H2Optx Inc — Department of Health and Human Services SBIR Phase I: FDA

Description

PROJECT SUMMARY Continuous manufacturing CM is attracting increasing attention within the pharmaceutical industry today because it could lead to significant decreases in production costs while improving product quality The shift towards continuous manufacturing processes increases the number of required measurements While batch processing utilizes a hold and test approach continuous manufacturing requires consistent testing at many steps This continuous testing approach requires complex machine interfaces to sample the product In addition the shift towards biologics based drug formulations has dramatically increased the complexity and frequency of measurements required during manufacturing The complexity and risks associated with biologics increases the number of testing steps to as compared to steps for small molecules As a result new innovative instruments are needed to meet the demands of current pharmaceutical manufacturing Randamp D and quality control H Optx Inc proposes to develop a new automated multiplexed hyperspectral imager based scanner analyzer that tie pharmaceutical manufacturing parameters to observed structures in powders and tablets The contribution of the proposed research is expected to be that by developing the scanner analyzer would significantly contribute to the current pharmaceutical manufacturing needs allowing to enhance process reliability and flexibility drug quality monitoring and speeding up the drug Randamp D efforts PROJECT NARRATIVE As a result of the shift towards continuous manufacturing processes and towards biologics based drug formulations new innovative instruments are needed to meet the demands of current pharmaceutical manufacturing Randamp D and quality control The contribution of the proposed research is expected to be that by developing the scanner analyzer would significantly contribute to the current pharmaceutical manufacturing needs allowing to enhance process reliability and flexibility drug quality monitoring and speeding up the drug Randamp D efforts The proposed scanner analyzer would be a new automated multiplexed hyperspectral imager based system with unsurpassed sensitivity speed and analysis capabilities