Method for preparation of aluminium phosphate gel for application in vaccine formulations
Inventors
Ganapathy, Ravi • Gade, Nagireddy • Manohar, Manish • Paradkar, Vikram Madhusadan • Datla, Mahima
Assignees
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Publication Number
US-10744200-B2
Publication Date
2020-08-18
Expiration Date
Abstract
The present invention relates to an improved process for production of Aluminium phosphate (AlPhos) gel wherein the solutions of aluminium salt and alkaline phosphate salt are added to water by maintaining the pH under stirring to obtain the precipitate, followed by sterilization of the said precipitate and finally obtaining the Aluminum phosphate gel.
Core Innovation
The invention relates to a process for preparing an aluminum phosphate gel by admixing and stirring water and solutions of an aluminum salt and an alkaline phosphate salt at a pH between 3.0 and 4.0 to obtain the aluminum phosphate gel. The aluminum phosphate gel is characterized by particles with a size distribution of d(50) in a range of 3.0 μm to 9.0 μm and a mean particle size less than 7 μm.
After formation, the aluminum phosphate gel is sterilized by exposing the aluminum phosphate gel to a temperature in a range of 120-150° C. for a period of 30 to 90 minutes. The process is devoid of the steps of settling an aluminum phosphate suspension and removal of a supernatant.
The document further supports embodiments in which the process uses aluminum chloride and trisodium phosphate, includes controlled stirring and a pH maintained between 3.0 and 4.0, and provides additional particle-size distribution limits such as d(90). The supported context also describes producing sterile aluminum phosphate gel suitable for immediate antigen blending to form vaccine compositions.
Claims Coverage
The partial content provides two independent claims (clm-00001 and clm-00010). The inventive features focus on forming an aluminum phosphate gel by admixing and stirring at controlled acidic pH, sterilizing at specified temperature and time ranges, specifying particle size metrics, and excluding settling and supernatant removal.
Acidic admixing and stirring to form aluminum phosphate gel
Admixin g and stirring water and solutions of an aluminum salt and an alkaline phosphate salt at a pH between 3.0 and 4.0 to obtain the aluminum phosphate gel; wherein the aluminum phosphate gel has particles with a size distribution of d(50) in a range of 3.0 μm to 9.0 μm and a mean particle size less than 7 μm.
Sterilizing the aluminum phosphate gel at 120-150°C for 30-90 minutes
Sterilizing the aluminum phosphate gel by exposing the aluminum phosphate gel to a temperature in a range of 120-150° C. for a period of 30 to 90 minutes.
Devoid of settling and supernatant removal
The process is devoid of the steps of settling an aluminum phosphate suspension and removal of a supernatant.
Time-controlled admixing and stirring with aluminum chloride and trisodium phosphate
Admixing and stirring water and solutions of aluminum chloride and trisodium phosphate for 60 minutes, preferably between 35 to 55 minutes, to form the aluminum phosphate gel and maintaining a pH of the aluminum phosphate gel between 3.0 and 4.0, preferably between 3.2 and 3.5.
Across the two independent claims, the core coverage is the combination of gel formation at acidic pH with specified particle size metrics, sterilization at 120-150° C. for 30-90 minutes, and the exclusion of settling and supernatant removal. The second independent claim additionally requires time-controlled admixing and stirring using aluminum chloride and trisodium phosphate with a maintained pH window.
Stated Advantages
Scalable preparation of sterile aluminium phosphate (AlPhos) gel with controlled particle size metrics while being devoid of settling and supernatant removal.
Supports closed-system aseptic production and immediate antigen blending for vaccine formulation.
Provides comparative/consistency and stability characterization against commercial Adju-Phos (Brenntag) across scales (1 L–360 L) with physico-chemical parameters reported.
Documented Applications
Adsorbing one or more antigens onto an aluminum phosphate gel formed by the process to form a vaccine composition.
Formulating liquid pentavalent (LPV) vaccine compositions having LPV antigens including HBsAg, DT, TT, wP, and Hib conjugate using an aluminum phosphate gel without pH adjustment.
Formulating liquid quadrivalent (LQV) vaccine compositions having LQV antigens including DT, TT, wP, and Hib conjugate using an aluminum phosphate gel without pH adjustment.
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