Imprex Stabilization

Understanding the commercial vulnerabilities of unstable drug targets, NanoSpheRx secured its proprietary sub-zero Imprex SFL Stabilization technology. The Imprex SFL Stabilization Process allows promising biopharmaceutical drug targets with unstable profiles the opportunity to make it to market.

The Imprex SFL Stabilization Process maximizes preservation of active ingredients while minimizing degradation (monomer loss) and aggregation (insoluble aggregates). Imprex SFL out-performs standard lypholization by substantially reducing aggregation, degradation, and processing losses thus increasing manufacturing profitability and regulatory compliance. Imprex SFL has been shown to reduce raw material processing losses by as much as 70%, depending on active ingredient profiles.

Virtually every biotech lab in America has a lyophilizer. Until recently, lyophilization (freeze drying) was considered standard operating procedure for creating dry powders.

Then came Spray Freeze Drying (SFD) and Super Critical Fluid processing, both pre-lyophilization steps that rapidly froze the biopharma drugs. However, unforeseen uncontrollable variables with these techniques began compromising the stability and bioactivity of biomolecules. Simply stated, both SFD and SCF were too violent for delicate biomolecules. Expensive raw materials were lost.

Imprex SFL has controlled for these variables, advancing the state-of-the-art. Imprex SFL effectively replaces independent lyophilization, SFD, and SCF in the biopharmaceutical market due to Imprex's distinct advantages.

In peer-review published research, Imprex SFL has been shown to preserve the structure of proteins and peptides better than any other published method. Until now, protein research was flawed, due to the fact that as much as 30% of protein processed using competitive techniques was lost to aggregation and degradation.

And since the FDA is becoming concerned about the long-term health implications of aggregated proteins, biopharma is going to have to address the downfalls of standard lyophilization, SFD and SCF head-on. Imprex SFL gives them a cost-effective immediately available solution.

"Imprexing" generates high surface area, porous nanoparticles that can be incorporated into a variety of formulations, including our Imprex Microspheres. Imprex Microspheres can be easily incorporated into a variety of delivery formats including pulmonary inhalers, injectables (e.g. depot release, subcutaneous, I.M.), and oral dosage forms.