Purified plasmodium and vaccine compositions
Inventors
Sim, B. Kim Lee • Li, Minglin • Stafford, Richard E. • Hoffman, Stephen L.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-8367810-B2
Publication Date
2013-02-05
Expiration Date
Abstract
Disclosed are substantially purified Plasmodium sporozoites and preparations of Plasmodium sporozoites substantially separated from attendant non-sporozoite material, where the preparations of Plasmodium sporozoites have increasing levels of purity. Vaccines and pharmaceutical compositions comprising purified Plasmodium sporozoites are likewise provided. Methods of purifying preparations of Plasmodium sporozoites are also provided.
Core Innovation
A substantially purified, live metabolically active Plasmodium sporozoite preparation is provided as a vaccine and pharmaceutical composition. The preparation comprises Plasmodium sporozoites and is substantially free of attendant non-sporozoite material, including mosquito salivary gland material, and is described as suitable for formulation and use as live sporozoite products.
The purification method produces a purified sporozoite preparation by filtering an aqueous pre-purification preparation comprising sporozoites and attendant non-sporozoite material. The method sequentially passes the sporozoite preparation through a set of size exclusion filters, followed by dead end filtration to collect substantially purified sporozoites.
The filtration scheme includes exclusion matrix filters and a third membrane filter with pore-size relationships that allow passage of sporozoites while retaining attendant material across size ranges. The resulting purified sporozoite preparation is live and metabolically active, and may be attenuated or pathogenic depending on the intended use context.
Vaccine use is described for prevention of malaria and for use as challenge/assay tools. The disclosure includes biological and analytical concepts for potency and product quality, including quantification approaches related to salivary gland material and assay approaches based on hepatocyte-associated readouts.
Claims Coverage
The document identifies one independent claim describing a filtration-based purification method, with dependent claims adding impurity limits and product-quality constraints.
Sequential size-exclusion filtration and dead end collection for substantially purified sporozoites
A method for purification of a species of metabolically active Plasmodium sporozoites that causes human disease, comprising providing an aqueous pre-purification preparation comprising sporozoites and attendant non-sporozoite material, sequentially passing the preparation through a set of size exclusion filters with defined pore-size retention and passage relationships, collecting substantially purified sporozoites by dead end filtration on a collecting filter with a pore size capable of retaining the sporozoites, and removing the collected substantially purified sporozoites from the collecting filter thereby producing a purified sporozoite preparation that is substantially free of attendant non-sporozoite material.
Overall claim coverage centers on producing a substantially purified, metabolically active Plasmodium sporozoite preparation by sequential size exclusion and dead end filtration to remove attendant non-sporozoite material.
Stated Advantages
Produces a purified sporozoite preparation that is substantially free of attendant non-sporozoite material.
Enables vaccine and pharmaceutical compositions comprising substantially purified, live metabolically active Plasmodium sporozoites.
Allows quantitative reduction/removal of mosquito salivary gland material normalized to sporozoite amount.
Documented Applications
Prevention of malaria using vaccine compositions comprising substantially purified, live Plasmodium sporozoites.
Use of the live sporozoite compositions as challenge/assay tools, including assays based on hepatocyte readouts.
Interested in licensing this patent?