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Gateway Analytical to Present with the FDA on Chemically Specific Analysis of Orally Inhaled Drug Products at the Respiratory Drug Delivery Conference in Puerto Rico

[fa icon="calendar"] Apr 24, 2014 6:00:13 AM / by Admin

PITTSBURGH, April 24th, 2014 — Gateway Analytical announced today that they will be exhibiting and presenting at the upcoming Respiratory Drug Delivery (RDD) conference in Fajardo, Puerto Rico, May 4-8. 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 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 extend of agglomerations in orally inhaled drug products (OINDPs), which is critical for safety, stability and FDA submission.

Gateway will also be presenting on chemically specific analysis in a poster session (co-authored with the Division of Pharmaceutical Analysis at the Food and Drug Administration’s Drug Evaluation and Research Center) titled “Chemically Specific Analysis of OINDP: Differentiation of Drug Particle Agglomeration by Raman Chemical Imaging”. This poster will present the results of a collaborative study that reviewed the effects that can occur in aqueous nasal spray suspensions during long term shipping or storage conditions. Having the knowledge of the environmental conditions and their effects on OINDPs may benefit developers of formulations containing multiple APIs and/or excipients such as nasal suspensions, dry powder inhalers and metered dose inhalers. “We are excited about participating in the discussions and presenting our study with the FDA during the poster session at RDD this year. We recognize that being able to obtain chemically specific information on agglomerates in a drug product formulation will prove even more critical as requirements become more stringent for FDA submission in the years to come, and with our Raman chemical imaging 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.

In addition to the exhibit and poster presentation, Gateway will also be hosting a sunset sail special VIP event for their existing customers and select RDD attendees to kick off the first evening of the conference on May 5th. This networking event will serve as an opportunity for Gateway representatives to discuss current industry topics and showcase how chemically specific analysis can support drug developers, while they enjoy food, cocktails and a Puerto Rican sunset.

Gateway Analytical is a full service, cGMP compliant, FDA registered and inspected laboratory with specialized expertise in techniques for chemically specific analysis and particulate contamination identification. For more information on Gateway Analytical’s chemically specific services, contact Tracey Safran, Senior Account Manager at safrant@gatewayanalytical.com.

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About Gateway Analytical

Based in Gibsonia, Pa., Gateway Analytical, LLC partners with companies in need of high-quality laboratory analysis that do not have the time, resources or capabilities for specialized, comprehensive testing. Through conventional and innovative testing methods, the company provides expert laboratory services and analytical solutions for the pharmaceutical, forensic and materials science industries.

Gateway Analytical is a subsidiary of ChemImage Corporation, a leader in chemical imaging technology and instrumentation.

About ChemImage

ChemImage Corporation, a leader in hyperspectral and Raman chemical imaging technology provides innovative instrumentation, analysis software, contract services and expert consulting to government, industrial and academic organizations. The company’s proprietary, state-of-the-art imaging technology has many applications, including defense, security, pharmaceuticals, forensics and biomedical diagnostic research, which can reveal critical chemical and biological information from a variety of material systems.

ChemImage’s headquarters are located in Pittsburgh, PA, where it pioneers research and development, as well as providing engineering and manufacturing which develops innovative products for the global marketplace.

Topics: Blog, chemically specific analysis, Drug Particle Agglomeration, FDA submission, Ingredient-Specific Particle Sizing, News Releases, OINDPs, Raman chemical imaging, RDD 2014

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