Biosimilars Developer Automates Delivery Of External Manufacturing Partner Batch Data To Accelerate Workflows

A leading pharmaceutical company develops a variety of biosimilar and novel therapies for immune-mediated diseases. It has an extensive pipeline of drug candidates that target disease areas to provide substantial benefits over the existing standard of care.

The company relies on third party contract manufacturing organizations (CMOs) to produce clinical and commercial biosimilars and other pharmaceuticals at scale. In support of its manufacturing operations, the company’s external partners collect large volumes of batch data that must be approved and reconciled; however, it had relied on manual processes, differently formatted spreadsheets and PowerPoints, email, and network file folders to manage batch records. The company wanted to improve data visibility and sharing across their globally dispersed CMO network, automate process data analytics, and easily centralize and manage batch data, process specifications, and control limits.

They partnered with Skyland Analytics following a trial of the provider’s cloud-based Process Information Management System (PIMS™), which provided everything needed in one affordable package.