Optimization of clarifying filtration and ultrafiltration concentration process for harvest solution of Coxackievirus A16
10.13200/j.cnki.cjb.004617
- VernacularTitle:柯萨奇病毒A组16型病毒收获液澄清过滤与超滤浓缩工艺的优化
- Author:
Xiaowei LU
1
Author Information
1. Aimei Action Biopharmaceutical Co., Ltd.,Taizhou 225300, Jiangsu Province, China
- Publication Type:Journal Article
- Keywords:
Coxackievirus A16(CAl6) concentrated liquid;
Ultrafiltration concentration;
Antigen recovery rate;
Protein removal rate
- From:
Chinese Journal of Biologicals
2025;38(12):1498-1503
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate a technical approach suitable for the clarification and concentration of Coxackievirus A16(CA16) harvest solution, aiming to effectively remove impurity particles and proteins while achieving high antigen concentration.Methods The virus harvest solution underwent two-stage filtration pretreatment. Antigen recovery rate,membrane flux, and turbidity were utilized as evaluation metrics at each stage to examine the effects of various membrane materials, pore sizes, and structures on clarifying efficacy. Subsequently, clarified harvest liquid was concentrated using a100 KD polyether sulfone membrane, and the changes in antigen content and protein content were analyzed to determine the optimal concentration multiples, washing cycles, and sampling intervals. The sample size was scaled up for pilot testing where the harvested liquid was clarified, filtered and subjected to ultrafiltration based on the optimized parameters. The linear scalability of this process was assessed using antigen recovery rates and protein removal rates as indicators.Results In the first stage, 0. 45 ??m glass fiber membranes were employed while in the second stage 0. 45 ??m polyether sulfone membranes were used. The optimal conditions for ultrafiltration concentration included a concentration factor ranging from 30 to50 times with four washing filtrations followed by four sampling collections. At pilot scale testing, post-clarification resulted in a turbidity reduction of CA16 virus by 96. 00%, with an antigen recovery rate of 89. 49%. Following ultrafiltration concentration yielded an antigen recovery rate of 87. 23% alongside a protein removal rate reaching 91. 17%.Conclusion The optimized ultrafiltration concentration technology not only reduces protein content but also achieves high levels of antigen recovery while demonstrating excellent potential for linear amplification.
