MSAT & Processes
Automated data flows and GMP-compliant processes for your development.
Your task is to figure out how a substance can be produced not just by the milliliter, but at scale.
Of course, GMP is always on your mind—but you certainly don’t have time to dive into every detail of the regulations that will become relevant later. Especially when it comes to system integration and preparing for technology transfer, digitalization should ensure there are no unpleasant surprises down the line.
Challenges
Gap between R&D and manufacturing
Lack of process transparency
High effort in scale-up and tech transfer
Limited use of data for process optimization
Our Approach
Process Data Integration: Linking data across R&D, MSAT, and production.
Digital Tech Transfer Enablement: Supporting scale-up and transfer processes digitally.
Advanced Process Analytics: Using data to optimize and stabilize processes.
End-to-End Data Visibility: Providing transparency across the full process lifecycle.
Business Impact
Faster and more reliable tech transfer
Reduced scale-up risks
Improved process stability
Increased efficiency in development
Better data-driven decisions
Process Development and Analytical Method Development
We offer the following services during this phase:
Device and Data Source Integration
The electronic lab notebook (ELN) is where your work is documented. No one wants to manually copy measurements from a device display or use copy & paste from another software tool. We help you ensure that this information is transferred automatically and accurately to where it’s needed.
Data Provision & Technology Transfer
The results of your work deserve to be used by others. Building the right data storage solutions and providing secure, user-friendly interfaces for access are among our core competencies—whether for fully open publication or for transitioning into the GMP environment.
Consulting on the Modernization of ELN Templates
To ensure a smooth transfer of results from process development to production, the structure of experiment documentation, production recipes, and parameter sets should be as similar as possible. With our experience in these processes, we can help you structure your ELN in a way that makes handing over results seamless.
Our References
Questions about Process & Analytical Method Development?
You’ll find them here!
Mario Radic
IT Consultant, Project Manager