5. Process intensification
While Bioprocessing 4.0 promises to bring the industry closer to an optimized bioprocess, achieving the ultimate goal of maximum efficiency requires companies to not only address the process, but also the materials and equipment used to enact it. Today, biopharmaceutical companies are taking a hard look at all elements that go into their bioprocess and seeking ways to set themselves up for maximally efficient production, said Gupta and Boulais. "This means finding ways to boost productivity while lowering costs – for example, by using fewer input materials, shortening timelines, and simplifying workflows in a smaller space. This approach is called process intensification."
One factor that underlies the growing need for process intensification is the specialization of biopharmaceutical products. This trend towards specialization will lead to a greater demand for low-volume batches and will introduce new variables to the manufacturing process, they remarked.
According to one analysis of commercial R&D pipelines, more than 80% of drug candidates between now and 2025 will meet demand with production of less than 500kg per year. To accommodate this trend, biopharmaceutical companies must simultaneously manage their high-throughput therapies and other, smaller-volume modalities within the same facility. To manage these workflows efficiently, companies must embrace process intensification, said the experts.
Process intensification has many layers, and it requires a multipronged approach to achieve its goals, commented Gupta and Boulais.
"In fact, several of the solutions we addressed so far fit a broader process intensification strategy. For instance, process intensification creates flexibility, which provides long-term benefits by enabling companies to more easily and quickly adapt to dynamic market needs. Single-use products reduce the use of harsh cleaning products and the time needed for cleanup, providing long term benefits over stainless steel only facilities. Advances in rocking motion and stirred tank bioreactors enhance flexibility and lower the cost of goods by giving manufacturers a choice of flexible upstream single-use seed train options. Together, all of these strategies lead to faster, more efficient production and less waste, the ultimate goal of process intensification."
The Future of Biologic Manufacturing
Even after the COVID-19 pandemic is over, the biopharma industry will continue racing to optimize their bioprocesses to save money and time. "We predict that process intensification will graduate from a nice-to-have to a need-to-have, as companies work to produce more with less. By investing in an intensified bioprocess, companies will be able to produce novel biologics quickly and efficiently, equipping them to handle threats to our health more effectively. We saw a preview of what optimization can look like amidst the race to develop a SARS-CoV-2, and in 2021 and beyond, this trend towards efficiency will continue."