Gateway Analytical announced today that they will be presenting on chemically-specific particle analysis in addition to exhibiting at the upcoming Bioequivalence: Intersection between Science & Regulatory Conference in San Diego, California, on November 5th-6th.
The focus of the Bioequivalence Conference is to help bridge the gap between the scientific community and regulatory agencies in order to safely bring a new drug to market. Attendees will share and address specific case studies and examples on how to clarify and simplify the bioequivalence testing process, to help ensure a faster time to market for future drug products. During the conference, Gateway Analytical Senior Scientist, Dr. Oksana Olkhovyk will be presenting a poster session titled “Understanding the Power of Chemically-specific Analysis for Formulation Development and Establishing Bioequivalence in Your Drug Product.” This session will discuss how chemically-specific analysis using Raman spectroscopy and imaging provides drug manufacturers with detailed insight into complex drug formulations that other common technologies do not provide.
In addition to the session, Gateway Analytical will be exhibiting at the conference to promote their chemically-specific particle sizing services that provide critical data for drug innovators looking to advance their formulation development and generic developers trying to establish bioequivalence. “One of the key challenges generic drug developers of nasal and inhalation products face when preparing their formulation for FDA submission is the proper identification of agglomerates. Developers must be able to prove that the amount of agglomeration meets the requirements of the brand drug via bioequivalence” said David Exline, Senior Vice President at Gateway Analytical. “Only by utilizing our patented Raman chemical imaging method can you obtain spectral information on every pixel in the data, which provides identification and characterization of the agglomerate. This allows us to see what the agglomerate is composed of, such as two active pharmaceutical ingredients (API), or an API and an excipient. This chemical specificity helps put Gateway and the forefront for helping formulators better understand their drug product, and ready it for FDA submission.”
Gateway Analytical is a full service, cGMP compliant, ISO 17025:2005 certified, FDA registered and inspected laboratory with specialized expertise in techniques for chemically specific analysis and particulate contamination identification. For more information on Gateway Analytical services, contact Tracey Safran, Senior Account Manager
