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EasySphere and EasySphere+
Our microsphere technology (EasySphere) comprises a production process and related equipment that produce microspheres of uniform size and +95% encapsulation efficiency in a water-based medium, and a sterilized environment. The production process of EasySphere is designed in a way that each unit operation can accomplish 2~3 tasks, so that the entire process consists only two unit operations. This simplified engineering does not only avoid the conflicts between unit operations of conventional microencapsulation (such as using silicone oil to improve encapsulation efficiency results in complicated equipment for environment and safety management), but also enables the entire process to be incorporated in a portable sterile hood for small-scale manufacture. Our EasyPhere+ adds a protein pre-formulation step to EasySpehre and enables fragile proteins be encapsulated in the microspheres for sustained-release injection without denaturing and evoking antibodies. The microspheres ensure a steady release profile for proteins and peptides (such as native EPO and exenatide) over weeks and a month. A portable aseptic system designed by our R&D team for pilot production and supplying monthly-dosing exenatide microspheres to 100K patients is currently under trial production.
Phase-transition microneedle patch
Previously reported microneedle systems encountered essential difficulties. For example, inorganic solid micro needles lack the capacity to load drugs; hollow micro needles easily break and block when applied to the skin; dissolvable microneedles deposit the needle tip materials to the skin; and the so-called hydrogel-forming microneedles rely on covalent cross-linking to prevent polymer dissolution in the epidermis for which proteins may not be loaded in the needle tip matrix to avoid being exposed to chemical reactions. Using swelling-activated release mechanism and a non-reactive microcrystalline cross-linking, our phase-transition microneedle (PTM) patch is able to overcome the above-mentioned difficulties at once, and achieve efficient, accurate and safe transdermal delivery of proteins, peptides and other lipophobic medicines. The PTM patch can be removed from the application site completely after drug administration without leaving the needle tip materials in the skin, a favorable property for transdermal delivery of medicines that require multiple doses per day for long period of time such as insulin. Based on the unique mold which is permeable to air but impermeable to water, a pilot production system to produce PTM patches for clinic trials has been established.
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