With so many biopharmaceuticals obtaining breakthrough or fast-track designations, companies that use accelerated strategies to be first in human studies can be left with significant quality and manufacturing challenges that must be solved later on. Despite regulatory encouragement to create solid design spaces and define parameters according to quality by design (QbD), those may go by the wayside given the pressures of speed. The reward is the investigational new drug (IND) application itself — but if companies lock in subpar processes at that stage while trying to speed to IND, they could get stuck with them.
In this BioProcess International eBook, BPI’s editor in chief discusses the pros and cons of timeline acceleration in early development with Susan Dana Jones, senior vice president of product development at Harpoon Therapeutics. Speed at all stages can bring earlier achievement of development milestones (and ultimately return on investment sooner), but going too fast can leave gaps in process understanding and scalability that must be addressed.