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. With the industry moving toward higher titers, a key challenge in cell harvesting is how to deal with higher cell densities. The higher titers and densities have created growth opportunities for filtration technologies that can handle the large amounts of cell mass.

Over the past decade, most biopharmaceutical companies have addressed challenges in H & C by taking a proactive approach to mapping end-to-end workflows and tightly defining success outcomes. Most companies generate detailed feedstock characteristics (nature of protein, etc.) and volume (filter capacity targets, etc.) to set targets on yield, impurity removal level and processing time.

To develop an efficient harvest and clarification process, a dynamic approach based on new technologies that facilitate robust integration of multiple steps is needed.

Single-use centrifugation, depth filtration, sonication and flocculants or body feed-based unit operations may reduce the contaminant load and help generate higher purity harvest. Depth filtration and membrane (sterile) filtration facilitate further removal of debris, while chromatography filters permit a cleaner Protein A elutant.

These solutions may enable optimization unit processes and deliver filtration consistency to protect downstream unit operations while reducing operating costs.