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Throughout the entire production process of blood product, the key steps include: precipitate preparation, separation and clarification, chromatography purification, ultrafiltration, virus inactivation/removal, and sterilizing filtration. The low-temperature ethanol process is employed for precipitate preparation, followed by depth filtration to achieve separation. This is an method widely used for plasma protein separation. The principle lies in the varying solubility of proteins under different ethanol concentrations, temperatures, and pH levels. Ethanol significantly reduces the dielectric constant of protein aqueous solutions, thereby decreasing protein solubility.
Cobetter have launched Roheap CSD depth filter sheets for blood product fraction separation/clarification filtration. To date, these have undergone multiple rounds of pilot-scale validation in nearly 10 enterprises, which fully verifies the product's stability, reproducibility, and scalability in practical processes. Five blood product manufacturers have successfully implemented Cobetter Roheap CSD depth filter sheets in the GMP production processes of core products such as Human Serum Albumin (HSA) and Intravenous Immunoglobulin (IVIG), achieving a smooth transition from validation to commercial production.
In this article we will share some typical case studies to demonstrate the successful applications and technical advantages of Cobetter Rosheap CSD depth filter sheets in the real production scenarios.
Case Study 1
Filter type: Cobetter DEBL50 Depth Filter Sheets
Scale-up validation process: from Bench scale to pilot to GMP production
Bench Scale
Using 48mm Cobetter DEBL50 depth filter and competitive products to make a comparative small-scale filtration performance study under identical conditions. By monitoring parameters such as turbidity, pH, and conductivity of the filtered product, it was preliminarily determined that Cobetter DEBL50 filter sheet exhibited comparable turbidity control performance to the competitive.
Pilot Scale
After initially confirming by a bench-scale test that the turbidity control performance of Cobetter DEBL50 filter sheet is basically the same as that of the competitor’s, using a 200mm*200mm Cobetter filter sheet for a scale-up test to examine the filtration capacity. Pilot test can be carried out in the pilot plant for scale-up verification.
GMP Production
Based on the results of bench-scale and pilot-scale test, the feasibility of using Cobetter DEBL50 filter sheet in fraction separation has been determined. GMP production validation can be carried out to examine the filtration performance of the Cobetter filter sheets on a process scale.
Final Product Quality Testing Results for Human Serum Albumin
Through progressive scale-up validation, Cobetter DEBL50 filter sheets demonstrated excellent performance at the human serum albumin fraction separation stage, with performance largely consistent with that of competitive products.
Case Study 2
Filter type: Cobetter DEBL50 and CEBLS4 Depth Filter Sheets, 773*773mm square
Validation process: GMP production
Final Product Quality Testing Results for Human Serum Albumin
Final Product Quality Testing Results for Intravenous Immunoglobulin
Through GMP production validation, Cobetter DEBL50 filter sheets demonstrated excellent filtration performance at the Fraction III separation stage, while the CEBLS4 model performed excellently at the Fraction II and Fraction V separation stages. The performance of both was largely consistent with that of competitive products.
Cobetter Roheap CSD CE series is manufactured from high-purity wood cellulose and contains no mineral components, good to enhanced biosafety. Cobetter Roheap CSD DE series employs a specialized process to composite high-purity cellulose with inorganic filter aids, forming a three-dimensional deep-layer structure that delivers excellent filtration performance and high dirt-holding capacity, making it suitable for various process scenarios. Both types exhibit low levels of extractables, metal leachables, and endotoxins, complying with the stringent safety and purity requirements of biopharmaceutical processes and providing reliable support for the stable production of blood products.
