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