Formulation Development Laboratory

ChoroPharma, LLC has completed the setup and establishment of their first formulation development lab in Research Triangle Park, NC. This milestone allows ChoroPharma to complete drug development studies for our complex ophthalmic products. This includes all required drug substance and drug product analytical characterization including assay and related substances, particle size distribution/zeta potential, and in-vitro release testing. The testing ability of the formulation development lab will allow prototype formulation development to be completed, including formulation optimization and stability assessment.

The first four (4) product development reports, per QbD, will be completed by the end of this year. The development will include:

• Reference list product (RLD) physiochemical characterization and stability assessment

• Drug substance and excipient selection and characterization

• Drug product formulation development and stability

• Manufacturing process development and proposed manufacturing recommendations

• Identification of Critical Process Parameters (CPP)