Development of a desorption method for an aluminum-containing adjuvant recombinant respiratory syncytial virus vaccine
10.13200/j.cnki.cjb.004677
- VernacularTitle:呼吸道合胞病毒含铝佐剂重组疫苗解吸附方法的开发
- Author:
Yuzhu YAO
1
Author Information
1. Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China
- Publication Type:Journal Article
- Keywords:
Respiratory syncytial virus(RSV);
Aluminum adjuvant;
Desorption;
Antigen recovery rate;
Vaccine quality control
- From:
Chinese Journal of Biologicals
2026;39(04):452-460
- CountryChina
- Language:Chinese
-
Abstract:
Objective To develop a desorption method for aluminum-adjuvanted recombinant protein vaccines and apply the method to the pre-treatment process for adsorption rate determination of respiratory syncytial virus(RSV) recombinant vaccine intermediates, involving antigen content quantification.MethodsTwo aluminum adjuvants, aluminum hydroxide(AH) and amorphous aluminum hydroxyphosphate sulfate(AAHS), were combined respectively with RSV preF protein to develop a desorption agent formulation(a mixture of 0. 2 mol/L potassium dihydrogen phosphate and 0. 8 mol/L dipotassium hydrogen phosphate). The effects of different treatment methods on desorption efficiency were investigated. The optimal desorption method was validated for its effectiveness in releasing RSV preF recombinant protein from antigen-adjuvant complexes with different formulations and different protein concentrations. Its applicability was also extended to antigenadjuvant complexes of different proteins.ResultsA desorption method was determined: antigen-adjuvant complex + 1%BSA/PBST + high-concentration phosphate(mixed solution of 0. 2 mol/L potassium dihydrogen phosphate and 0. 8 mol/L dipotassium hydrogen phosphate) mixed at a volume ratio of 1∶1∶2, followed by incubation at room temperature for 0. 5 h.This method combined the interfering effects of high-concentration phosphate ions, bovine serum albumin(BSA), and the nonionic surfactant polysorbate 20 on antigen-adjuvant binding, and achieved complete desorption for four RSV preF antigenadjuvant complexes and antigen-AH adjuvant complexes with three different protein concentrations(60-240 μg/mL). The antigen recovery rates detected by ELISA were all within the range of(100 ± 10)%. Compared to the non-optimized common phosphate desorbent, this method significantly improved the post-desorption antigen recovery rate, verifying its high efficiency and stability. It also demonstrated the important synergistic role of BSA and polysorbate 20 in assisting phosphate during the desorption process. This method was also successfully applied to complexes of another RSV preF recombinant protein(DS-CAV1) and human metapneumovirus(HMPV) preF recombinant protein with AH adjuvant, achieving antigen recovery rates above 90%, proving its certain universality and suggesting its potential application in combined respiratory virus vaccines.ConclusionThe established desorption method achieves highly efficient and stable desorption for recombinant RSV preF antigen-adjuvant complexes with different aluminum adjuvants, different buffer systems, and different protein concentrations. It is also applicable to other RSV preF variants and HMPV preF protein, effectively solving the interference problem of aluminum adjuvants in antigen content detection. This provides technical support for the quality control and production process optimization of recombinant RSV vaccines, and also serves as reference for the development of combined respiratory vaccines and other aluminum-adjuvanted vaccines.
