Lactase Salt Formulation for Sterile Filterability

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Solution Overview

Problem

Commercial lactase preparations, often containing stabilizing agents like glycerol, are difficult to process through sterile filters due to their viscosity, necessitating improved formulations for easier filtration.

Innovation Solution

Adding monovalent or divalent cations, such as salts like NaCl or KCl, to lactase preparations at concentrations of at least 0.01% w/w enhances their filterability through sterile filters, particularly those with 0.22 μm pore sizes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If glycerol is added to lactase preparation for stabilization, then enzymatic stability is improved, but viscosity increases making filtration difficult

Engineering Contradiction:
Improveenzymatic stabilityVSAvoidfiltration ease
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The invention changes the chemical composition parameters by adding monovalent or divalent cations (such as Na+, K+, Ca2+, Mg2+) to the lactase preparation. These cations modify the physical properties of the solution, specifically reducing viscosity and improving filterability while maintaining the stabilizing effect of glycerol. The cation addition allows the preparation to flow more easily through sterile filters without compromising enzymatic stability.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If high concentration of lactase is used to reduce storage time, then productivity is improved, but viscosity increases making sterile filtration difficult

Engineering Contradiction:
Improvestorage time reductionVSAvoidsterile filtration ease
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The invention modifies the physical-chemical parameters of high-concentration lactase preparations by adding monovalent or divalent cations. This addition reduces the viscosity associated with high enzyme concentrations, enabling efficient sterile filtration even when lactase is present at high levels. The cations act as viscosity modifiers that maintain high productivity while facilitating the sterile filtration process.

Inventive Principle:
Principle #35Parameter changes

3Object-generated harmful factors

If pre-filters with larger pore size are used, then large particles are retained, but sterility is not achieved

Engineering Contradiction:
Improvelarge particle removalVSAvoidsterility assurance
Core Design Contradiction:
Object-generated harmful factorsVSReliability

Solution Approach 1:

The invention implements a two-stage filtration system that segments the filtration function into two distinct stages: (1) pre-filtration using filters with larger pore sizes to remove large particles and aggregates, and (2) sterile filtration using filters with 0.22 μm pore sizes to ensure sterility. This segmentation allows each filter stage to be optimized for its specific function, with pre-filters handling bulk particle removal and sterile filters providing microbial containment.

Inventive Principle:
Principle #1Segmentation

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

The addition of salts improves the ability of lactase preparations to be filtered sterilely, allowing for more efficient processing and maintaining enzymatic stability.

Implementation Method 1

adding salt to a liquid lactase preparation improves its ability to be passed through a sterile filter

Methodology Applied
Scientific EffectViscosity reduction:

Implementation Method 2

Sterile filtration of the lactase solution is achieved by pumping the enzyme concentrate through a at least one filter with an absolute pore size of 0.22 μm, and that will retain particles such as fungi, bacteria, spores still present in the solution

Methodology Applied
Scientific EffectPhysical filtration: Filter (physical)

Data Source

PatentUS12419318B2Sterile filtered lactase preparation comprising salt with monovalent cation
Publication Date: 2025.09.23 KERRY GRP SERVICES INT LTD

AI summary

The present invention relates to a sterile-filtered liquid lactase preparation and to a method of sterile filtering a liquid lactase preparation.