BIO 2024: Continuous Manufacturing and Cost of Goods

Continuous manufacture of biopharmaceuticals is a hot topic in the industry. According to Himanshu Gadgil, CEO of Enzene Biosciences, continuous manufacturing has an impact on a company’s cost of goods. “For example, in a 1500-square-foot cleanroom, we can manufacture in a month currently around 10 kilograms of mAbs [monoclonal antibodies], and we are enhancing that platform where we should be able to manufacture on 40 kilograms of mAbs,” Gadgil says. Therefore, he explains, if a company wanted the same productivity at the moment, they would need a huge plant.

This is where continuous manufacturing is truly beneficial, Gadgil continues. “So, one of the biggest advantages of continuous manufacturing is cost of goods, because the operational cost is much lower than the conventional manufacturing, [because] the footprint is more compact, and at the same time, the productivity is also very high,” he says. “Because when you do perfusion, you get significantly higher cell densities almost five to 10 times higher cell densities than the conventional fed batch.”

When building a new continuous manufacturing facility, unit operations should be connected so that the process flows continuously, remarks Gadgil. “So, that whole process connecting is very, very challenging when you're starting out, but once you have the platform set up … the advantage of continuous manufacturing is that the footprint is very small, so you can easily scale out so once you have the platform, it is very easy to put more of the these and also from a geographical perspective,” he summarizes.

Click the video to watch the full interview. Enzene Biosciences will be showcasing its services at the BIO 2024 convention in San Diego, Cali from June 3–6.