IRISYS, LLC Manufacturing Clinical Trial ACT-1 Ophthalmic Solution For Corneal Healing

IRISYS, LLC entered a contractual relationship in 2013 with Leidos Biomedical Research, Inc. Leidos Biomedical is the operations and technical support contractor for the Frederick National Laboratory for Cancer Research and is affiliated with the NCATS Bridging Interventional Development Gaps (BrIDGs) Program. NCI is collaborating with an early-stage biotech company to advance ACT-1 peptide towards clinic trials.IRISYS was asked to develop and manufacture for human clinical trials a sterile ophthalmic solution containing the ACT-1 peptide for an ocular indication. ACT-1 has shown promising preclinical efficacy in relation to corneal healing. ACT-1 is designed to enter the cell and competitively inhibit the binding of connexin43 (Cx43).

The formulation IRISYS developed is free of preservatives (a unique attribute for a multi-dose ophthalmic dosage form). Microbiological safety is conferred by the eyedropper pumps which are developed by AEROPUMP, a German company specializing in pump systems for pharmaceutical applications.

The unique design of the eyedropper pump allows multidose delivery. IRISYS will use its technical expertise and state of the art facility to scale, manufacture, fill and seal sterile isotonic ophthalmic solution containing ACT-1 in eye dropper vials under cGMP conditions and initiate clinical stability for two years. The project started in December 2019. AS called for in the project scope, IRISYS will:

  1. Provide full analytical support for development and batch release;

  2. Provide full clinical development support including optimizing processing parameters for clinical manufacturing and scale-up, filling and sealing in a Class 100 aseptic suite;

  3. Batch release by Quality control and Quality Assurance;

  4. Clinical stability studies for two years as per ICH guidelines;

  5. Maintaining documentation for the CMC section of the IND application.

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