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In this insightful episode, Technical Development Leader at Flagship Pioneering Oliver Kraemer reveals why developing Advanced Therapy Medicinal Products (ATMPs) require a fundamental shift in thinking from traditional biologics development.

Drawing from his extensive experience across Boehringer Ingelheim, Sanofi, and BMS, Kraemer challenges conventional wisdom about process development timing and demonstrates why early integration of process considerations is crucial for ATMP success.

You will learn:

• Rethink Development Timing: Learn why incorporating process development earlier in ATMP programs dramatically reduces failure rates and prevents costly repetition
• Master Complexity: Understand the unique challenges of cell therapy development, including biological fitness and the critical interplay between cell lines, media, and processes
• Navigate Cost Implications: Discover strategies for managing the unexpectedly high development costs of ATMPs and making informed early decisions that impact commercial success

Ready to transform your approach to ATMP development? Join us for this must-listen episode as we demystify the path from bench to bedside in cell and gene therapy.

Connect with Oliver Kraemer:

LinkedIn: https://www.linkedin.com/in/oliver-kraemer

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 cell and gene therapies better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

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In this eye-opening episode, we explore the intricate landscape of Advanced Therapy Medicinal Products (ATMPs) with Oliver Kraemer, a technical development leader at Flagship Pioneering.

Drawing from his extensive experience at industry giants like BMS, Sanofi, and Boehringer Ingelheim, Oliver challenges conventional wisdom about automation in cell and gene therapy while illuminating the crucial differences between biologics and ATMPs.

Key Takeaways for Biotech Scientists:

• Discover why automation isn't the ultimate solution for advancing CGT development right now, and what this means for your process development strategy
• Learn how ATMP development requires a fundamental rethinking of the traditional research-to-development pipeline
• Understand the critical early-stage decisions in cell therapy development that can make or break your project timeline

Join us as Oliver shares invaluable insights from his journey from traditional biologics to cutting-edge cell therapies, including both iPSC-derived and donor-derived approaches. Whether you're a bioprocess developer, cell therapy researcher, or biotech professional, this episode offers practical wisdom for navigating the complex landscape of ATMP development.

Ready to transform your understanding of cell therapy development? Listen now to gain insights that could save you months or even years in your development timeline.

Connect with Oliver Kraemer:

LinkedIn: https://www.linkedin.com/in/oliver-kraemer

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 cell and gene therapies better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

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Want to peek behind the curtain of a leading Contract Development and Manufacturing Organization (CDMO)? In this inspiring episode, KBI Biopharma's Chief Scientific Officer Sigma Mostafa reveals the intricate world of bioprocess development and manufacturing.

Sigma shares game-changing insights into accelerating biologics development without compromising quality. She also unveils how KBI is leveraging AI and machine learning to revolutionize everything from protein sequence analysis to formulation development.

Key Takeaways:

• Learn how to master the art of seamless tech transfer
• Discover how to slash development timelines using innovative cell line technology and parallel processing
• Learn how AI and machine learning are transforming CDMO operations, from predicting developability challenges to automating lab processes

Ready to transform your bioprocess development journey? Tune in to hear Sigma's vision for the future of CDMOs and get actionable insights for your next project.

Connect with Sigma Mostafa:

Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817

KBI: https://www.kbibiopharma.com

Next Steps:

Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

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In this insightful episode, we're joined by Sigma Mostafa, Chief Scientific Officer at KBI Biopharma, who shares crucial insights on selecting the right CDMO partner for biotech development.

Sigma brings a unique blend of scientific rigor and practical experience to the discussion, having worked on both sides of the CDMO relationship.

Key Takeaways:

• Why harvest steps deserve more attention in bioprocess development
• The truth about one-stop-shop CDMOs versus specialized partners
• Critical factors in cell line and media selection that impact long-term success

Sigma emphasizes that successful CDMO partnerships hinge on transparent communication and cultural alignment, not just technical capabilities. She reveals that while one-stop shops seem convenient, partnering with specialized CDMOs who excel in specific areas often yields better results - as long as there's strong project coordination.

Whether you're a startup navigating your first CDMO relationship or an established biotech company looking to optimize your partnerships, this episode provides actionable insights for making informed decisions that will impact your project's success for years to come.

Listen now to transform your approach to CDMO selection and avoid costly pitfalls in your bioprocess development journey.

Connect with Sigma Mostafa:

Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817

KBI: https://www.kbibiopharma.com

Next Steps:

Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a text

Struggling to unravel the complexities of your bioprocess? Prepare for a paradigm shift as we dive into the world of Process Analytical Technology (PAT) with Katharina Dahlmann who is Application and PAT Expert at Hamilton.

This eye-opening episode dissects how PAT is redefining biologics manufacturing, balancing its immense potential against real-world implementation hurdles. Katharina navigates us through the intricate journey of scaling up, from micro-bioreactors to large-scale bioreactors, unveiling the hidden gems of early PAT adoption. Whether you're a startup scientist or a seasoned biotech veteran, this episode is packed with insights to elevate your bioprocessing game.

Tune in to uncover:

1. Strategies for overcoming PAT implementation challenges
2. Expert tips on scaling up your processes with confidence
3. A fresh perspective on cross-disciplinary collaboration in biotech

Don't let bioprocess complexity hold you back – listen now and harness the power of PAT to decode your processes like never before!

Connect with Katharina Dahlmann:

LinkedIn: https://www.linkedin.com/in/dr-katharina-dahlmann-616790180

Hamilton: https://www.hamiltoncompany.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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? Contact us at https://bruehlmann-consulting.com

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Unlock the hidden potential of your bioprocess! In this eye-opening episode, David Brühlmann sits down with Katharina Dahlmann, Application and PAT Expert at Hamilton, to explore the game-changing world of Process Analytical Technology (PAT).

Discover how PAT is revolutionizing biotech by providing unprecedented insights into cell behavior and process dynamics. Katharina challenges conventional wisdom, revealing that what we think we know about our processes may just be the tip of the iceberg. Learn how combining multiple PAT signals can extract meaningful knowledge, leading to more reproducible and efficient processes.

You will gain valuable insights on:

1. Leveraging PAT to optimize feeding strategies and reduce process time
2. Balancing inline and offline measurements for comprehensive process understanding
3. The future of PAT, including self-evaluating sensors and data modeling

Ready to take your bioprocessing game to the next level? Tune in now and transform your approach to bioprocess monitoring and control!

Connect with Katharina Dahlmann:

LinkedIn: https://www.linkedin.com/in/dr-katharina-dahlmann-616790180

Hamilton: https://www.hamiltoncompany.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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? Contact us at https://bruehlmann-consulting.com

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Imagine predicting your bioprocess outcomes as easily as checking the weather forecast. Sound impossible? Not anymore. In this insightful episode, we dive deep into the world of digital twins and process models with Fabian Feidl, co-founder and CTO of DataHow.

Discover how these cutting-edge tools are reshaping the biotech landscape, from simplifying complex processes to enabling personalized medicine. Fabian shares invaluable insights on implementing data-driven approaches, even for smaller companies with limited resources.

Key takeaways:

1. Learn how to start small and build powerful process models that drive real results
2. Discover the game-changing potential of combining AI with bioprocess expertise
3. Explore the future of personalized medicine through advanced data analytics

Ready to revolutionize your biotech workflow? Tune in now and unlock the secrets to smarter, more efficient bioprocessing!

Connect with Fabian Feidl:

LinkedIn: https://www.linkedin.com/in/fabian-feidl-a52b36b3

DataHow: https://datahow.ch

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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? Contact us at https://bruehlmann-consulting.com

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Are you ready to decode the future of bioprocessing? In this eye-opening episode, we dive deep into the world of digital bioprocess development with Fabian Feidl, co-founder and CTO of DataHow.

Discover how cutting-edge process models are transforming the biotech industry, bridging the gap between raw data and actionable insights.

Key takeaways:

1. Learn how process models can streamline development, reduce costs, and accelerate time-to-market for groundbreaking therapies.
2. Explore the game-changing potential of personalized medicine through predictive modeling in CAR T-cell therapy.
3. Uncover strategies to overcome organizational and technological barriers in adopting digital technologies for bioprocessing.

From optimizing experimental design to enabling data-driven decision-making, this episode is packed with invaluable insights for biotech scientists and leaders. Tune in now to unlock the future of bioprocessing and take your research to the next level!

Connect with Fabian Feidl:

LinkedIn: https://www.linkedin.com/in/fabian-feidl-a52b36b3

DataHow: https://datahow.ch

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation 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? Contact us at https://bruehlmann-consulting.com