Therapeutic Biologic Particle Morphology Control
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Solution Overview
Problem
Current methods for forming circular particles with therapeutic biologics face challenges in achieving sufficient control over size uniformity, shape selectivity, and skeletal density, leading to difficulties in producing particles with low internal void spaces.
Innovation Solution
A method involving the formation of droplets by contacting a liquid containing a therapeutic biologic with a solvent and a third liquid, followed by drying, to produce particles with less than 10% internal void spaces and circularity ranging from 0.80 to 1.00, utilizing techniques such as impinging jet mixers and membrane emulsification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional particle formation methods are used, then particles can be produced, but size uniformity and shape selectivity are insufficient
Solution Approach 1:
The particle formation process is segmented into distinct stages: droplet generation in a first continuous phase, followed by transfer to a second continuous phase for drying. This segmentation allows independent optimization of each stage for size uniformity and shape control.
Solution Approach 2:
A first continuous phase acts as an intermediary medium to generate monodisperse droplets before transfer to the second continuous phase. This intermediary step enables precise control over droplet size and uniformity that cannot be achieved directly in the final particle formation medium.
2Manufacturing precision
If conventional particle formation methods are used, then particles can be produced, but internal void spaces are high
Solution Approach 1:
The drying process occurs continuously as droplets are transferred from the first continuous phase to the second continuous phase, eliminating the need for separate drying equipment and reducing internal void spaces through controlled evaporation.
Solution Approach 2:
The method utilizes fluid dynamic principles in the impinging jet mixer to generate monodisperse droplets with controlled morphology, and the continuous phase system provides a hydraulic environment for uniform drying that minimizes internal void formation.
3Shape
If non-circular microparticle synthesis is used, then physical properties are enhanced, but control over shape selectivity is difficult
Solution Approach 1:
The method controls particle shape by adjusting parameters including the ratio of continuous to dispersed phase, flow rates, and composition of continuous phases. These parameter changes enable precise control over droplet and final particle morphology.
Solution Approach 2:
The method inherently produces circular or spherical particles through droplet formation in the first continuous phase, maintaining shape uniformity while allowing controlled deviations from perfect sphericity through parameter adjustment for specific application requirements.
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 enables the controlled formation of circular particles with low internal void spaces, enhancing the stability and pharmaceutical applications of therapeutic biologics, such as antibodies and proteins, by improving their physical properties and retention of biological activity.
Implementation Method 1
contacting the liquid droplets with a third liquid, thereby allowing the liquid droplets to dry
Data Source
AI summary
The present disclosure relates to compositions and methods that enable the formation of pharmaceutically relevant particles that can be used for therapy. In particular, the methods disclosed herein allow the controlled formation of circular particles having low internal void spaces comprising bioactive therapeutic biologies.