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03: How to Master Biotech Scale-up Without Guesswork w/ Leonardo Sibilio - Part 1

03: How to Master Biotech Scale-up Without Guesswork w/ Leonardo Sibilio - Part 1

FromSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists


03: How to Master Biotech Scale-up Without Guesswork w/ Leonardo Sibilio - Part 1

FromSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

ratings:
Length:
17 minutes
Released:
Nov 7, 2023
Format:
Podcast episode

Description

In this captivating episode, we delve into the world of biotech scale-up with the seasoned expert, Leonardo Sibilio, CSO at BetaPro Consulting and CEO of the Biotech Academy in Rome.Discover how mastering the art of biotech scale-up can transform your journey from doubt to dominance.Key Takeaways:1. Early Planning is Paramount: Leonardo emphasizes the importance of initiating the scale-up process as early as possible. Waiting until later phases can lead to challenges and hinder progress. Early planning, including characterizing the cell line and ensuring stability, is key to a seamless transition from R&D to large-scale production.2. Mindset Shift is Crucial: Successful scale-up requires a shift in mindset, especially for startups originating from academia. Transitioning from research to regulated environments demands precision, rigorous documentation, and an unwavering focus on producing life-changing medicines.3. Embrace Learning and Structured Processes: Leonardo encourages the use of structured methodologies and tools like R or Python for better data analysis and visualization. Structured documentation and reporting are critical for regulatory compliance and efficient tech transfer.Join us as we explore the challenges, pitfalls, and strategies of biotech scale-up, unlocking the secrets to mastering it without guesswork.Whether you're a seasoned professional or new to the field, this episode provides valuable insights for anyone interested in bioprocess scale-up and commercialization.Connect with Leonardo Sibilio:LinkedIn: www.linkedin.com/in/leonardo-sibilio-9bb26320
Released:
Nov 7, 2023
Format:
Podcast episode

Titles in the series (51)

The Go-to Podcast for Biotech Scientists Who Want to Master Bioprocess CMC Development and Manufacturing of Biologics.Do you want to simplify bioprocessing so that you can scale with confidence and reduce time to market?Are you sick of feeling overwhelmed by the complexity and guesswork of biologics drug development?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 without delay your groundbreaking therapy to clinics and market, and still enjoy every single step.Hey, I’m David Brühlmann, biotech entrepreneur and consultant, international technology transfer expert, and innovation coach. I’ve been there. And guess what, science may give you headaches, but biologics drug development should not.Want to learn how I and many industry experts did it?- In this podcast, you will learn:- How to develop bioprocesses with peace of mind- How to master biologics drug development- How to deliver your life-transforming therapy to clinics and market fast and efficiently- How to actually enjoy doing all thisI 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? Binge-listen mode: Go!Next Steps:Visit the Website: www.smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com