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

By: David Brühlmann - CMC Development Leader Biotech C-level Advisor Business Strategist
  • Summary

  • 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

    © 2025 Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
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Episodes
  • 118: Critical Bottlenecks and Breakthroughs in Cell Line Development with Andrea Gough - Part 2
    Jan 9 2025

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    In the second part of our conversation with Andrea Gough, Senior Director for Advanced Instruments’ Solentim Portfolio, we’ll explore how AI and machine learning have, in recent years, begun to transform various aspects of biotechnology, including cell line development (CLD). Andrea shares insights into how these cutting-edge technologies are being applied to the early stages of clone selection.

    AI's capability to analyze images and classify clone viability is another breakthrough. Feeding thousands of images into AI systems allows for efficient and accurate decision-making, reducing the workload on scientists.

    Here are three key takeaways from our conversation:

    • Leverage AI and Machine Learning: Integrate AI to streamline clone selection and optimize cell line development processes. AI can identify key phenotypic identifiers and predict the best clones, driving efficiency and productivity.
    • Diversify Expression Systems: While CHO cells dominate the protein therapy space, exploring alternative systems like HEK cells, MSCs, IPSCs, and even insect cells can offer unique benefits and improve gene therapy productions.
    • Maintain Comprehensive Documentation: Ensure rigorous tracking and documentation of all processes. From certificates of analysis to raw image data, having meticulous records will safeguard your development process and aid compliance with regulatory standards.

    Tune in to the full episode for more insights on overcoming challenges in cell line development and tips for setting up successful bioprocessing workflows!

    Connect with Andrea Gough

    LinkedIn: www.linkedin.com/in/andrea-gough-72915282

    Advanced Instruments: www.aicompanies.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 Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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    15 mins
  • 117: Critical Bottlenecks and Breakthroughs in Cell Line Development with Andrea Gough - Part 1
    Jan 7 2025

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    Cell line development (CLD) is a cornerstone of biologics production. This intricate process involves establishing a cell line capable of consistently producing a desired product, such as a therapeutic protein. While advancing science has refined numerous aspects of CLD, bottlenecks still exist, perpetuating challenges for scientists and industry professionals.

    In this episode of the Smart Biotech Scientist Podcast, Andrea Gough, Senior Director for Advanced Instruments’ Solentim Portfolio, shared her extensive insights into the critical bottlenecks and innovative breakthroughs in cell line development.

    Here are three key takeaways from this episode:

    • Understanding the DNA Integration Complexity: Andrea discusses the pros and cons of random integration, highlighting how it can become a bottleneck. She emphasizes the importance of choosing the right methodology from the very beginning to avoid the "needle in a haystack" scenario when searching for a good clone.
    • Modern Tools for Ensuring Clonality: Technologies like imaging devices and single-cell dispensers have revolutionized the process. Learn about the shift from traditional limiting dilution methods to more sophisticated and efficient tools that provide better evidence for regulatory approval.
    • Innovative Approaches to Accelerate Development: Discover how semi-targeted integration methods like transposon technology can significantly shorten timelines and improve clone stability. Andrea also explores the use of bulk pools to generate initial products quickly for pre-clinical and initial clinical studies.

    Developing cell lines is a complex process, but with advanced tools and innovative approaches, challenges can become opportunities. As biotechnology progresses, the ability to stay informed and flexible will remain essential for success.

    Catch the full episode to gain deeper insights and practical advice for advancing your cell line development projects!

    Join us for the next episode featuring Andrea Gough, as we explore how AI and machine learning are being integrated into the early stages of clone selection. This groundbreaking approach is transforming key areas of biotechnology, including cell line development (CLD).

    Connect with Andrea Gough:

    LinkedIn: www.linkedin.com/in/andrea-gough-72915282

    Advanced Instruments: www.aicompanies.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 Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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    24 mins
  • 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti - Part 2
    Dec 19 2024

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    The intersection of artificial intelligence and biology presents immense opportunities for transforming bioprocess development. As the biotech industry continues to evolve, data-driven innovations are critical to optimizing biologics manufacturing. High-quality datasets stand at the forefront of this transformation, empowering researchers to make informed predictions and advance therapeutic discoveries. As AI tools become more commoditized, the focus shifts toward generating robust and extensive datasets to maximize the potential of machine learning in biological applications.

    Miniaturization has emerged as a vital enabler in this data-driven approach. Miniaturized systems allow researchers to conduct thousands of tests in an area no larger than the palm of your hand. This drastic reduction in material and resource requirements makes high-throughput screening feasible, economical, and scalable.

    Traditional liquid handling robots can manage thousands of tests per day, but each test requires considerable amounts of material, usually leading to high costs. Conventional systems can cost anywhere from $10 to $100 to get a single genotype sequence from discovery to sequencing. Miniaturization can bring these costs down to mere pennies per data point, making it possible to scale the dataset size exponentially.

    Key takeaways from our discussion:

    • The future of AI in biology relies heavily on large, well-annotated datasets. Without them, the full potential of AI remains untapped. High-quality data enables more accurate predictions of protein structures and functions.
    • Success in bioprocess development often involves collaboration with partners across the value chain. By working together, companies can leverage their unique strengths and expertise to overcome barriers and innovate more efficiently.
    • Advancements in miniaturization technology allow for high throughput screening at reduced costs. This shift makes it viable to generate large datasets, speeding up the pace of discovery and making AI-driven predictions more accessible.

    This episode is essential for anyone eager to explore the transformative fusion of AI and biotechnology. Jeremy Agresti highlights the future of bioprocessing at the intersection of high-throughput screening, miniaturization, and AI, revealing how these innovations are solving complex challenges, driving breakthroughs, and shaping the future of science and medicine.

    Connect with Jeremy Agresti:

    LinkedIn: www.linkedin.com/in/jeremy-agresti-88546850/

    Triplebar: www.triplebar.com

    Next Steps:

    Overwhelmed by complex bioprocess development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.com

    Are soaring manufacturing costs keeping your lifesaving therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessment

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    17 mins

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