Why is downstream processing currently a point of failure?

While upstream titers (the amount of product produced in a bioreactor) have increased tenfold over the last decade, downstream processing (DSP)—the purification and harvesting phase—has not kept pace. This "mismatch" creates a bottleneck where high-volume output from bioreactors is slowed by the physical limits of traditional chromatography columns and filtration membranes.

For bioprocess strategists, resolving this bottleneck is the fastest route to increasing facility capacity. The cost of protein-A resins and the time required for multiple purification cycles represent a major portion of the total cost of goods sold (COGS), making DSP innovation a high-priority investment area.

Are High-Throughput Purification Technologies gaining traction?

In 2024, the bioprocess market is seeing a heavy shift toward High-Throughput Purification Technologies. Membrane chromatography and fiber-based systems are replacing resin beads in several process steps, offering much higher flow rates and reduced buffer consumption. For consultants, the value proposition lies in the reduction of "non-productive" time—such as column packing and cleaning validation—which can account for up to 40% of downstream labor costs.

What is the outlook for 2024/2025?

Through 2025, we expect to see the rise of "flocculation" and advanced precipitation techniques as alternatives to primary filtration. Furthermore, the integration of Process Analytical Technology (PAT) directly into purification skids will allow for automated peak cutting and fraction collection, moving the industry closer to the goal of "autonomous purification."

• Adoption of continuous chromatography to reduce resin volume requirements.
• Use of AI-driven modeling to predict impurity profiles.
• Expansion of specialized filtration for viral vector purification.

Author: Sofiya Sanjay

Designation: Healthcare Research Consultant, Market Research Future

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