Lyophilization Cycle Development & Optimization

VxP Pharma is extremely well equipped with state of the art equipment, lab-scale lyophilizers, and analytical capabilities necessary for supporting quick and stable development studies for your lyophilized product.  Our expertise in lyo process development and analytical services encompass multiple methods for lyophilization of biologics and small molecules.

We can effectively screen:

• Combinations of solvents (both aqueous and non-aqueous)
• Buffers
• Lyo/Cryo Protectants
• Bulking Agents

We also offers innovative approaches for the development of formulations and freeze-drying / lyophilization cycles by insuring a seamless transition from lab-scale to CMC manufacturing.  As your product advances toward commercialization and product volume demand increases, VxP Pharma can lyophilize your product as needed to maintain speed and stability into the clinical/commercial setting

• If you have an existing lyophilization process, we will work with you to transfer and to adapt your lyophilization cycles to our equipment.
• If the optimal lyophilization cycles have yet to be defined, the formulation group can develop a lyophilzation process specifically for your product using our development lyophilizers and in-house analytical expertise.

Our process team directs the scale-up of any compounding processes or lyo-cycles developed in our laboratories to ensure a seamless transition from lab-scale to clinical/pilot manufacturing.

Our formulation experts work first-hand with the production team to develop a smooth and efficient transition to plant-scale operation.  Experience has shown that the cycles developed in our laboratory-scale units scale-up very well to our clinical manufacturing lyophilizer, a large-scale cGMP production unit.