Case Study: a major biopharmaceutical company achieves faster process development and regulatory submissions with ACD/Labs Luminata

How a Major Biopharmaceutical Company Improved Process Development and Regulatory Submission Efficiencies

a major biopharmaceutical company faced significant challenges in managing chemical process data and compiling regulatory submissions for a new API. Their teams relied on disparate electronic lab notebooks and inefficient Excel spreadsheets, which made tracking experiments, sharing analytical results, and locating specific data for decision-making a slow and cumbersome process. To overcome these obstacles, the company turned to ACD/Labs and implemented their CMC decision-support software, Luminata.

By using Luminata, ACD/Labs provided a centralized platform that aggregated data from multiple sources, simplifying batch comparison and the interrogation of impurity information. This solution drastically reduced the time spent searching for data and compiling regulatory documents, with one team member reporting a 33% increase in efficiency. The implementation by ACD/Labs not only accelerated the regulatory submission process but also fostered a stronger culture of data sharing and collaboration within the company.