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Practical Strategies for Scaling

Up Production & Transitioning from

Pre-Clinical to Commercial Manufacturing

Presenters:

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Aaron Mendelaw
Director, Commercial Strategy,
KBI Biopharma
 
Aaron Mendelaw, Director, Commercial Strategy Aaron Mendelaw is Global Director of Commercial Strategy at KBI Biopharma, where he leads initiatives that align commercial strategy with manufacturing execution to drive scalable growth across the biopharmaceutical development and production lifecycle.
 
With a background spanning biomanufacturing, business operations, and strategic leadership, Aaron brings a practical, results-oriented approach to bridging technical and commercial priorities. He is recognized for translating complex manufacturing challenges into actionable strategies that enhance efficiency, scalability, and reliability in GMP environments. His expertise in Lean Manufacturing and Six Sigma supports process optimization, continuous improvement, and consistent delivery across fast-paced, regulated operations.
 
At KBI, Aaron focuses on ensuring that manufacturing capabilities and process strategies align with evolving client demands and industry expectations. In addition to his role at KBI, Aaron serves on the Advisory Board for the Strategic Artificial Intelligence (AI) Program at Furman University, contributing to the application of AI in operational performance and decision-making. Aaron holds a degree from Virginia Tech.

 

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Kevin Tolley
Director, Manufacturing Sciences,
KBI Biopharma
 
Kevin is the Director of the Manufacturing Sciences and Technology group at KBI Biopharma’s Boulder, Colorado site. He has over 25 years of experience in process engineering and manufacturing sciences with 10 years of experience at KBI Biopharma and previous roles at Thermo Fisher Scientific and Amgen.

 

 

 

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Doug Eggers
Senior Manager, Manufacturing,
KBI Biopharma
 
Doug Eggers is a Senior Manager of Manufacturing Sciences and Technology at KBI Biopharma, where he leads a team of talented Process Engineers to implement and manage clinical to commercial GMP manufacturing processes for a variety of clients. Doug has a background in both mammalian and microbial biologics manufacturing and over 15 years of industry experience, and has specialized expertise in bioprocessing equipment, technology transfer, quality systems, and regulatory compliance. With a collaborative approach and analytical mindset, Doug excels at solving intricate technical challenges and provides phase-appropriate solutions to advance life-changing biopharmaceutical manufacturing. Outside of his professional endeavors, he is an automotive enthusiast, tech hobbyist, active outdoorsman, and father of two. Doug holds a degree in Bioengineering from Binghamton University in New York.