Purcise™ Q Membrane Adsorbers and Traditional Resins in Anion Exchange Chromatography for Antibody Purification

In today's pharmaceutical market, approved antibody drugs can generally be categorized into two common types: monoclonal antibodies and multispecific antibodies. The first step in the downstream bioprocessing of these antibody drugs often involves the use of Protein A affinity chromatography to effectively separate the target product from various impurities. After this step, the product purity can increase to 95% or higher. The subsequent second step is polishing chromatography, which focuses on removing residual impurities (such as host cell proteins (HCP), DNA, Protein A residues, viruses, endotoxins, aggregates, etc.) to obtain a higher purity target molecule. Typically, anion exchange chromatography is a commonly used step in antibody polishing.

Since the isoelectric points (pI) of most antibody molecules are neutral to alkaline, while impurities such as the majority of host cell proteins (HCP), host cell DNA (HCD), Protein A residues, viruses, and endotoxins typically exhibit acidic isoelectric points, anion exchange chromatography is usually operated in flow-through mode to remove these acidic impurities.

Traditional anion resin chromatography is typically used for anion exchange processes. However, with the introduction of Cobetter Purcise™ Q Membrane Adsorber (Chromatography), it has demonstrated significantly superior performance compared to traditional resins in antibody anion purification processes. Next, we will compare and introduce the application of Cobetter Purcise™ Q membrane adsorber (chromatography) in the purification process of antibody anions through three case studies. 

Case Study 1: Performance Comparison of Anion Exchange Chromatography for a Monoclonal Antibody

Material Information:

Monoclonal antibody, concentration 10.7 g/L, pH 7.0, conductivity 5.4 mS/cm.

Chromatography Media:

(1) Cobetter Purcise™ Q Membrane Adsorber (Chromatography), bed volume 0.9 mL, Part No.: CXD32EAQ16CC1P.
(2) Anion resin from a specific manufacturer, column volume 4.6 mL.

Process Parameters:

(1) For Cobetter Purcise™ Q Membrane Adsorber (Chromatography): process flow rate 9 mL/min, retention time 6 s, loading capacity 2000 g/L, fraction collection.
(2) For the specific manufacturer's anion resin: process flow rate 0.92 mL/min, retention time  5 min, loading capacity 120 g/L.
(3) Process duration: Purcise™ Q Membrane Adsorber (Chromatography) <1 h; specific manufacturer's resin 2–3 h.

Performance Comparison:

Experimental Conclusion of Case Study 1:

Based on preliminary testing results for this monoclonal antibody material, the Purcise™ Q Membrane Adsorcher (Chromatography) achieves purification efficacy at a loading capacity of 2000 g/L comparable to that of traditional resin at 120 g/L, with comparable HCP residual levels and yield performance to resin chromatography.

Case Study 2: Performance Comparison of Anion Exchange Chromatography for a Bispecific Antibody

Material Information:

Bispecific antibody, concentration 6.0 g/L, pH 7.0, conductivity 5.4 mS/cm.

Chromatography Media:

(1) Cobetter Purcise™ Q Membrane Adsorber (Chromatography), bed volume 0.9 mL, Part No.: CXD32EAQ16CC1P.

(2) Anion resin from a specific manufacturer, column volume 5 mL.

Process Parameters:

(1) For Cobetter Purcise™ Q Membrane Adsorber (Chromatography): process flow rate 9 mL/min, retention time 6 s, loading capacity 2000 g/L, fraction collection.
(2) For the specific manufacturer's anion resin: process flow rate 1 mL/min, retention time 5 min, loading capacity 120 g/L.
(3) Process duration: Purcise™ Q Membrane Adsorber (Chromatography) <1 h; specific manufacturer's resin 2–3 h.

Performance Comparison:

Experimental Conclusion of Case Study 2:

Based on preliminary testing results for this bispecific antibody material, the Purcise™ Q Membrane Adsorcher (Chromatography) achieves purification efficacy at a loading capacity of 2000 g/L comparable to that of traditional resin at 120 g/L, with comparable HCP residual levels and yield performance to resin chromatography.

Case Study 3: Performance Comparison of Anion Exchange Chromatography for a Bispecific Antibody

Material Information:

Bispecific antibody, concentration 23.0 g/L, pH 6.7, conductivity 3.5 mS/cm.

Chromatography Media:

(1) Cobetter Purcise™ Q Membrane Adsorber (Chromatography), bed volume 0.9 mL, Part No.: CXD32EAQ16CC1P.
(2) Anion resin from a specific manufacturer, column volume 5.3 mL.

Process Parameters:

(1) For Cobetter Purcise™ Q Membrane Adsorber (Chromatography): process flow rate 9 mL/min, retention time 6 s, loading capacity 350 g/L, fraction collection.

(2) For the specific manufacturer's anion resin: process flow rate 0.88 mL/min, retention time 6 min, loading capacity 90 g/L.
(3) Process duration: Purcise™ Q Membrane Adsorber (Chromatography) <0.5 h; specific manufacturer's resin 2–3 h.

Performance Comparison:

Experimental Conclusion of Case Study 3:

For this bispecific antibody material, the Purcise™ Q Membrane Adsorber (Chromatography) can still achieve the same level of HCP removal capacity as the resin chromatography under the same, 2 times or 4 times loading capacity (90mg/ml) conditions. In all scenarios, HCP levels are effectively controlled below 10 ppm.

Conclusion

Based on the three case studies above, Cobetter Purcise™ Q Membrane Adsorber (Chromatography) demonstrates the following advantages in anion exchange purification processes for both mAb and BsAb materials:

1. It delivers comparable impurity removal performance to traditional resin chromatography.
2. While achieving comparable impurity clearance, it provides an order-of-magnitude increase in loading capacity compared to traditional resin chromatography.
3. It features simple and straightforward operation with high loading flow rates, significantly reducing process time and improving production efficiency. This translates to a fundamental enhancement in cost control for both clinical and commercial production.