123: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein - Part 1

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

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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