Methods for addressing host cell protein impurities in biopharmaceutical product development

Area of Science:

• Biopharmaceutical Manufacturing
• Protein Purification
• Antibody Therapeutics

Background:

• Monoclonal antibody (mAb) therapeutics are in high demand, driving efforts to reduce manufacturing costs.
• The purification process accounts for a significant portion (50%-80%) of total mAb manufacturing expenses.
• Host cell proteins (HCPs) are a major challenge, co-purifying with mAbs and potentially degrading the final product.

Purpose of the Study:

• To review established and novel techniques for improving host cell protein (HCP) clearance during mAb production.
• To discuss strategies for enhancing HCP reduction to improve the quality and stability of mAb therapeutics.
• To provide insights into optimizing both upstream and downstream processes for better HCP removal.

Main Methods:

• Review of current literature on mAb purification techniques.
• Analysis of established methods for HCP removal.
• Exploration of emerging technologies and novel approaches for HCP clearance.

Main Results:

• Identified HCPs as a critical factor impacting mAb manufacturing costs and product quality.
• Evaluated various techniques for HCP reduction across different manufacturing stages.
• Highlighted the potential of new methods to significantly improve HCP clearance over existing strategies.

Conclusions:

• Effective HCP clearance is crucial for reducing mAb manufacturing costs and ensuring product integrity.
• A combination of established and innovative techniques can optimize HCP removal.
• Advancements in HCP clearance methods promise to enhance the quality and stability of mAb therapeutics.