Downstream Processing: Refining Biologics for Therapeutic Use

What Downstream Processing Is

Downstream processing (DSP) is a series of purification steps that follow upstream processes in the production of therapeutic proteins. These steps aim to remove impurities, contaminants, and other unwanted substances from the biologic product while ensuring its stability and efficacy.

The process typically includes capture, polishing, and viral filtration stages, each designed to address specific challenges in achieving a high-quality final product.

Why It Matters

DSP is crucial for producing safe and effective biologic drugs. By meticulously purifying the biologic substance, DSP ensures that the final product meets stringent regulatory standards and is free from contaminants that could cause adverse reactions or reduce its therapeutic efficacy.

Moreover, efficient DSP can significantly enhance yield, making it a vital component in reducing production costs and increasing the availability of these life-saving treatments.

The Process Stages

Capture is the initial stage where the biologic substance is isolated from its cellular environment. This often involves affinity chromatography, where specific ligands bind to the target protein, allowing for selective isolation.

Polishing follows capture and aims to further refine the product by removing any remaining impurities or unwanted proteins. Techniques such as ion exchange, size exclusion, and hydrophobic interaction chromatography are commonly used in this stage.

Viral Filtration

The final stage of DSP is viral filtration, which involves using membrane filters to remove any potential viral contaminants that might have survived the previous purification steps. This step is critical for ensuring the safety of biologic drugs.

By employing advanced filtration technologies, DSP can effectively reduce the risk of transmitting infectious agents, thereby safeguarding patients and healthcare workers.

Frequently asked questions

Try it live

Everything above runs in your browser — open Downstream Processing (DSP) and change the parameters while it is running. Nothing is installed, nothing is uploaded, the whole model lives in one tab.