APPLICATION NOTE

Addressing Host Cell Protein Challenges in Monoclonal Antibody Production

Host Cell Proteins and Their Impact

HCPs, produced by host cells like Chinese Hamster Ovary (CHO) cells, can impact product quality and pose regulatory concerns. Efforts are made to limit HCP levels to a maximum of 100 ppm to avoid adverse immune responses in patients.

Approaches to Mitigate HCP Challenges

Ecolab employs a quality by design (QBD) approach to ensure product quality. Techniques such as post-harvest clarification and Protein A affinity chromatography are used to effectively remove HCPs.

Praesto Jetted A50 HipH for Enhanced HCP Removal

Ecolab's Praesto Jetted A50 HipH resin allows for higher pH elution, reducing aggregation and enhancing product purity. Studies show it significantly increases HCP clearance compared to traditional protein A resins.

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