OptiALTO™ Better Biologics Manufacturing

The best time depends on your molecule and priorities. Pre-clinical and early adoption of the OptiALTO™ platform can help address low yields or high clinical demand, especially for difficult‑to‑express molecules. Other entry points typically lie before Phase 3 optimization and during commercial scale‑up, or after commercialization for a second-generation process, when cost of goods (CoGs), supply reliability, and long‑term manufacturing efficiency become more critical. In many cases, the optimal approach is to design processes early with future intensification in mind, allowing flexibility to switch when the business impact is greatest.

The OptiALTO™ platform increases yield by enabling higher cell densities and sustaining productivity over a longer and more controlled seed phase. By combining high inoculation density with real‑time process control, the production bioreactor generates more yield per batch, often with a significant titer uplift, without changing the underlying cell biology. This allows manufacturers to increase productivity of their assets with the same facility footprint.

The OptiALTO™ platform is designed to maintain comparable product quality to traditional fed‑batch processes across key attributes such as glycosylation, charge variants, and purity. Because productivity gains are driven by increased cell mass rather than altered cell behavior, product quality profiles are typically consistent. When implemented with appropriate regulatory strategies, switching to an intensified process can be achieved without introducing unnecessary regulatory risk.

Cost-of-good reduction is primarily driven from producing more product with fewer batches and more efficient use of manufacturing assets. The effective reduction depends on the molecule, scale, and starting process, but higher titers and shorter or more efficient production cycles can contribute to a significant reduction in CoGs, particularly at larger and commercial scales.

At higher cell densities used in the OptiALTO™ platform, process analytical technology (PAT) such as Raman spectroscopy enables real‑time monitoring of nutrients and metabolic activity. While optional for OptiALTO™, PAT allows feeding strategies to dynamically adjust to the actual real-time needs of the culture, rather than standard protocols. PAT can also enable more stable, consistent process transfers that support scale-up, reduce variability, and help maximize the productivity benefits of process intensification.