Rapid, one-step process for encapsulation of biologics
There are a large percentage of new biologic drug prospects that have high aqueous solubility, but are susceptible to rapid clearance, preventing the development of suitable biologic formulations. Flash NanoPrecipitation (FNP) is a process which through rapid mixing stabilizes a compound of interest such as drugs into a nano-sized, polymer-stabilized delivery vehicle. Previously, FNP has been limited to the encapsulation of hydrophobic molecules (logP>6) based on hydrophobic interactions. However, extending FNP to encapsulating hydrophilic molecules such as biologics (i.e., proteins) would provide a rapid method to expand the clinical applications for biologic-based therapies. Others have also approached encapsulating biologics with FNP; however, they require multiple steps, which is in contrast to the process presented here.
Virginia Commonwealth University researchers have developed a rapid, single-step process using FNP to encapsulate biologics using a cationic polyelectrolyte and tannic acid (TA). The intermolecular interactions for forming the nanoparticles allows for high biologic loading, which increases the bioavailability. The benefit of increased bioavailability is a high delivery dosage. Such an approach would be used for protein therapies, cancer treatments, and diseases that require high specificity.
Encapsulation biologics process [View Image]
Figure 1: Diagram of a model system example encapsulating BSA, a model protein, using FNP with TA to form an anionic precipitate that is stabilized with a cationic polymer stabilizer (i.e., polyethylenimine or PEI). The mechanism of self-assembly is affected by the molecular weight of the PEI.
- One step process
- Increased stability > 1 week
- High biologics loading
- Protein therapies
- Cancer treatments
- Diseases with specificity:
- Heart disease
- Crohn's disease
- $10,000 conversion fee
- Royalty rate of 3% (2% for VA companies)
- For VA start-ups, royalty free for first $100,000 in sales; 2% thereafter
Christina Tang, Ph.D.
Patent Pending: U.S. and foreign rights available
This technology is available for licensing to industry for further development and commercialization
Engineering and physical science
VCU Tech #:
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Koffi Selom Egbeto, M.S.