1. Precision Uniformity via Stir-free Microsphere Formation
Replacing mechanical stirring with microporous membrane regulated extrusion and in-line sedimentation-aided curing, this process eliminates harsh shear emulsification. The result is exceptional particle uniformity and minimized drug leakage, preserving the integrity of sensitive payloads.
2. Seamless Scalability: From Years to Weeks
Our unique "constant-parameter" design revolutionizes scale-up. Key factors¡ªmembrane pore size, spacing, and settling distance¡ªremain identical from lab to manufacturing scale. By simply increasing membrane count and column diameter, we achieve linear scale-up, reducing process development time from years to mere weeks.
3. Compact Design for Grade A Integration
Enabled by our streamlined continuous process, the minimized equipment footprint fits seamlessly into Grade A isolation environments. This facilitates fully enclosed, sterile operations that meet the highest regulatory standards for injectable manufacturing.
4. Eco-Friendly Close-loop Solvent Recycling
We replace the conventional solvent distillation curing with a water extraction process in the microsphere washing step. This decouples microsphere solidification from solvent recovery, eliminating the need for massive exhaust treatment system. The solvent in the washing liquid is recycled in a compact, close-loop module and reused within the main production line.
5. Protein Stabilization via Polysaccharide Pre-encapsulation
We employ an aqueous-aqueous emulsion-aided pre-formulation strategy to load proteins into the matrix of polysaccharide particles that preserve the natural conformation of protein drugs during microsphere production. This approach effectively prevents denaturation and mitigates immunogenicity risks.
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