Mock Virus Particle Quantification for In-House Viral Clearance
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing methods for validating viral clearance in biopharmaceutical manufacturing are expensive and logistically difficult, requiring third-party labs for infectivity assays, which prolongs the development of purification processes and increases regulatory risk.
Innovation Solution
A method involving the use of Mock Virus Particles (MVP), which are non-infectious, synthetically produced viral capsid or envelope proteins, to quantify virus removal efficiency through techniques like ELISA, PCR, and microscopy, allowing in-house validation of purification processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If infectivity assays (TCID50 or Q-PCR) are used to quantify virus removal, then measurement precision is improved, but device complexity and loss of time increase due to requiring third-party labs and additional safety measures
Solution Approach 1:
The patent creates a simplified copy of the virus structure (mock virus particles consisting of capsid proteins) that retains the physical properties needed for purification validation but eliminates the complex biological functions. This allows quantification through simpler ELISA or particle counting methods rather than requiring complex infectivity assays
Solution Approach 2:
The patent uses mock virus particles that are non-infectious and can be easily produced and disposed of, replacing expensive and complex live virus systems. These particles enable routine in-house testing without the need for specialized third-party laboratories
2Measurement precision
If infectivity assays are performed in third-party labs, then measurement precision is improved, but loss of time increases due to logistical difficulties and extended development timelines
Solution Approach 1:
The patent enables biopharmaceutical companies to perform their own virus removal validation using mock virus particles and simple quantification methods (ELISA, particle counting). This self-service capability eliminates the need to outsource to third-party laboratories, allowing rapid in-house optimization of purification processes during development
3Measurement precision
If live virus is used for validation studies, then measurement precision is improved, but object-generated harmful factors increase due to safety risks and regulatory requirements
Solution Approach 1:
The patent takes the harmful aspect of live virus (infectivity) and converts it into a benefit by creating mock virus particles that physically resemble virus but lack biological function. This allows the particles to be used for validation without posing safety risks, eliminating the need for biosafety containment while maintaining measurement capability
Solution Approach 2:
The patent uses non-infectious mock virus particles that can be safely handled without special biosafety measures. These particles eliminate the harmful factors associated with live virus while enabling routine validation studies in standard laboratory conditions
Data Source
AI summary
The present invention relates to a method of quantifying the amount of Mock Virus Particles (MVP) removed from a solution as a result of processing that solution through a purification technique. This method involves the steps of adding MVP to a solution, processing the solution through a purification technique, quantifying the amount of MVP removed from the solution. The present invention also relates to a kit that can be used in conjunction with the method. This kit will comprise at least one stock solution of MVP and at least one quantification solution.