Our biologics Process Development group can develop an entire process or optimize individual steps in an existing process to ensure the process is suitable for manufacturing in a cGMP environment. Up front, our Process Development group can screen production strains to select a cell line that will efficiently provide the best possible expression of your drug substance. We develop processes to take advantage of methods, such as high cell density fermentation, to increase product yield and manufacture the best quality product in the most efficient way possible. In creating a manufacturing process suitable for cGMP production, Althea’s process scientists take a modular, Design Of Experiment (DOE) based approach to develop optimal fermentation and product recovery processes, as well as downstream purification steps. The Process Development group works hand-in-hand with our Protein Analytical group to ensure the integrity of your molecule each step of the way. In addition, our Process Sciences group manages the Technology transfer of the process from the Process Development group to the cGMP Manufacturing group to provide seamless transfer of your manufacturing process into the cGMP manufacturing facility.
An example of the technology and techniques we deploy within our Process Development group is demonstrated through our use of the Delta V system with a Finesse TrueBio software overlay. This system allows our Process Development scientists to track, measure, and adapt process parameters so that process changes and scale up can be done easily and quickly for subsequent phases of development and commercialization. With the fermentation capacity to carry you through commercialization and the Process Sciences team to ensure optimal production of your drug substance, Althea can be your strategic partner for the production of your cGMP drug substance.
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Fermentation optimization for the soluble, periplasmic production of a therapeutic protein:chaperone complex was performed. A three step purification method was then developed which maintained the integrity of the complex. This process was then transferred, manufactured and filled in our cGMP facility for clinical trial use.