Key Trends Reshaping The Future of Bio-pharmaceutical Harvest & Clarification

Cell harvesting and clarifications are both crucial steps that can have a significant impact on the design of downstream processes. Briefly, the primary goals for harvest and clarification (H & C) operations are to remove cells and cell debris from mammalian cell culture and further purify and clarify the resulting product to capture the mAbs via chromatography downstream.

IMPACT OF PROCESS INTERDEPENDENCIES

As processes change upstream in the pharmaceutical manufacturing workflow, causing variability of cell culture fluid, downstream purification unit operations will be impacted.

Variable cell culture fluid creates a range of negative effects on downstream purification including decreasing overall yield, antibody degradation, and aggregation. Often the variability may not be seen in a single drug product, but instead across a company’s entire drug portfolio, which requires multiple manufacturing platforms or facilities.

Also, not all components of the cell culture fluid are completely removed by a single unit operation.

DOWNLOAD EBOOKS