Monolithic Anion Exchanger for PCC Purification
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Solution Overview
Problem
Current methods for purifying Prothrombin Complex Concentrate (PCC) and Factor IX from plasma require multiple dilution steps, leading to loss of activity of physiologically active proteins and are inefficient.
Innovation Solution
The process employs sample displacement chromatography with a monolithic anion exchanger as the initial purification step, followed by additional chromatography steps using anion and cation exchangers, allowing for the purification of PCC and FIX from undiluted cryo-poor plasma, which maintains protein activity and reduces the need for multiple dilutions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If multiple dilution steps are used in current purification methods, then the purification process can be completed, but loss of activity of physiologically active proteins occurs
Solution Approach 1:
The invention changes the concentration parameter by using undiluted or minimally diluted plasma as feedstock, reversing the conventional approach of multiple dilutions. This parameter change maintains protein activity while achieving purification through the chromatographic process designed for concentrated samples
Solution Approach 2:
The invention extracts and removes impurities directly from undiluted plasma through chromatography, rather than relying on dilution to reduce impurity concentration. The chromatographic system is designed to selectively bind and separate target proteins from the complex plasma matrix at high concentration
2Manufacturing precision
If multiple dilution steps are performed, then purification can proceed, but the process becomes inefficient
Solution Approach 1:
The invention performs preliminary concentration and pre-purification steps before the main chromatographic separation, allowing the subsequent steps to work with optimized sample characteristics. This preliminary action eliminates the need for multiple dilution cycles and accelerates the overall process
Solution Approach 2:
The invention implements a continuous chromatographic process where undiluted plasma flows through the system without interruption for dilution and re-concentration cycles. The useful action of purification continues uninterrupted, maintaining high productivity while achieving the required purification level
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 purifies PCC and FIX with higher specific activity and balances vitamin K-dependent clotting factors and inhibitors, reducing the loss of active proteins and improving the efficiency of the purification process.
Implementation Method 1
chromatography using a monolithic stationary phase, the method comprising a) performing of an initial sample displacement chromatography step of complete plasma or cryo-poor plasma on an anion exchanger to obtain a first fraction enriched in PCC
Implementation Method 2
the chromatography step is performed with an anion exchanger to obtain a second fraction enriched in PCC
Data Source
AI summary
A process for the purification of Prothrombin Complex Concentrate (PCC) from complete plasma or cryo-poor plasma, in particular undiluted cryo-poor plasma, by means of chromatography using a monolithic stationary phase, the method comprising performing an initial sample displacement chromatography step of complete plasma or cryo-poor plasma on an anion exchanger to obtain a first fraction enriched in PCC.