Various additives and excipients such as buffers, salts, carbohydrates, surfactants are use in biopharmaceutical manufacturing to enable processing and protecting therapeutic molecule from undergoing undesired physical and chemical changes during processing and handling. These materials are used as process additives and excipient. For example, sucrose is used as process additive in viral vector manufacturing as well as recombinant protein and monoclonal antibody formulation. It is one of the key ingredients that enhance the thermodynamic stability during manufacturing and storage, and also used as a lyoprotectant in the freeze-dried formulations of proteins. The presence of reactive impurities such as metals, particulates, and reducing sucrose in sucrose can lead to a variety of unintended interactions within the product formulation, such as glycation, aggregation, oxidation, and hydrolysis. Therefore, it is important to understand the impact of such reactive impurities coming from sucrose in their manufacturing workflow. This presentation will present case studies to illustrate impact of typical impurities in sucrose on the generation of various product related impurities that can impact safety and efficacy of the therapeutic products.

Enhancing the biologic product quality by understanding and controlling the generation of avoidable product related impurities

ACS Fall 2021

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