CRITICAL INNOVATIONS LLC — Department of Defense SBIR Phase II: DHA201-D001
CRITICAL INNOVATIONS LLC — SBIR Phase II award from Department of Defense.
- Amount
- $1,650,000
- Agency
- Department of Defense · Defense Health Program
- Program / Phase
- SBIR · Phase II
- Topic
- DHA201-D001
- NAICS
- —
- Place of performance
- CA
- Period
- 2022-09-21 → 2024-01-21
Description
Under this aim, the team will perform a series of tests to verify appropriate concentrations and potency of the selected antibiotics in the Succor™ product. These tests will demonstrate that the appropriate antibiotics are in the product, at the appropriate concentrations, and function as expected. Testing will be performed in accordance with FDA guidance and feedback, as applicable. Example tests include raw material testing (e.g. confirming raw antibiotics meet the required specifications), concentration confirmation testing (e.g. confirming the concentration or activity is correct in the final product), and activity testing (e.g. confirming that the end product has the appropriate potency). These tests may be performed at various steps through the manufacture process, as well as on aged specimens. All testing will follow and be compliant with Critical Innovations’ ISO 13485-certified design control system. The final product of this aim will be antibiotic verification and related testing results for use in further regulatory and development activities.