The establishment of a mAb platform that is capable of delivering drug substance for less than $100/g has sparked a debate, which this keynote will not resolve, about the value of new technologies in purification of biopharmaceuticals.  There is, I believe, still room for significant inventions downstream, especially if downstream scientists look at the broader picture. In view of this broader picture, I concede that, except in a minority of cases, commercial COGs for mAbs is not a significant factor in the established industry. One important exception is the work that supports the hopes of the Bill and Melinda Gates Foundation, where significant innovation is required to achieve less than $10/g for perhaps as many as 10 million to 100 million patients.  There are, however, broad areas where innovation is required downstream.  Over capacity is often cited one impediment to innovation--radically new inventions often require a green field facility. Unfortunately, the overcapacity is in the wrong places. Innovation is needed to allow small new facilities to be built quickly with minimal resources at the 100kg scale. Including the necessary QA, can such a facility be build and running in 6 months and have the same COGS as a large 12kL six pack? This speed and cost is not currently possible, and innovation, especially in the area of assurance of quality, may make this possible.   Reducing the time from research to clinical trials is another area that requires downstream inventions for mAbs but especially for non-mAb modalities. Research groups can benefit from knowledge, tests, and devices conceived by process development scientists.   Innovation that allows faster research while at also providing information to process scientists can result in shorter timelines. Impacting the speed to the clinic will have a much bigger impact on the biopharmaceutical industry than a simple focus on COGs.   There are many areas that require innovation downstream. Oftentimes downstream scientists are too focused on local problems, such as how to replace the expensive Protein A column. This kind of problem is not, in my opinion, the right one to solve. Instead, understanding the world outside of downstream, finding strategic values and only then working out how inventions downstream can enable those strategies. It may then be that the cost of Protein A is a problem to be solved (I doubt it). If that is the right problem, the solution will come in the context of the larger strategy, and likely be solved in surprising ways.

Where is there a need for invention in biopharmaceutical purification?

247th National Meeting (2014)

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