Nanofiltration of Liquid Factor VII Compositions
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Solution Overview
Problem
Existing methods for purifying and handling Factor VII compositions are inadequate in removing viruses while preserving the integrity of the Factor VII constituents, as they are susceptible to mechanical degradation and enzymatic activity, and current virus filtration methods are not effective for all types of viruses.
Innovation Solution
The use of nanofiltration with nanofilters having a pore size of at most 80 nm, specifically designed for liquid Factor VII compositions, including those with a significant ratio of activated Factor VII polypeptides, using membranes made from materials like cuprammonium regenerated cellulose or hydrophilic polyvinylidene fluoride, and the optional use of detergents for virus inactivation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional filtration methods are used to remove viruses from Factor VII compositions, then virus removal efficiency is improved, but mechanical degradation of Factor VII molecules occurs due to shear forces
Solution Approach 1:
The patent changes the critical parameter of pore size to 80 nm or larger, which is significantly larger than conventional virus filter pore sizes. This parameter change reduces mechanical shear forces on Factor VII molecules while still achieving effective virus removal through the optimized filtration system
Solution Approach 2:
The patent employs composite filtration systems combining nanofilter membranes with specific material properties (hydrophilic polyvinylidene fluoride or cuprammonium regenerated cellulose) that provide both effective virus removal and gentle handling of Factor VII, resolving the contradiction between filtration efficiency and molecule integrity
2Manufacturing precision
If Factor VII is purified and handled using conventional methods, then purification is achieved, but degradation occurs through mechanical shear forces and enzymatic activity
Solution Approach 1:
The patent applies preliminary protective measures by using gentle nanofiltration conditions and optimizing buffer compositions before degradation can occur. The method proactively prevents degradation rather than correcting it after the fact, maintaining composition stability throughout the purification process
Solution Approach 2:
The nanofilter membrane acts as an intermediary that separates viruses from Factor VII without requiring harsh chemical or mechanical treatments. This intermediary approach enables purification while protecting the delicate Factor VII structure from degradation
3Reliability
If nanofiltration with pore size of at most 80 nm is used to remove viruses, then virus clearance is improved, but the complexity of the filtration system increases
Solution Approach 1:
By standardizing the pore size parameter at 80 nm or larger, the patent simplifies system design and operation while maintaining high virus clearance. This parameter optimization balances effectiveness with operational simplicity, reducing overall system complexity
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
This method effectively removes both enveloped and non-enveloped viruses from Factor VII compositions, maintaining the integrity of the Factor VII constituents and achieving high-level virus clearance, suitable for large-scale production processes.
Implementation Method 1
subjecting said solution to nanofiltration using a nanofilter having a pore size of at the most 80 nm
Implementation Method 2
nanofilter having a pore size of at the most 80 nm
Implementation Method 3
the optional use of detergents for virus inactivation
Data Source
AI summary
The present invention relates to a novel method for improving the viral safety of liquid Factor VII compositions, in particular those comprising active Factor VII polypeptides (a Factor VIIa polypeptide).