Homogeneous Lipoprotein Complex Manufacturing by Controlled Hydration
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for producing lipoprotein complexes are inefficient, result in heterogeneous products, and require costly purification processes, leading to protein degradation and high production costs, limiting the therapeutic use of apolipoproteins like ApoA-I and ApoA-IM.
Innovation Solution
Development of new methods for producing homogeneous lipoprotein complexes with high purity, such as detergent dialysis and high-pressure homogenization, along with improved purification techniques to enhance yield and reduce contaminants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If current methods for producing lipoprotein complexes are used, then production can proceed with existing technology, but the products are heterogeneous and require costly purification processes leading to protein degradation
Solution Approach 1:
The patent applies parameter changes by controlling the molar ratio of apolipoprotein to phospholipid (specifically 1:75 to 1:125) and controlling the hydration process parameters to produce homogeneous lipoprotein complexes. This resolves the contradiction by achieving manufacturing precision through controlled parameter ranges while maintaining ease of manufacture through a streamlined process that eliminates costly purification steps.
2Manufacturing precision
If current production methods are used, then production can proceed with existing technology, but purification processes are costly and time-consuming
Solution Approach 1:
The patent applies preliminary action by pre-forming homogeneous lipoprotein complexes with controlled composition and size (8-15 nm diameter) before administration. This preliminary control of complex formation eliminates the need for subsequent costly and time-consuming purification processes, as the complexes are produced in a pure, homogeneous state ready for therapeutic use.
3Productivity
If current production methods are used, then production can proceed with existing technology, but protein degradation occurs reducing yield
Solution Approach 1:
The patent applies parameter changes by controlling the hydration process and maintaining specific molar ratios of apolipoprotein to phospholipid, which protects the apolipoprotein from degradation. This resolves the contradiction by improving reliability through controlled parameters that prevent protein degradation, thereby increasing productivity through higher yield of stable, functional apolipoprotein complexes.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
These methods enable more economical large-scale production of uniform and pure lipoprotein complexes, reducing the risk of side effects and lowering the cost of therapeutic administration.
Implementation Method 1
Development of new methods for producing homogeneous lipoprotein complexes with high purity, such as detergent dialysis
Implementation Method 2
high-pressure homogenization, along with improved purification techniques to enhance yield and reduce contaminants
Data Source
AI summary
The present disclosure relates to lipoprotein complexes and lipoprotein populations and their use in the treatment and/or prevention of dyslipidemic diseases, disorders, and/or conditions. The disclosure further relates to recombinant expression of apolipoproteins, purification of apolipoproteins, and production of lipoprotein complexes using thermal cycling-based methods.