Freeze Dry / Lyophilization

Synergy Bioscience has extensive expertise and state of the art equipment to develop lyophilized / Freeze Dry preparations with expanded capabilities that will meet your product’s therapeutic needs and regulatory requirements. From product characterization and cycle design to scale-up and clinical trial material preparation, we can safely and effectively exceed your expectations.

Whether you are experiencing lyophilization / freeze-dry cycle performance issues would like to shorten the cycle time, or even improve your product, Synergy has the capability and technical expertise to establish processing procedures that are safe, effective, and sufficiently robust. Process improvement, troubleshooting, and technical transfer are also services that we will gladly offer. Our facilities are well-equipped for conducting a diverse range of experiments including formulation development, cycle design, process improvement, as well as evaluating the finished product. Our comprehensive development reports will also support your regulatory filings for product commercialization.

At Synergy, we understand that product characterization is critical to the development of a robust lyophilized product. In order to limit changes during the lifespan of the product, our development approach ensures that the final process is practical and efficient.

We have the technical expertise to successfully develop formulations for diverse products, such as biologics, polypeptides, therapeutic proteins, vaccines, highly potent compounds, and antibody drug-conjugates.

Synergy develops all lyophilization / Freeze Dry studies with a manufacturing mindset in focus from the start and we are uniquely adept at facilitating the technical transfer process.

Combining product development and clinical manufacturing at a capable source, like Synergy, whose focus is on the unique needs of a lyophilized product can reduce costs, improve efficiency, and mitigate risks along the way. With flexibility, extensive capabilities, and a focus on your product needs, we can accelerate moving your product from development through producing Clinical Trial Material much quicker than others.

Whether you are developing a completely new product, making the switch from a vial to a cartridge/syringe, or ready to process Clinical Trial Material, you can rely on our experience in this fast growing field.

To discuss how Synergy Bioscience can help you, please contact us