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

• 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.

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

Support the show