PITTSBURGH, April 6, 2016 — Gateway Analytical announced today that they will be exhibiting and presenting at the upcoming Respiratory Drug Delivery (RDD) conference in Phoenix, Arizona, April 17-20. RDD is an international conference that features in-depth presentations and discussions focused on the latest development in respiratory drug delivery science, in addition to industry networking. During the conference, Gateway Analytical will be promoting a wide array of analytical testing services that focuses on supporting manufacturing quality control, including foreign particulate matter identification, root cause analysis, contaminate source determination, and out-of-specification investigation support. In addition, Gateway will be promoting their unique Raman chemical imaging services that provide drug developers with truly chemically specific particle characterization. This chemical specificity is the key to understanding the extent of agglomerations in orally inhaled drug products (OINDPs), which is critical for safety, stability and FDA submission.
Gateway Analytical Scientist, Emily Landsperger, will be presenting a poster titled “API-Specific Particle Size Distribution and Agglomerate Analysis Using the Rap.ID Single Particle Explorer (SPE),”during the RDD poster session on Active Pharmaceutical Ingredients (API). This poster will present the results of a study that reviewed the API size distribution within the final formulation drug products, including nasal sprays, metered dose inhalers, and dry powder inhalers. Having this knowledge is critical as it relates to bioavailability, rates of absorption, and stability of that drug product. “We are excited about participating in the discussions and presenting our study during the poster session at RDD this year. We recognize that being able to obtain specific information on API’s and agglomerates in a drug product formulation will prove even more critical, as requirements become more stringent for FDA submission in the years to come. With our capabilities, we stand at the forefront of being able to provide this significant information to developers,” said David Exline, Senior Vice President at Gateway Analytical.
Gateway Analytical is a full service, cGMP compliant, ISO 17025:2005 compliant, FDA registered; and inspected laboratory with specialized expertise in techniques for materials analysis and foreign particulate matter contamination identification. For more information on Gateway Analytical pharmaceutical investigation services, contact us at [email protected] or visit our website, Gatewayanalytical.com.
