Innovative Bioprocessing: Pultrix™ Fibers HCMO and Fibers HCMC Launched Together, Opening a New Era of Single-Step Clarification

From High-Density Cell Culture Broth to Post-Centrifugation Supernatant, the Two Products Provide a Comprehensive Clarification Solution

In biopharmaceutical processing, the efficiency of harvest and clarification steps directly determines the yield and quality of the final products. Faced with increasing complex high-density cell culture systems, the industry urgently needs a more efficient, stable and scalable clarification solution.

Therefore, Cobetter has launched Pultrix™ Fibers HCM depth absorption filters, specially designed for clarifying complex fermentation broths:

• Pultrix™ Fibers HCMO: Suitable for single-step direct filtration of fermentation broth.
• Pultrix™ Fibers HCMC: Specially optimized for filtration of post-centrifugation supernatant.

The two products establish a complete process pathway covering “direct filtration of cell culture broths to post-centrifugation clarification.”They offer biopharmaceutical enterprises an efficient, robust, and scalable single-step clarification experience - truly achieving a one-step leap from complex feedstreams to high-quality clarification.

1. The Two Products Provide a Perfect Combination to Meet Different Process Requirements

2. Technical Highlight: Functionalized PP Fibers Based on AEX Membrane Adsorption Technology

Both products employ synthetic fiber anion-adsorptive grafting technology, using a combination of polypropylene (PP) fibers functionalized with quaternary ammonium (Q) groups of different pore sizes to directly adsorb and remove impurities such as cells, debris, and DNA, achieving precise separation based on electrostatic interactions. Soluble and insoluble impurities interact electrostatically with the positively charged ligands on the fiber matrix, enabling their removal and efficiently retaining various particles generated by cell lysis. Specifically, large-pore PP functionalized fibers can retain cells and debris while, through the anion-exchange mechanism, effectively capturing impurities smaller than 0.5 μm that are difficult to remove with traditional depth or membrane filtration technologies.

Excellent Processing Performance:

The product recovery rate >95%, stable turbidity control <10 NTU, while efficiently removing both soluble and insoluble impurities.

Wide Applicability:

Whether for mAb production from CHO cell cultures or for the clarification of AAV lysates from HEK293 cells, both products deliver outstanding performance, providing robust support for the development of diverse biologics. Featuring alkali-resistant housing, they can be sterilized via cleaning prior to use.

3. Scale-Up Advantage: Seamless Transition from Laboratory to Manufacturing

Another key advantage of Pultrix™ Fibers HCM depth adsorption filters is their excellent scalability. The product line convers a various specifications ranging from laboratory R&D to large-scale production. 

This linear scale-up ability allows process parameters optimized at the laboratory scale to be directly applied at production scale, significantly reducing technology transfer risk and shortening time to market. 

4. Application Example: Outstanding Performance in the Clarification of CHO Cell Fermentation Broth

Case Study 1：

Comparison of Pultrix™ Fibers HCMO depth adsorption filter in a single-step filtration process

Cell density: 25.77 M
Viability：87.9%；
Turbidity：2815 NTU
Solid content：8.7%；
Protein concentration：4.33 g/L

Case Study 2:

Comparison of centrifugate filtered through Pultrix™ Fibers HCMC depth adsorption filters

Cell density: 34.5 M
Viability：85.8%；
Post-centrifugation turbidity：190 NTU

Case Study 3：

Comparison of Pultrix™ Fibers HCMC depth adsorption filter in a two-stage filtration process

Cell density: 24.3 M
Viability：92.5%；
Initial turbidity of fermentation broth：3,240 NTU
Initial HCP level：2,623,269 ppm
HCD：8,017,000pg/mg

5. Why Cobetter Pultrix™ Fibers HCM Depth Absorption Filter

Simplifying Process：Combine multiple steps into a single step, reducing equipment investment and operational complexity.

Improving Product Yield: Recovery rate>95%, significantly enhance production efficiency.

Reducing Cost: Compared to centrifugation and depth filtration, total costs are lower, with reduced consumption of buffers and water.

Easy to Scale-Up: Predictive scalability simplifies process transfer from R&D to production.

Flexible Configuration: Both products can be selected based on existing processes, offering suitable solutions for both new production lines and upgrades of existing ones.

Conclusion

Pultrix™ Fibers HCMO and Pultrix™ Fibers HCMC are fermentation broth clarification solutions developed based on the principle of charge adsorption, specifically designed to address high-challenge clarification needs in biopharmaceutical processes. Whether you require direct processing of high-density cell culture broth or optimize existing centrifugation processes, these filters delivers exceptional clarification performance and significant economic benefits.

In today’s increasingly competitive biopharmaceutical landscape, optimizing processes, reducing costs, improving efficiency, and accelerating time to market have become key determinants of success. Cobetter is committed to providing reliable technological solutions, building an invisible yet robust line of defense for global patient medication safety. The Pultrix™ Fibers HCM series is a highly efficient tool designed to help you stand out in this race—empowering more robust, cost-effective, and scalable clarification processes through innovative technology.