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Cobetter Sterilizing-grade Filters: Novel Application in Pneumococcal Vaccine Process

2025.12.09 33

Streptococcus Pneumoniae

Streptococcus Pneumoniae is a Gram-positive diplococcus and an important pathogen causing infectious diseases such as lobar pneumonia, meningitis, otitis media, and bronchitis. Based on differences in the antigenicity of its capsular polysaccharides, Streptococcus Pneumoniae can be classified into more than 90 serotypes. In adults, pathogenic strains are mainly concentrated in serotypes 1 to 9 and 12, while in children, serotypes 6, 14, 19, and 23 are more common and represent high-incidence serotypes for pediatric pneumonia and invasive diseases.

Vaccination against pneumococcal disease is one of the most cost-effective public health measures for preventing related illnesses in infants and young children. In recent years, driven by increased global emphasis on disease prevention and the adoption of combination vaccines, the pneumococcal vaccine market has continued to expand, demonstrating significant growth. However, the continuous development and launch of higher-valent vaccines (e.g., 13-valent, 15-valent, 20-valent, and even 23-valent) have led to more complex formulations, higher antigen concentrations, and consequently, increased fluid viscosity and impurity levels. This poses unprecedented challenges for the downstream sterile filtration process, where conventional filters increasingly face issues such as rapid fouling, significant flux decline, and low product yield.

Cobetter introduces the Purcise® SLT pharmaceutical-grade sterilizing filter. It incorporates a built-in, sterilizing-grade hydrophilic PES membrane, which exhibits excellent properties including low protein adsorption, low cytotoxicity, and high chemical resistance. This filter is not only ideal for the sterile filtration of conventional culture media but is also specifically optimized for challenging, high-value fluids such as vaccine drug substances and polysaccharide conjugates. It demonstrates excellent throughput and retention capabilities, thereby providing reliable assurance for the efficient and stable production of complex vaccine formulations like pneumococcal vaccines.

Case Study 1

Final Sterile Filtration of Type 2 Pneumococcal Polysaccharide Conjugate Vaccine (Constant Flow Filtration, Final Pressure Difference: 1.0 bar)

Case Study 2

Final Sterile Filtration of Type 18-C Pneumococcal Polysaccharide Conjugate Vaccine (Constant Flow Filtration, Final Pressure Difference: 0.2 bar)

Case Study 3

Final Sterile Filtration of Type 19-A Pneumococcal Polysaccharide Conjugate Vaccine (Constant Flow Filtration, Final Pressure Difference: 0.2 bar)

The above test results demonstrate that:

In the sterile filtration processes for different serotypes of pneumococcal polysaccharide conjugate vaccines, filtration difficulty varies due to differences in antigen structure, molecular weight, and feed fluid viscosity among the various serotypes. This imposes higher demands on the flux, loading capacity, and retention of the filter membrane. Cobetter Purcise® SLT series pharmaceutical-grade hydrophilic PES filters exhibit excellent and consistent filtration performance, making them suitable for a wide range of applications—from low-viscosity fluids to highly challenging feed streams.

Whether processing high-concentration polysaccharide conjugates prone to fouling or complex multivalent vaccine bulk solutions, Cobetter SLT membrane exhibits significantly higher capacity per unit area compared to conventional PES membranes and leading competitive products. While ensuring efficient sterilizing-grade retention, they substantially extend filtration run times, reduce the frequency of filter change-outs, and enhance overall process efficiency.