Tired of burning money with day-long lyophilization cycles? Longing for a short, efficient, but robust lyo cycle? Maybe even tough enough to go for a modern, single-step overnight cycle?
Check out our “check your lyo cycle“ service offering:
You do not need to have a project running with us. You do not need to disclose your API nor any other details of your drug product. We simply need lyophilization process parameters, a print out of an actual cycle, and some samples of drug product (2-3 vials).
Our experts will carefully analyze the data and identify any potential risk and process optimization:
- Product quality risk assessment
- Detection of technical weaknesses
- Scale-up risk assessment
- Potential product quality improvement
- Potential cycle length reduction
Even if one-step overnight cycles are one of our specialties, we understand that this might be too explorative for most clients. However, we are known to deliver shorter cycles than market average. If you also want to find out whether you can save money during lyophilization and shorten your lyo cycle to attractive conditions for CMOs, contact us.
Check out our “check your lyo stopper” service offering:
Are you sure your stopper is dry enough to be safe enough for your lyophilized drug product’s stability? Have you ever experienced increase in residual moisture content in your lyophilized drug product and could not explain why? Do you know the moisture uptake capacities & water release characteristics of your lyo stopper?
An increased residual moisture content could be caused by incomplete drying of the stopper after sterilization. Some stoppers feature a higher moisture uptake potential, weaker stopper drying kinetics and lower water release characteristics than others. Some stoppers are simply subjected to an inefficient drying process at the CMO – without anyone noticing.
You do not need to have a project running with us. You do not need to disclose your API nor any other details of your drug product. We simply need the sterilization and drying process protocol for your stoppers as performed at your CMO, and some stoppers (~ 100 pcs). Our experts will conduct a comparative evaluation of your stoppers versus modern state-of-the-art stoppers and carefully evaluate stopper drying kinetics, moisture uptake potential & water release characteristic.
If you also want to find out whether you are already using a stopper that safeguards your lyo product, contact us.