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.
Operational Needs
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.
Evaluation Process
Seeking a commercial software product to solve its complex batch data management challenges, the company researched multiple vendors and products. It decided to partner 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.
Why Skyland PIMS®?
The following were reported as top value propositions:
- Batch data management – Skyland PIMS enables the company to efficiently consolidate batch data records from its multiple CMOs into a single version of truth for validated, analysis-ready product and process information.
- Software licensing – Superior total cost of ownership provides immediate value while creating opportunities to drive long-term cost efficiencies and return on investment.
- Skyland team – The company reports that the expertise and high degree of knowledge demonstrated by Skyland’s technical team in quickly answering complex questions was influential in its decision to select Skyland PIMS.
