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Virtual Pharma: Lyophilization Cycle Development & Optimization

May 25th 2015 at 11:45 PM

VxP Pharma Services has recently expanded their lyophilization services to now provide cycle design, process development, and optimization studies to the list of our capabilities. These new services will help in stabilizing materials for lyophilization early in development, as well as helping companies with excipient selection for an optimally lyophilized and consistent product.

A common goal in the development of a lyophilized product is to produce a pharmaceutically elegant and physico-chemically stable product that can be easily reconstituted and administered to the patient.  VxP Pharma can assist you in reaching that goal by providing the laboratory equipment, lab-scale and full-scale production lyophilizers, and analytical capabilities necessary for supporting quick and stable development studies.  The scientists’ expertise in process development and analytical services encompass multiple methods for lyophilization of biologics and small molecules.

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Lyophilization Cycle Development & Optimization

Development of optimized lyophilization cycle and use of stabilizing excipients are adopted to overcome challenges of the process early in the development timeline. We can effectively screen for combinations of solvents (both aqueous and non-aqueous), buffer, lyo/cryo protectants, and bulking agents.The team of scientists can offer innovative approaches for the development of formulations and freeze-drying 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 stability and speed into the clinical/commercial/large-scale setting.

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

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The development team manages the scale-up of any compounding processes or lyophilization cycles developed in our laboratories to ensure a seamless transition from lab-scale to manufacturing.The 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, which is a 48 square-foot cGMP production unit.

 

 

 

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