SBIR-STTR Award

Horizon: Validation of an Improved Method for Rapid Characterization of Protein Aggregates in Biologic Drugs for Increased Quality and Safety
Award last edited on: 1/16/2018

Sponsored Program
SBIR
Awarding Agency
DOC : NIST
Total Award Amount
$399,980
Award Phase
2
Solicitation Topic Code
9.02.01
Principal Investigator
Robert W Hart

Company Information

Halo Labs (AKA: Optofluidics Inc)

3711 Market Street Suite 970
Philadelphia, PA 19104
   (215) 253-5777
   info@opfluid.com
   www.opfluid.com
Location: Single
Congr. District: 03
County: Philadelphia

Phase I

Contract Number: ----------
Start Date: ----    Completed: ----
Phase I year
2016
Phase I Amount
$99,993
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.

Phase II

Contract Number: ----------
Start Date: ----    Completed: ----
Phase II year
2017
Phase II Amount
$299,987
Optofluidics and the University of Delaware propose to complete the development of the Horizon technology and carry out validation via a comprehensive multi-site study. The technology is a subvisible particle analyzer pioneered during Phase I. The technology is designed to fill two critical gaps in biopharmaceutical product development: (1) Scientists can count and image particles with current tools, but they cannot easily identify them which hampers their ability to minimize or eliminate them. (2) Early on in product development where sample volumes are extremely limited, particle analysis is rarely carried out, despite the desire to do so. This is because of the large volumerequirements and the slow nature of current techniques. The Horizon technology addresses these problems with a new imaging technique that can differentiate between important classes of particles. The analysis uses a tenth the volume of current techniques, is at least 10 times faster and is fully automated. The proposed research will involve internal validation followed by a multi-site study to show robustness and demonstrate the utility of the technique on real pharmaceutical samples at GSK. Horizon will speed up biopharma product development time and improve the quality and safety of biotherapeutics by enabling routine particle identification.