Have you ever calculated the drawback on direct and opportunity costs when your freeze dryer is blocked by lyophilization cycles which take several days?
Take this opportunity and have your cycle parameters checked for 2,000 € only. Just send us your lyophilization process parameters, a printout of an actual lyo run and some samples.
Our experts will carefully analyze the data and identify any potential for process risk and process time reduction through:
- product quality risk assessment
- detection of technical weaknesses
- scale-up risk assessment
- potential product quality improvement
- potential cycle length reduction
Call on us to optimize the freeze drying cycle in our pilot lab and transfer a high speed cycle back to your GMP facility. New paths in program design empower us to quickly and efficiently generate a dry and elegant lyophilizate without compromising process reliability and product stability.
To safeguard transferability of the results we analyze the technical design and resulting capabilities of your production freeze dryer and adapt our advanced and highly flexible pilot freeze dryers to these conditions.
Moreover, we determine critical lyophilization parameters and explore the design space, for those parameters, in a well-defined robustness program according to ICH Q8. This approach significantly reduces the technology transfer risk from pilot scale to commercial scale production.