Driving Advancements in Biopharmaceutical Manufacturing

Productivity – What is it and how do we improve it?

Jan 04 2021

What exactly is productivity? At PAK BioSolutions, we define productivity for a biopharmaceutical process, whether batch or continuous, as the grams of drug product produced, per unit time, at a given cost. Further complicating the issue, cost is another difficult variable to define. We have to consider the capital costs of the equipment used to produce a drug, the costs of the raw materials such as chromatography resins and cell culture media, and the labor costs to perform each manufacturing step. But if we look at each component individually, we can start to get a better sense of what a productivity increase really looks like. Importantly, there is more than one way to increase productivity of the biopharmaceutical manufacturing process.

Traditional batch manufacturing processes are performed one step at a time. Conversely, if we perform each step at the same time, as we do in a continuous process, with a delay of just a fraction of the batch run time between the start of the first step and the last, it’s easy to see that manufacturing time is reduced. For example, if there are four purification steps that used to be performed sequentially but are now performed simultaneously, keeping cost and batch size the same, the process concludes four times faster and productivity increases four-fold. Instead of a four-day process to run four steps, we can complete all steps in one single day.

A reduction in time is great if a facility has a full schedule, but increased output may be of greater importance if demand for a product is high. In this scenario, rather than using a continuous process to perform a run in a quarter of the time of a traditional batch process, we run for the same duration but produce four times more drug product. This simply demands using the same process from scenario one continuously for four days instead of one.

The third way manufacturers can use continuous processes to increase productivity is to maintain the same run rate and batch volumes of a traditional batch process, to reduce production costs. This occurs because of reductions in resin volumes and equipment capital costs for new facility builds. Details will follow in a separate post.

Manufacturers designing a continuous process have three options to choose from to increase their productivity. The best option depends on their priorities: speed, volume, cost, or a hybrid of the three. Continuous manufacturing will make the creation of life-saving pharmaceuticals more customizable – and more efficient – than ever before.

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