Protein Qspec: An Improved Method for Rapid Characterization of Protein Aggregates in Biologic Drugs for Increased Quality and Safety

Optofluidics will develop Protein Qspec, a new particle analysis QC instrument designed to characterize protein aggregates in biologic drugs. The primary concern for this class of therapeutics is that they can elicit an immune response from patients who develop anti-drug antibodies which can eliminate the therapeutic benefit. The presence of particulate matter, in these therapeutics (e.g. shed glass from a syringe or a protein aggregate) enhances this immune response and the FDA therefore regulates the amount of particles that can be present. Although these particles can be counted scientists rarely know what the particles actually are due to lack of effective analysis equipment. The proposed Qspec will fill this need by rapidly capturing particles on a microfabricated sieve followed by rapid FTIR microscopy. Early proof of concept work shows analysis to be about an order of magnitude faster than existing forensic instruments. A QA/QC tool that can identity particles and, if they’re proteins, thoroughly characterize them with spectroscopy, would help pharma companies make better decisions to make stable and safe formulations of biologic drugs as well as detect problems earlier on and forestall manufacturing or safety issues.