Speed to IND is often a key driver in developing manufacturing processes for early clinical trials. Once a drug candidate is in the clinic, process development activities are typically ceased until positive clinical signal is obtained, then further process development is initiated to enable late stage development and commercialization of the product. Process set-points and/or parameters can change between early and late stages of development, and ensuring consistent product quality profile before and after process change can be challenging. In order to allow for late stage cell culture development and optimization, a greater understanding of process-to-product is required.<br/><br/>To support the advancement of process-to-product understanding, definitive screening design (DSD) methodology was used in a case study to effectively assess the combinatorial impacts of media supplements on monoclonal antibody production and glycan product quality. Fifteen chemical supplements were evaluated, and several supplements were identified to modulate the N-glycan distributions. Leveraging these chemicals along with newly identified cell culture process manipulations, it was found that mAb titer could be significantly improved while maintaining similar N-glycan distributions. These findings enhanced our process-to-product understanding and have allowed for more freedom in commercial process development.

Achieving desired monoclonal antibody product quality attributes throgh cell culture process manipulations

253rd National Meeting (2017)

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