Investing in Process Development

by Geoffrey Hodge
Volume 3, Issue 2 (March/April 2004)

Process development is an investment. As with a personal retirement plan, the importance of making the investment is not in question, yet strategies for when, how much, and where to invest in process development vary significantly from company to company. For a personal retirement plan, the answers to these questions are straightforward: invest as early as you can and as much as you can, and take less risk the closer you get to retirement. This would also be sound advice for investing in process development (substituting ā€œBLA filingā€ for ā€œretirementā€) were it not for two complicating factors. First, the majority of biotherapeutics that enter the clinic fail to make it to the market. This makes a large, early investment in process development less attractive. Second, there is extreme pressure to get into the clinic, and subsequently onto the market, as quickly as possible, minimizing the time available for process development…

Hodge G. Investing in Process Development.Ā BioProcess J, 2004; 3(2): 31-35.