When a biologics company is preparing to launch a new product, its manufacturing capacity forecast is subject to a great deal of uncertainty. When firms end up with a supply shortfall, they may learn the hard way that securing additional capacity for biologics is expensive and time consuming. Meanwhile, overestimating demand can waste valuable resources and cut into the bottom line.
Solving this problem is more complicated than just managing volume uncertainty. Biologics developers must consider scale and volume—in that order.
Need: Clearer Picture of Demand
Solution: Focus on Scale
Focusing on scale before volume helps avoid the expense of validation batches and wasted supply.
Firms know their titer early in the process, and thus have a good idea of their biologic API’s cost in dollars per gram. Presuming this cost fits the projected market price, companies can use the figure to determine their optimum production scale.
Large innovators can usually produce $100–150/gram with dedicated capacity. For smaller production volumes with a cost of approximately $350/gram, the best solution is outsourced production of two or three 2,000-L bioreactors.
When costs fall in between, firms might consider self-building capacity or a combination of insource–outsource manufacturing.
Need: Safer Supply Forecasting
Solution: Flexible Scale Manufacturing
Another way clients can mitigate the risks of forecasting capacity is to partner with a provider of flexible manufacturing solutions that reduce the possibility of clinical failures or clinical/commercial production inability. One solution is multiplexing, which involves a CDMO adding several 2,000L single-use bioreactors to a process to drive a larger downstream volume. This flexible and scalable manufacturing option builds customization into what is normally an unpredictable and rigid situation.
The modular multiplexing approach saves clients time in another important way: revalidation time and effort are not needed during scale-up. If a CDMO anticipates during their evaluation process that a client may need additional production capacity in the future, they should build that capability into the initial process design, thereby eliminating the revalidation process.
In the end, multiplexing lets clients focus on robust process development without having to be fixated on anticipating their bioreactor size.
Need: Better Cost-of-Good Metrics
Solution: Flexible Cell-Culture Harvesting Options
As increasingly complex biologic molecules occupy a larger piece of the pipeline at biopharmaceutical companies both big and small, a CDMO’s ability to respond to customer demand is strongly tied to its cell-culture platform offerings and high-density solutions.
For instance, after evaluating a product’s stability, a CDMO may determine that perfusion is the best choice. At Patheon, we believe XDTM high-density perfusion cell culture helps increase yield at a lower production scale, which has a positive cost-of-goods impact for customers. In addition, perfusion processing can build a very consistent end-product because of the steady-state conditions inherent in this technique.
Learn more at www.patheon.com/en-us.