(787f) Levers to Modulate Product Quality Attributes of Product-a in CHO Cell Culture

Levers to modulate two product quality attributes were investigated as part of process development of Product-A produced in Chinese Hamster Ovary (CHO) cell culture. The addition of a chelating agent to the cell culture fluid was identified as a lever to minimize product fragment formation which indicates that metallo-proteases could potentially be contributing to fragment formation. A study to understand the nature and formation of product size variants identified that aggregate formation was predominantly intracellular and occurred prior to secretion and the fragments were formed in the cell culture fluid after secretion. In addition, media additives and process conditions were evaluated for potential levers to modulate product quality attribute-2. Process parameter-1 was determined to be a robust lever for controlling product quality attribute-2 across various production scales.