This specialty biopharmaceutical company has consistently taken on some of the most challenging tasks in medicine, developing innovative treatments for some of the most difficult to treat diseases. By combining the resources of a large pharmaceutical company with an entrepreneurial desire to explore, this company is one of the most productive R&D organizations in the industry.
Tech transfer in the pharmaceutical industry focuses on the advancing of new drug candidates from development to manufacturing, and a key step in this process is defining the formulation of a drug product. This is especially true with large molecule products: scientists must determine the optimal conditions and excipients to preserve the specialized chemistry of a large molecule. Despite increasing pressure to improve lab productivity, the pharmaceuticals development team struggled with tech transfer due to disconnected and unstructured data sources. This work was often done manually: scientists copied and pasted data from their various lab informatics sources, including legacy electronic lab notebooks, lab information management systems, and process intelligence systems into Excel spreadsheets to do analyses and share results with colleagues. While this process was error-prone and time-consuming, it also had to be repeated each time a scientist wanted to compare different products or parameters. This turned the pharmaceutical formulations development process into a serious bottleneck for tech transfer. To address this, the R&D staff sought to implement an IT solution which enabled their development and manufacturing teams to access their relevant data more easily, perform analyses “on demand,” and share data with their colleagues across the enterprise.
To overcome the underutilization of data due to disconnected processes the R&D leadership worked to connect BIOVIA Workbook, BIOVIA Discoverant and a third party chromatographic data system. By creating a bridge between these systems, they are now able to automate many key tasks in the tech transfer process.