Cobetter Roheap CSD Depth Filter Sheets Performance in Blood Products Separation

Blood products refers to plasma protein components and blood cells that produced by separating, purifying or using recombinant DNA technology from healthy or specially immunized human plasma. When the industry says blood products, it refers to human plasma protein products.

The blood products raw plasma can be divided into five components (i.e. components I, II, III, IV, V). The low-temperature ethanol process is used for component precipitation preparation, then the filter plate is used for component separation. The separated component I can be used to prepare human fibrinogen; component II can be used to prepare immunoglobulin preparations; component V can be used to prepare human serum albumin. The simplified flowchart of component separation is shown in Figure 1. What’s more, the fourth generation intravenous  immunoglobulin prepared by the octylic acid precipitation process can also achieved solid-liquid separation by filter plate through pressure. 

Cobetter Filter Plate Types and Applications

For different separation sites of plasma components, Cobetter has launched Roheap CSD DE series and Roheap CSD CE series filter plates. Among them, the Roheap CSD DE series filter plates are composed of high-purity cellulose and inorganic filter aids, while the Roheap CSD CE series filter plates are made from high-purity cellulose. The specific types can be referred to in Table 1 below.

Table 1. Cobetter Roheap CSD DE, CE Series Filter Plates

At present, Cobetter Roheap CSD DE and CE series depth filter plates have undergone extensive testing with our clients and have many successful case studies. The application of different filter plates in component separation can be referred to in Table 2.

Table 2. Cobetter Roheap CSD DE, CE Series Depth Filter Plates Applications

Comparison between Cobetter filter plate and competitor’s filter plate 

At present, filter plates for component separation in the blood products industry are mostly imported products. In order to facilitate user comparison and research, Cobetter has conducted comparative studies with competing filter plates in various aspects.
Take our most widely-used DEBL50 filter plate as an example, comparative studies were conducted with competitor’s filter plates in terms of specifications, filtration performance, metal leachables and particles shedding. 

1. Comparison of specifications between Cobetter DEBL50 filter plate and competitor’s filter plate

Detailed comparison of specifications are shown in Table 3. 

Table 3. Comparison of Specifications

2. Comparison of filtration performance between Cobetter DEBL50 filter plate and competitor’s filter plate

2.1 The fourth generation intravenous immunoglobulin - Octylic Acid Solid-liquid separation

The feed solution of component I + II + III dissolved in octylic acid, was separated by Cobetter DEBL50 filter plate and competitor filter plate. The detailed comparison results are shown in Table 4 and Figure 2.

 Table 4. Comparison of Octylic Acid Precipitation Solid-liquid Separation

Figure 2. Octylic Acid Precipitation Solid-liquid Separation

2.2 Human albumin - Component IV separation

Using the separated liquid of components I+II+III to carry out the separation of component IV. A pilot test was conducted by Cobetter 200 * 200mm DEBL50 filter plate, which was synchronized with the commercial production line of competitor 773 * 773mm filter plate. The detailed comparison results are shown in Table 5 and Figure 3.  

Table 5 & Figure 3. Component IV separation

3. Comparison of metal leachable between Cobetter DEBL50 filter plate and competitor’s filter plate after water flushing

Using Cobetter DEBL50 and competitor’s filter plate, rinse with purified water at a constant flow rate of 400LMH until 0L/m2, 10L/m2, 50L/m2, and 100L/m2. Collect the rinsing water in clean PFA bottles for test and analysis. The results are shown in Table 6. 

Table 6. Comparison of Metal Leachables

4. Comparison of particle shedding between Cobetter DEBL50 filter plate and competitor’s filter plate

Using Cobetter DEBL50 and competitor’s filter plate, rinse with purified water at a constant flow rate of 400LMH at 140L/m2. Detect the number of insoluble particles with sizes ≥10μm and ≥25μm in the downstream filtrate online. The results are shown in Figure 4.

Figure 4. Comparison of Particles Shedding

Conclusion

Cobetter Roheap CSD DE, CE series filter sheets have been tested on various scales of plasma separation, including lab, pilot and commercial production in several blood products companies. The test results show that the performance of Cobetter blood products separation filter plate is consistent with that of foreign competitors.