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Our goal is to apply best-in-class formulation and delivery technologies to produce biopharmaceutics that are cost-effective in ready-to-use formats, i.e. no diluent, no mixing and no needles.
A barrier that must be overcome to achieving this goal is creating sufficiently stable dosage forms that not only simplify storage & handling requirements at points of use, but also can withstand potentially harsh processing conditions involved in their conversion to simpler delivery formats. Aridis’ macromolecular stabilization technology uses small molecular weight, FDA approved stabilizers (called plasticizers) to dynamically suppress high frequency molecular vibrations induced by the drug’s formulation environment. Our technology can convert proteins or complex vaccines that require refrigerators or freezers for storage and distribution into ambient temperature (25°C) stable products with shelf life that is measured in years.
Aridis’ solution will transform the administration of biopharmaceuticals from a labor-intensive procedure to one that can be as simple to handle and administer as a foil wrapped quick-dissolving oral wafer or inhaled powder. This means patients who require chronic therapeutics will have the added benefits of convenience, time-savings and less disruption to their daily activities. These technological advances can also make biopharmaceuticals more convenient and less costly for healthcare providers. Typically, handling and administration of biopharmaceuticals require skilled workers (pharmacist, physician and nurse) at significant cost, which can account for up to 40% of total administration costs for vaccines. By reducing the labor required, Aridis offers a strong purchasing incentive to healthcare providers at a time of rising concern over healthcare costs. Worldwide, large organizational purchasers (WHO, UNICEF, government agencies) and a less reliable cold chain make the need for fail-safe and less expensive biopharmaceuticals even more acute.
Our Pseudomonas mAb will be produced as room temperature stable, spray dried powders with the aerosol properties amendable for direct inhalation using cost effective commercially available dry powder inhalers. Our rotavirus vaccine will be produced as a room temperature stable quick dissolving wafer for convenient delivery to the oral mucosa.
Aridis’ stabilization approach combines advanced formulations employing sugar-based excipients with small molecular weight plasticizers and thermally mild drying processes that has stabilized many thermally labile proteins and vaccines [1,3,5,29] to generate a stable dosage form. Our stabilization technologies include:
1) An advanced stabilization approach which dramatically extends the stabilization potential of sugar glasses called ‘plasticization stabilization’. This technology uses FDA approved plasticizers such as glycerol, DMSO, etc. to suppress damaging high frequency vibrational motions that excipients matrix and protein side chains undergo even under normal storage conditions. This technology is compatible with most drying methods
2) Processing methods to gently convert biopharmaceutical formulations to dry state without compromising the bioactivity of the drug substance.
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