By Andrew Anderson, VP of Innovation and Informatics Strategy
For scientists involved in pharmaceutical development, high throughput experimentation (HTE) is commonplace for activities such as reaction optimization, process development, catalyst screening, and reaction scale-up. While there are many observed benefits of implementing HTE workflows in laboratories, it also dramatically affects corporate informatics infrastructures and there are significant impediments to its utilization. In order to optimize laboratory efficiency and support the lab of the future, the industry requires a technological solution that can help streamline workflows and demonstrate data integrity among rising burdens imposed by commercial and market demands for innovation and productivity.
While investing in multiple technologies including powder and liquid dispensing equipment, and lab automation for chemical synthesis reaction sampling and high throughput analysis has served as a short term fix in addressing some of the historical challenges, it has also resulted in a multitude of systems to manage the workflow. There is a lack of cradle-to-cradle integration between the various systems that companies depend on for high throughput experimentation. This has created a significant obstacle to the productivity objections of R&D organizations.
For example, when executing experiments, process chemists must implement a variety of critical process parameters to ensure their generated material meets the quality specifications imposed by QbD principles. To meet these requirements, chemists conduct a variety of orthogonal test types from the onset of an experiment. The goal is achieving the expected level of understanding of the cause and effect relationship between the design, process and products. Analysis of products is the final step that allows chemists to decide how best to move forward. When conducting analytical experiments, however, the resulting data creates a double edge sword. While each experiment helps manage the traceability of the product to the original sample and enables them to comply with QbD principles, copious amounts of data are also generated which must be transposed into decision support interfaces. As variables within each data set are often housed in separate applications, the industry currently relies on manual data entry and transcription processes to assemble and interpret the information into one system, to ultimately, support the formal documentation that illustrates QbD compliance and to make decisions regarding the progress of the project.
As you can imagine (and have likely experienced), this data entry process is extremely time consuming. In fact, it can often represent 75 percent or more of the total time scientists spend on product development. Consequently, with organizations across the industry suffering from inefficient data management processes imposed by QbD and high throughput experimentation, we would posit that now is the time to consider innovation of the supporting informatics infrastructures within the industry. Here at ACD/Labs, we’ve remained committed to connecting with our customers and aligning our technology to meet the evolving needs of chemical R&D to accelerate decision making and maximize productivity. Now in our 25th year, we recently launched Katalyst D2D to solve the industry’s greatest pain points in HT experimentation.
By offering a single interface for high throughput experimentation and parallel synthesis—from experimental design to final decisions—Katalyst supports the lab of the future by digitizing painstaking laboratory tasks, optimizing efficiency, and expediting product development. Katalyst is designed to eliminate tedious tasks scientists currently undertake to fill in gaps from the lack of end-to-end workflow support and to help R&D companies ensure data integrity among rising QbD requirements. Following experimentation, Katalyst’s decision support interface can help chemists quickly answer all process, material, and analysis related questions and also share and report results.
By equipping our customers with data on-demand capabilities, from design to decide, we expect that Katalyst D2D will better serve our customers’ evolving ways of work. As we celebrate our silver anniversary, the launch of Katalyst D2D demonstrates the company’s effort to help accelerate innovation in pharmaceutical R&D, now and in the future.
To learn more about how today’s Katalyst D2D technology can support tomorrow’s lab of the future, click here.