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19: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 1

19: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 1

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


19: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 1

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

ratings:
Length:
20 minutes
Released:
Jan 16, 2024
Format:
Podcast episode

Description

Are you ready to unlock the secrets of taking your molecule from the lab to clinical trials?Join us in an exclusive interview with Bernardo Estupiñán Gaisbauer, a seasoned expert and principal at Drug Biologics Consulting, as he reveals the crucial steps and strategies necessary for a successful journey in CMC development.Biotech scientists often underestimate the challenges of transitioning a molecule from the lab into large-scale production. Bernardo emphasizes the critical importance of addressing Developability and Manufacturability early on.Key Learnings:Consider Developability and Manufacturability: The success of your biotech asset hinges on developing a scalable process and ensuring cost-effective manufacturing. Assessing these aspects early guides strategic decision-making.Start Early: Bernardo stresses the need to consider crucial milestones from the moment you conceive a promising molecule. Avoid costly delays by initiating conversations with potential partners and service providers at the earliest stages.Find a Balance for Regulatory Aspects: While regulatory considerations are crucial, Bernardo advises against premature obsession. Prioritize good laboratory and manufacturing practices initially, saving detailed regulatory planning for later stages.Discover how to overcome challenges, optimize manufacturing, and navigate regulatory requirements. Don't miss out on this valuable opportunity to accelerate your biotech success!Connect with Bernardo Estupiñán Gaisbauer:Website: www.drugbiologics.com/cdmoadvisorArticle: In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist?: www.bioprocessonline.com/doc/in-search-of-the-unicorn-do-end-to-end-c-x-dmos-really-exist-0001
Released:
Jan 16, 2024
Format:
Podcast episode

Titles in the series (49)

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