CSL has been granted a patent for a reconstituted high density lipoprotein (rHDL) formulation with reduced renal toxicity and enhanced stability. The formulation includes apolipoprotein, lipid, and lyophilization stabilizer in specific ratios. This innovation is particularly beneficial in lyophilized form. GlobalData’s report on CSL gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on CSL, Personalized cancer vaccines was a key innovation area identified from patents. CSL's grant share as of May 2024 was 47%. Grant share is based on the ratio of number of grants to total number of patents.
Formulation for reconstituted high density lipoprotein with lyophilization stabilizer
A recently granted patent (Publication Number: US11957731B2) discloses a reconstituted high density lipoprotein (rHDL) formulation that includes an apolipoprotein, a lipid, and a lyophilization stabilizer. The ratio between the apolipoprotein and the lipid in the formulation ranges from about 1:45 to about 1:65 (mol:mol), with the total concentration of all lyophilization stabilizers falling between 1.0% to less than 6.0% (w/w of the rHDL formulation). The lyophilization stabilizer can be a sugar, sugar alcohol, amino acid, or a combination thereof, with specific concentrations and ratios outlined in the patent claims.
Furthermore, the patent details the inclusion of a detergent, such as sodium cholate, in the rHDL formulation, along with specific concentrations of the apolipoprotein (5 to 50 mg/ml) and lipid (phosphatidylcholine). The apolipoprotein can be Apo A-I or a fragment thereof, while the lipid can be a mixture of sphingomyelin and phosphatidylglycerol. The lyophilization stabilizer can be a combination of sucrose and mannitol. The patent also covers the lyophilization of the rHDL formulation and the production of vials containing the lyophilized product, with varying protein content per vial. Additionally, a method for producing the rHDL formulation and a method for treating diseases in humans by administering the rHDL formulation are disclosed in the patent claims.
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