomanufacturing strengths, and build multidisciplinary teams to transfer and scale bioprocess know-how.Curious how viral vector manufacturing can be reimagined to unlock the full promise of cell and gene therapies? Listen to this episode and gain unique insights into the science, strategy, and sheer determination needed to bring advanced therapies out of the lab and into the clinic. Connect with Lucas Chan: LinkedIn: www.linkedin.com/in/lucaschangt Next step: Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call 🧬 Stop second-guessing your CMC strategy. Our CMC strategy accelerator identifies critical roadmap gaps that could derail your timelines and gives you the clarity to build a submission package that regulators approve. Secure your spot at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-ready Support the show

    29 分钟
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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 call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call 🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders Accelerate biologics development with expert guidance: https://bruehlmann-consulting.com Visit the Website: https://smartbiotechscientist.com Email us: hello@bruehlmann-consulting.com

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