Vendor Sheet
Hidden Challenges in Biopharma Development
The Hidden Challenges in Biopharma Development report highlights how fragmented data management is slowing innovation and increasing the cost of drug development. Survey findings show that 50% of process development teams rely on legacy electronic lab notebooks, while the other 50% use paper records, Excel spreadsheets, and standalone software that are difficult to search, integrate, or analyze effectively. These disconnected systems create major bottlenecks throughout the development lifecycle. The largest challenge identified was compiling data for regulatory submissions, followed by process definition and understanding, and process scale-up. Poor data accessibility and fragmented workflows contribute to rework, quality assurance issues, delays in technology transfer, and regulatory fili
