Assessing Device Compatibility Through Assay Matrix Approach Ensures Therapeutic Consistency, Patient Welfare

By R. Dhambri, H. Naas, M. Sawyer, C. Salas, C. Jerome, G. Iyer, and S. Sleep

This study evaluated the impact of subretinal injection device exposure time on the drug product, a critical factor for clinical trial safety and efficacy. Drug product samples were prepared at potential low and high dosages according to the investigator's brochure protocol and subjected to extended exposure durations exceeding clinical expectations. Triplicate samples were exposed to the sterile syringe and injection needle for 6 hours at ambient temperature or 30 minutes in cold storage, while control samples underwent identical preparation without exposure to the device.

Comprehensive assays assessed vector concentration, infectivity, expression, and potency to identify potential effects on therapeutic safety and efficacy. Results demonstrated no significant differences between exposed and non-exposed samples, with observed variations falling within assay precision margins, confirming consistency and reliability. These findings were consistent across both low and high dosage samples.