Thursday, September 24, 2020

Can Process Intensification Reduce Biomanufacturing Costs?

Rentschler Biopharma, a global CDMO, claims to have sped up its upstream cell culture process by 35% by seeding a bioreactor with a greater number of cells.  The objective was to reduce the time needed for cells to grow in a typical fed batch process.   By increasing the seeding, more biomass was created, which in turn accelerated the proliferation of cells within the culture.

With the expectation of reduced time to peak cell production, monitoring the culture took a higher priority.  To support this, the company invested in spectroscopy devices that could automatically probe the bioreactor without having to take human measurements.  This also reduced the risk of contamination because there was no need to have a person pull out samples.

Not only does this process save time, it reduces the number of steps needed to get to the “N” bioreactor phase.  Only the N-1 bioreactor step is needed before putting the culture into production.  Therefore, this approach fits into the category of “N-1 Perfusion” many in the industry are investigating as a means to better cost efficiency.

The article provided little detail on how time savings translated into cost savings, and while it mentioned the process was cGMP compliant, little data was offered to compare quality metrics.  Another major item missing from the story was the cost of raw materials.  There’s clearly a financial trade-off here, and it would have been useful to quantify that.   Moreover, in the crowded CDMO market, Rentschler, which entered the US in 2019 when it acquired a manufacturing facility near Boston, has been trying to distinguish itself as an innovator in process intensification for both upstream and downstream manufacturing.  This requires it to make investments elsewhere, and the cost trade off might not pay off.

Rentschler believes that moderate intensification that reduces the time in the bioreactor from 16 days to 12 days minimizes costs the most.  Reducing time further drove up material costs to the point that they exceeded the financial benefits of a shorter scale up time.

In addition to materials savings, there are other approaches to intensification other CDMOs are implementing as they prepare to increase production to accommodate biosimilars.  Samsung Biologics, Repligen, and others have developed N-1 perfusion schemes aimed at achieving similar productivity gains.  

While specific approaches may be proprietary, potential cost savings could make N-1 perfusion more standardized across CDMOs as they aim to reduce costs.  However, it appears that better optimization of raw materials will be essential to making process intensification as cost efficient as it is time efficient. 

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