Vaccine Research
Preliminary stability study on characterization of aluminum phosphate adjuvant
Miao Chenyang, Hui Manjun, Zhang Jumei, Shen Weiwei, Li Wei, Wei Jian
Published 2022-10-10
Cite as Int J Biologicals, 2022, 45(5): 251-256. DOI: 10.3760/cma.j.cn311962-20220120-00007
Abstract
ObjectiveTo study the characterizations of self-made aluminum phosphate adjuvant under different conditions.
MethodsThree batches of industrialized aluminum phosphate adjuvants were used to detect the isoelectric point, phosphorus-aluminum ratio, pH value, maximum adsorption capacity, surface charge, sedimentation rate, particle size and distribution under different sterilization times and room temperature storage time.
ResultsAfter sterilized for three times, the isoelectric points of three aluminum phosphate adjuvants were 4.6±0.2, phosphorus aluminum ratios were 0.9±0.1, pH values were 7.3±0.1, Zeta potentials were (-13±2) mV, the maximum adsorption capacity of HPV16 L1 antigen was 4 times, the sedimentation rates were 21%±1%, 90% particle size distribution (Dv90) values were (15.5±0.5) μm, Dv50 values were (6.0±1.0) μm, and Dv10 values were (1.5±0.5) μm. After storing at room temperature for 2 years, the isoelectric points of three aluminum phosphate adjuvants were 4.6±0.2, phosphorus aluminum ratios were 0.9±0.1, pH values were 7.4±0.1, Zeta potentials were (-13±3) mV, the maximum adsorption capacity of HPV16 L1 antigen was 4 times, the sedimentation rates were 21%±1%, Dv90 values were (18.0±4.0) μm. Dv50 values were (6.0±1.0) μm, and Dv10 values were (1.0±1.0) μm. All items met the requirement.
ConclusionsThe quality of aluminum phosphate adjuvant can be stable after sterilized for 3 times and stored at room temperature for 2 years. Through this study, the evaluation platform of aluminum phosphate adjuvant has been established to ensure the continuous and safe use of self-made aluminum phosphate adjuvant.
Key words:
Aluminum phosphate adjuvant; Characterizations; Stability
Contributor Information
Miao Chenyang
Formulation Development Department, Shanghai Zerun Biotechnology Co., Ltd., Shanghai 201203, China
Hui Manjun
Formulation Development Department, Shanghai Zerun Biotechnology Co., Ltd., Shanghai 201203, China
Zhang Jumei
Formulation Preparation Workshop, Yuxi Zerun Biotechnology Co., Ltd., Yuxi 653199, China
Shen Weiwei
Quality Control Laboratory, Yuxi Zerun Biotechnology Co., Ltd., Yuxi 653199, China
Li Wei
Quality Control Laboratory, Yuxi Zerun Biotechnology Co., Ltd., Yuxi 653199, China
Wei Jian
Formulation Development Department, Shanghai Zerun Biotechnology Co., Ltd., Shanghai 201203, China
