BioPharm: Can you offer any best practices for embarking on a downstream manufacturing process overall?
Nelligan: Be open to change. The industry today is like the computer industry of the 1970s—we have seen a boom in technology that is
not slowing down. Our knowledge about how to best complete bioprocessing steps increases day to day, and that knowledge is
constantly being transferred into operations. Every day, we see new equipment arrive, better equipment, cheaper equipment—there
are all sorts of innovations happening.
In the industry today, there is a huge worldwide demand for therapeutic protein drugs that is showing double digit growth.
A lot of money is being invested in the industry in new products and processes, and at the same time, there is a drive to
reduce cost, to improve productivity, and to become more efficient. We have passed the stage where, perhaps five or six years
ago, it was important to make drugs at any price because they were so important. Now the goal is to make them as inexpensively
and efficiently as possible.
The cost of goods is becoming more and more important, especially when trying to break into new markets. Customers are demanding
that the price of biopharmaceutical products is reduced and better technology and more automated processes are developed to
enable this. These are the pressures we face in the biopharmaceutical industry. The objective is to make more powerful, more
affordable drug products going forward.
1. "Upstream Processing: A Primer," BioPharm Intl. 25 (9) 62–64 (2012).