Global Biotech Centralizes The Management Of Batch Data, Process Specifications, And Control Limits

A biotechnology company with a validated, innovative scientific platform manufactures a variety of generic drugs and focuses on developing novel therapeutics to treat rare, immune-mediated diseases. It has an extensive pipeline of drug candidates that target disease areas with significant unmet need in which the current standard of care falls short.

Operational Needs
The Company relies on third-party contract manufacturing organizations (CMOs) to produce batches of a number of its generic commercial pharmaceuticals and leading drug candidates in late-stage clinical trials. In support of its manufacturing operations, the Company’s CMOs collect large volumes of batch data that must be approved and reconciled; however, it had relied on manual processes, spreadsheets, and network file folders to manage batch records. The Company wanted to centralize and streamline data management for batches, process specifications, and control limits.

Evaluation Process
Seeking a commercial software product to solve its complex batch data management challenges, the Company researched multiple vendors and products. They decided to partner with Skyland Analytics following a trial of the cloud software provider’s Process Information Management System (PIMS™), which provided everything it needed in one affordable package.