Month: December 2024

At ProJect Pharmaceutics CRO, we offer the expertise and flexibility to replicate your clinicaltrial conditions to evaluate the stability of your drug product during real application scenarios. Whether administered through bolus injection or infusion, we can replicate your specific procedures using the relevant materials and equipment (e.g. perfusor syringe pump, Closed System Drug-Transfer Device (CSTD), IV bag, IV line set, etc.). We also assist in identifying the most suitable filter units, tubing systems, and other necessary materials. Should any adsorption issues arise, we aid in identifying the most appropriate stabilizing agents at optimal concentration to align seamlessly with your DP formulation and manufacturing processes (i.e. lyophilization).
We conduct in-use stability studies for all classes of molecules for which we also offer formulation development and process development, i.e. biologics, ADCs, cytotoxic drugs, small molecules, and peptides. Our in-use safety laboratory is equipped with infusion stands for infusion via gravity and with perfusor pumps. We also operate a red-light laboratory for handling light-sensitive substances.

Changing and optimizing a process such as a freeze drying cycle during a technology transfer for finished dosage forms (FDF) can not only improve efficiency, reduce costs, enhance product quality but can often also profit from innovations and advanced technologies that the new site has to offer. Furthermore, there are new possibilities to adapt the lyophilization cycle to the new plant and to obtain a production slot more easily with a modern, efficient (cost and time-saving) lyophilization cycle that is optimally adapted to the product thanks to new technologies.
At ProJect Pharmaceutics CRO we are experts in lyophilization process development for injectable drug products and have installed advanced lyophilization technologies on site. By means of a very systematic (algorithm-based) approach we explore very quickly in up to five (!) lyophilization cycles max. the ideal freezing, sublimation and drying parameters. Challenging the final cycle program in a process robustness testing panel will evaluate the design space of the critical process parameters. Cycles optimized this way in terms of robustness and efficiency enable a very smooth tech transfer: with a validated design space and a robustly tested lyophilization cycle, the number of engineering batches needed during technology transfer can potentially be reduced.
If you would like to benefit fully from the switch to a new production site with an optimized, modern lyophilization cycle, please contact us

Determining the optimal secondary drying time in a lyophilization (freeze drying) cycle for drug products is critical for several reasons related to product quality, stability, and manufacturing efficiency:

• Controlling residual moisture content to enhance product stability and shelf life
• Minimizing process time and cost to improve manufacturing efficiency
• Preventing over-drying to avoid fragility of the lyophilized cake, or loss of potency, and to improve ease of reconstitution and overall appearance

Optimizing the secondary drying time during drug development is essential to balance quality, cost, and efficiency while ensuring compliance with regulatory standards and delivering a stable, effective drug product.
At ProJect Pharmaceutics CRO we are experts in lyophilization process development for injectable drug products. We have developed a smart approach to determine the required secondary drying time to achieve the target residual moisture content within a single (!) lyophilization cycle. By sampling sub-lots of vials closed at different time points during secondary drying, we can analyze up to ten (!) different, freely programmable timepoints during ongoing secondary drying.
If you would like to benefit from a secondary drying time that is optimally tailored to your product, please contact us.