Quality-by-Design Approach to Process Intensification of Bioinspired Silica Synthesis.

Area of Science:

• * Nanomaterial Science
• * Chemical Engineering
• * Materials Science

Background:

• * Characterizing nanomaterials is complex due to their macromolecular nature, unlike small molecules or bulk crystalline materials.
• * Traditional methods like NMR and XRD are insufficient for comprehensive nanomaterial fingerprinting.
• * Synthesis and scale-up of nanomaterials present significant challenges compared to conventional materials.

Purpose of the Study:

• * To address the challenges in scaling up bioinspired silica nanomaterial synthesis.
• * To demonstrate the utility of a quality-by-design (QbD) approach for nanomaterial synthesis scale-up and intensification.
• * To adapt bioinspired silica synthesis for compatibility with existing manufacturing methods.

Main Methods:

• * Implemented a three-step quality-by-design (QbD) approach.
• * Identified critical quality attributes (CQAs) such as surface area, pore-size distribution, and reaction yield.
• * Determined critical process parameters (CPPs) by exploring process routes, reagents, and ratios, establishing acceptable limits for CQAs.

Main Results:

• * Increased specific yield from approximately 1.1 g/L to 38 g/L.
• * Reduced additive intensity from approximately 1 g/g product to 0.04 g/g product.
• * Significantly decreased synthesis cost and waste production through process intensification.

Conclusions:

• * The QbD approach effectively enables scale-up and intensification of bioinspired silica nanomaterial synthesis.
• * Mapping CPP effects on material formation pathways and CQAs is crucial for accelerated scale-up.
• * This methodology facilitates the transition of nanomaterials from laboratory research to market production.