Tuesday, July 28, 2009 - 2:00 PM
S79

High Protein-titer Bioprocesses in a Contract Development and Manufacturing Organization: Product Quality as a Function of Culture Trajectory

Jason Dowd, ., Projects & Process Development, QSV Biologics,, 9411 20th Avenue, Edmonton, AB T6N 1J3, Canada

Producing multiple biologics in a contract facility presents a challenge, where there is a client expectation of quality and speedy delivery of high value biologics.  The process development framework needs to be efficient to obtain the data set required to proceed with larger scale production and responsive to the risk profile of the client.  Given the wide range of quantities required due to clinical trial phase and indication, several platform processes have been developed to satisfy clinic needs, typically fed-batch and perfusion bioprocesses.  In these high-titer bioprocesses, increasing focus is on the culture trajectory – how does the culture (and protein product) arrive at the point of harvest.  Protein product can be viewed as a yield of product from substrate.  However, the pool of recombinant protein is produced at various stages in the culture, in early stages with good viability and substrate excess, while in later stages with perhaps low viability and substrate limitations.  Within this culture trajectory, the cellular state for production can shift widely, even in well-controlled bioprocesses.  The final product concentration can be calculated as an integration with respect to time of the cell density multiplied by the specific productivity at that culture point.    The focus of this work is to present case examples of product quality as a function of culture trajectory – where to harvest to ensure that product quality is acceptable and amenable to robust purification.   


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