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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 success
• Master early-stage assessment: Understand the critical parameters that can make or break successful scale-up, from cell line selection to protein folding
• Future-proof your development: Gain insights into how AI is transforming protein manufacturability assessment and what this means for process development

Whether 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/cnse

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 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

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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-45b546182

Eppendorf Group: https://www.eppendorf.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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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 Wieninger

LinkedIn: https://www.linkedin.com/in/dr-simon-wieninger-45b546182

Eppendorf Group: https://www.eppendorf.com

Enjoyed 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 DataHow
• Episode 05: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov, the co-founder and COO of DataHow

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