1. What Is Chromatography-Based Plasma Fractionation?
Chromatography-based plasma fractionation is a modern method used to separate valuable plasma proteins—such as Immunoglobulin (IgG) and Albumin—from human plasma.
It replaces the older Dr. Cohn cold ethanol method, offering higher purity, higher yields, and faster processing.

2. Why Chromatography Instead of Cohn Method?
The traditional Cohn process uses cold ethanol precipitation, which:

• Damages proteins

• Produces more waste

• Takes longer

• Gives lower yields

Chromatography solves these issues by separating proteins using specialized resins and controlled flow, resulting in cleaner, more efficient recovery.

3. Key Advantages (Explained Clearly)
A. Higher Protein Yields
Chromatography recovers more proteins per liter of plasma:

• 8.5 g/L Immunoglobulin (IgG)

• 23 g/L Albumin

This means more final product from the same amount of plasma.
B. Faster Process Cycle

• Complete batch cycle: 3 days

• Possible output: Up to 55 batches per month

This makes production faster, predictable, and more efficient.
C. Scalable Systems
Capacity options:

• 100 L

• 200 L

• 400 L

• And larger custom systems

Suitable for:

• Pilot facilities

• Medium-scale plants

• Full commercial manufacturing

D. Cleaner Protein Separation
Chromatography provides:

• Higher purity

• Lower impurities

• Less protein loss

• Reduced ethanol and chemical handling

This results in safer, cleaner, and more stable final drugs.

4. Products Produced Through Chromatography
Common plasma-derived products include:

• Albumin

• Immunoglobulin (IVIG / SCIG)

• Clotting factor concentrates

• Fibrinogen
   

5. Regulatory Standards & Compliance
Our chromatography-based systems meet major global regulatory requirements:

• WHO-GMP

• CDSCO (India)

• EMA (Europe)

• US-FDA (USA)

This ensures:

• Audit readiness

• Documentation compliance

• International market eligibility
   

6. Why This Technology Matters
Chromatography-based plasma fractionation provides:

• Better quality of life-saving plasma drugs

• Lower production cost per gram

• Higher efficiency for manufacturers

• Reduced risk of batch failures

It is now considered the most advanced, efficient, and scalable plasma processing technology.