Wednesday, September 23, 2020

Scale Up vs. Scale Out

As the biotech industry continues to grow, and production volumes expand, biomanufacturers continue to look for new ways to reduce cost as they accommodate this demand.  One way is to continue to scale up through larger, 10,000 L+ stainless steel bioreactors that have the potential to reduce cost per gram through larger cultures.  An alternative is to scale out, using 2.000L and smaller single use bioreactors that can run in parallel, or in different geographical locations in order to reduce distribution costs to reach patients across the world.  

In practice, many biomanufacturers are looking at combinations of scale up and scale out that can meet various demand levels.  However, with CDMOs taking a larger share of the industry’s manufacturing volume, they need to sustain processes for far more drugs than firms that only manufacture  products developed internally.  In turn, they are looking at scale out designs that allow them to produce a greater range of products than traditional scale up systems.

Single use bioreactors reduce the risk of cross contamination from products sharing a facility, and that plus their flexibility makes them ideal for scaling out production.  Additionally, multiple lines create redundancy should something go wrong with any particular batch.  

The growth of scale out systems does not mean scale up will disappear.  Low titer products like antibodies are often sold in high doses and at high volumes, which still fits well with reusable, large bioreactors.  Similarly, scale out is seen by some as being linked to specific products, particularly autologous therapies like CAR-T.  Due to the sensitives of these therapeutics coming from and going back into the patient, scale out can preserve quality better than scale up in some cases.  However, for more traditional allogenic therapies, scale up can still offer not just lower cost, but provide greater consistency.

While sometimes presented as alternatives to each, it appears that both scale up and scale out will both have applications to serve for years to come.  The decision to use or another will ultimately come down to the type of biologic being produced, not an overarching philosophy about how to manufacture therapeutics.

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