OPTOFLUIDICS, INC. — Department of Health and Human Services SBIR Phase II: FDA

Description

Abstract Optofluidics Inc proposes to develop FlowID a particle analysis quality control method designed to identify unwanted particles in therapeutic proteins that are injected directly into patients Protein therapeutics currently represent between and of the overall pharmaceutical market The primary concern for this class of therapeutics is that they can elicit an immune response from patients who develop anti drug antibodies The drug s effect is therefore eliminated between and percent of patients who return to their original disease state The presence of particulate matter in these therapeutics e g shed glass from a syringe or a protein aggregate can enhance this immune response and due to the patient safety risk the FDA regulates the amount of particles that can be present There are always some number of particles in each injected sample and although their presence can be detected they don t know what the particles actually are A QC tool that can identity the particles would help manufactures trace them back to their source e g a bad lot of syringes and eliminate them The proposed FlowID technology will provide high throughput particle identification that is an order of magnitude faster than the existing systems In addition it will provide particle counting information on par with state of the art instrumentation The heart of the innovation is in novel flow cell chips with a lithographically defined grid of micropores It uses a combination of automated microscope imaging with FTIR spectroscopy to quantitatively count size and identify each particle It will be an order of magnitude faster than the state of the art and completely automated We believe that the additional typing capability of a routine particle counting instrument will speed up clinical development and enable higher quality safer therapeutics At the conclusion of this Phase II effort we will have developed a beta instrument and consumables and conducted testing on site at GSK Narrative In this work Optofluidics will develop a new quality control instrument that can rapidly identify the presence of unwanted particulates in pharmaceutical injectable drugs The presence of these particles contributes to a side effect where patient s bodies reject the drug This returns them to their original diseased state and is a serious health risk and an obstacle in the development of these therapeutics A successful project will contribute to the health and safety of patients receiving these medications