Solving cost and supply challenges in biopharma downstream processing

Monoclonal antibodies (mAbs) are the dominant therapeutic modality in the biopharmaceutical industry, representing the largest sector of the market. As of 2022, more than 100 mAb therapies have been approved by the FDA – over twice as many as had been approved only 5 years ago. As the demand for mAbs and other therapeutic proteins has increased, so have concerns over cost and supply.

Downstream processing – which accounts for roughly 60 percent of the cost of producing a biologic drug and often takes place over a period of weeks – is particularly challenging because it has not improved and scaled at the same rate as upstream processing has. This is largely due to the complexity of downstream processing, which involves the movement of biological materials through a series of unit operations that include multiple chromatography steps.

Of the numerous components of downstream processing, the following are particularly poised to improve recovery and reduce production costs:

• Additive-enhanced buffers and customized buffer management options
• Mixed-mode chromatography and chromatographic resins with tailored ligands
• Data aggregation to inform process efficiency and supply chain decisions.

Many downstream processing solutions – such as the development of process efficiencies and raw material solutions – necessitate a close relationship between those researching and producing therapeutic proteins and their downstream material suppliers. This collaboration enables suppliers to meet their customers’ needs for tailored solutions and high-quality materials, so that biologics producers can achieve the speed-to-market that today’s biopharmaceutical industry demands.

This article explores the technologies that therapeutic protein manufacturers and their suppliers can leverage to solve downstream processing challenges.

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