WESTERN EUROPEANS GETTING OUT OF PROTEIN A FIRST
In our 7th Annual Report, one of the problems we continue to explore is how respondents are planning to move away from Protein A, and if so, at what
stages of manufacturing. This year, it turns out that globally, over 53% are considering alternatives to Protein A to reduce
costs in new production projects. However, only 8% will actually be moving away from Protein A for existing production projects
over the next 12 months (Figure 1).
Figure 1. Switching from Protein A usage: US versus Western Europe
Interestingly, though, a much higher proportion of Western European respondents indicated that they are considering alternatives
to Protein A. Nearly 77% of Western European biomanufacturers are considering Protein A alternatives to reduce costs. So it
appears that Western European facilities may be more ready to switch when the price of alternatives to Protein A are low enough
to make switching feasible.
To summarize, chromatography purification steps are having a significant impact on overall capacity today, (with 19% of biomanufacturing
facilities considering this step to be a 'significant' or 'severe' bottleneck). Protein A is right there in the middle. But
even as options develop and alternatives are approved, because Protein A works, it will likely still be the workhorse in the
downstream process for the foreseeable future. In fact, over the next 24 months, 15% of biomanufacturers simply are planning
on outsourcing their downstream process operations. But that will be the topic of a future column.
The April column incorrectly indicated that ADSEPT (ADvanced SEParation Technology) was made by Nysa Membrane Technologies.
The company's current name is Natrix Separations Inc.
Eric Langer is president and managing partner at BioPlan Associates, Inc., Rockville, MD. He is also a member of BioPharm International's editorial advisory board 301.921.5979, firstname.lastname@example.org