Platform downstream process development approaches are frequently used with mAbs, antibody derivatives and Fc-fusion proteins to simplify early stage process development and minimize time to clinic.  The more divergent a molecule is from a mAb in terms of charge, stability, conformation, glycosylation and hydrophobicity, the more development effort will be required using a platform purification approach to achieve the desired product quality and safety profile for the clinical BDS material.  This presentation will discuss the purification processes developed for two different Fc-fusion proteins: one which showed good performance using a platform purification approach and a second that required multiple modifications to the purification strategy to achieve the desired product quality profile.

Application and adaptation of platform and alternative purification steps to two different Fc-Fusion Proteins

2019 Spring National Meeting

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