Month: April 2024

Has your CMO (contract manufacturing organization) also started yet rejecting customers who show up with day-long lyophilization cycles? As securing production slots becomes increasingly challenging in today’s competitive contract manufacturing landscape, this is likely to affect more and more customers who come in with an old-fashioned, multi-step and super conservative freeze-drying cycle.

At ProJect Pharmaceutics, we are specialized in determining modern freeze-drying cycle parameters in just five (!) rounds based on a smart and firm in-house algorithm for process and formulation.

A short and modern lyophilization cycle

• reduces parameters, enhances robustness and simplifies validation
• improves accessibility to CMOs
• drives down manufacturing expenses

Although one-step overnight cycles are one of our specialties, we understand that this might be too explorative for most clients. However, we are known for delivering shorter cycles than the market average. On top, we support the implementation at the commercial plant in communication with the CMO towards a seamless technology transfer.
If you also would like to find out whether you can save money on freeze-drying and shorten your lyo cycle to attractive conditions, contact us.

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.

Check out our “check your lyo stopper“ 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 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 on 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.

Have you ever calculated direct and opportunity costs resulting from several day-long lyophilization cycles at your CMO?

Want to get easier a slot at your CMO with an optimized cycle?

Want to check your cycle for robustness prior transfer into GMP manufacturing?

Tired of burning money with day-long lyophilization cycles?

Longing for a slim, 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.