In the early stages of biologics development the bioproduction group faces many challenges, a major one being that the therapeutic molecule is typically in very high demand from many internal groups. One thing that these groups have in common, they all say “I want it now” (ok maybe they don’t exactly say that, but they urgently need the therapeutic molecule). This is especially common when projects are moving quickly through the development process, or if there is a sudden priority placed on a specific project.

Ideally the bioproduction group would be working with a cell line that delivers very high product titers and easily produces enough material for all needs, but not everybody gets huge g/L from every product. It becomes necessary to ration and allocate the therapeutic molecule very judiciously, and inevitably somebody will be unhappy with the quantity or delivery date that they receive. If it were possible to reengineer the cell line to be higher producing, that’d be great, but usually this is out of the question. There are a lot of tools available to develop high producing cell lines such as proprietary cell lines, high throughput techniques, metabolic and genomic methods, etc., but those are typically used at early stages of cell line development.

For a more immediate fix, there are relatively few options. Performing additional bioproduction runs is possible, but there are capital and labor constraints to consider. The groups that need the therapeutic molecule could scale down there assays and experiments (number performed through DOE, or physically scale them down to use less material). Upstream process development usually is the most feasible option, a critical component of that is media development.  Many companies are developing cell culture supplements that are great tools and can be used in upstream process development for a “quick fix”.