1 Intelligent Scale Up
Process development
We transfer your process from the laboratory to industrial production.
- Technical adjustments, process development
- Process optimisation
- Test productions up to the complete
- Process validation.
Independent of suppliers and contract manufacturers (CMOs). Consulting and implementation.
MORE The scale-up of a new manufacturing method lays an important foundation for process development and the entire future industrial process.
A change in the scale of manufacture brings many challenges. We don't just rely on experience, but test and optimise every production on a small scale first. With the results, we simulate the implementation in the industrial environment, so we find optimal conditions even before the first test production.
You gain valuable time and are on the market faster!
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More power together Fast scale up with our proven procedures. Independent advice and implementation.
Design of experiments
Careful experimental design in the laboratory for the Scale up, prepares the basis for a fast implementation and a clean implementation of the regulatory requirements.
Process validation and production
We verify the successful implementation of the scale-up through the necessary process validations, including detailed documentation.
Unleash potential
Contact our experts to discuss your specific issue.
Take your processes to a new level - contact us! We will help you to success!
Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm - PMC (nih.gov)