Separate Insulin Impurities

Separation strategy for removing Insulin aggregates and impurities using Size Exclusion Chromatography.

Recommended technique

Size Exclusion Chromatography Best Match

Separation handle: Buffer exchange, aggregate removal.

Scope: Size-based. CAPEX range: $150k-$1M.

Property comparison

PropertyInsulinInsulin
Molecular weight5808 Da5808 Da
Solubility (water)25 g/L25 g/L
Charge-4-4
Isoelectric point5.35.3
pKa5.35.3
Density1.34 g/cm³1.34 g/cm³
Diffusion coefficient1.50e-06 cm²/s1.50e-06 cm²/s
Log P

Process design walkthrough

1

Define your feed stream

Set Insulin and Insulin as components with their concentrations and physical properties. Use the molecule database to auto-populate properties.

2

Drop in Size Exclusion Chromatography

Connect the feed inlet, configure operating parameters (MWCO, pH, eluent, residence time as relevant), and connect the two outlets to product and waste streams.

3

Run the simulation

untangle.bio calculates outlet concentrations using mass balance and the separation function for this technique. Iterate on parameters to optimise yield vs purity.

4

Add polishing if needed

If the single step doesn't meet your purity spec, add a second separation with a complementary handle (e.g., size after charge, hydrophobicity after size).

Frequently Asked Questions

Why is Size Exclusion Chromatography the right choice for this pair?

Size Exclusion Chromatography exploits buffer exchange, aggregate removal as the separation handle. The property gap between Insulin and Insulin on this axis is large enough to give a clean separation in a single step at industrially relevant flow rates.

What yield and purity can I expect?

Typical single-step recovery is 85-99% depending on operating conditions. Purity from a single size exclusion chromatography step is in the 90-99% range; polishing steps push above 99.5%.

What does this step cost to operate?

Capital cost for Size Exclusion Chromatography at biotech scale is in the $150k-$1M range. Operating cost depends on scale, feed concentration, and product value. See the technique page for details.

How do I design this in untangle.bio?

Drop a size exclusion chromatography unit operation into the flowsheet, connect the feed stream containing both Insulin and Insulin, and the simulator will calculate mass balance and expected outlet concentrations using the molecule database properties.

Design this separation in untangle.bio

Build a flowsheet, simulate yield and purity, and estimate CAPEX for separating Insulin from Insulin.

Open untangle.bio

Related pages

Read more