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19: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 1
20 min •
16 januari 2024
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/cdmoadvisor
Article: 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
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