Phase II Amount
$1,491,568
Sterility testing of biologics products remains a regulatory requirement in the pharmaceutical industry. However, currently available technologies and instrument suffer tedious labor interventions on culturing, staining or filtering procedures that preclude a rapid and automated testing. In this SBIR program Zymeron will develop a revolutionary micro Sterility Test Filtering (µSTF) instrument for rapid and automated sterility testing of biologics collected directly from manufacturing lines. The µSTF can be automatically operated with only sample loading required by an operator. The proposed method eliminates time-consuming culturing and staining steps. Instead, it utilizes novel Lab-on-Chip technologies for microorganism capture, detection, and identification. µSTF features low sample volume input, high-degree automation, and fast analysis from sample in to result out in less than 20-30 minutes. The innovation will be a technology breakthrough for sterility testing compared to the currently available methods in providing outstanding performances in testing speed and sensitivity. The proof of concept with beta prototype was demonstrated with 2 different contaminants showing nearly 100% sensitivity and specificity. In the Phase II, Zymeron will conduct a series of qualification and validation of the instrument, the method, the suitability, the quality control, and the software package with end users in operational environment. A scalable automated production process will be developed ready for adoption in manufacture lines.
