Process Development
Discoverant Bridges Process Development and Manufacturing
Aegis' Discoverant supports pre-manufacturing processes by ensuring the fastest rate of progress through clinical trials, regulatory submissions, and scale-up to commercial operations.
The table below summarizes major tasks that must accomplished between the time a new therapeutic entity is identified as being of potential clinical and commercial interest, and the time it reaches stable commercial manufacturing operations. Pre-pilot development, pilot operations including scale-up, and commercial manufacturing operations are identified along with the process understanding and reporting tasks to which each area of operations primarily contributes.
While some tasks are unique to an area, all tasks rely on the comprehensive data access, analysis and reporting environment that Discoverant provides. This is essential for achieving the goals of "Design for Manufacturing"
- Access to multiple data sources
- Access to data from paper records
- Interactive access to all the process data (continuous, replicate and discrete) from all the relevant data sources
- Data access that can be used easily by multi-disciplinary teams without programming or SQL skills
