PITTSBURGH, April 16th, 2015 — Gateway Analytical announced today that they will be presenting an interactive workshop titled “Assessing Aggregate Performance and the Presence of Foreign Particulates in OINDPs” on Wednesday, May 6, 2015, from 2:00 pm to 6:00 pm at the Congress Center during Respiratory Drug Delivery (RDD) Europe 2015, May 5th-8th, in Antibes, France.
The workshop, which will be presented by Dr. Oksana Olkhovyk, Senior Scientist at Gateway Analytical, will inform participants on the FDA regulations related to control of impurities of a chemical or microbiological nature. The workshop will cover a number of techniques suitable for solid-state characterization of OINDPs.
During the workshop, participants will learn about validated methodologies for accurate, reproducible chemically specific particle sizing and aggregate classification, along with techniques for identifying foreign particulates. Knowledge of the conditions promoting foreign particulates and drug particle adhesion can help aid the understanding of OINDPs bioavailability, stability and efficacy.
“Establishing and proving bioequivalence of inhaled combination therapies can be difficult without accurately and precisely measuring the particle size distribution of individual active pharmaceutical ingredients and source determination of any foreign particulate matter.” said Dr. Oksana Olkhovyk. “During this workshop I will discuss specifically how Raman spectroscopy and chemical imaging can help address these concerns.”
In addition to the workshop, Gateway Analytical will also be exhibiting at RDD Europe (booth #46) to promote their analytical testing services and special expertise in chemically specific particle sizing and particulate identification. Attendees are invited to stop by the booth to speak with Gateway Representatives about their services or to ask questions about the workshop.
Gateway Analytical is a full service, FDA registered and inspected laboratory with specialized expertise in techniques for chemically specific particle sizing and particulate contamination identification. The lab is cGMP compliant, following 21 CFR parts 210 & 211, 21 CFR part 820, and ICH Q7. Accreditations include ISO 9001:2008, ISO 17025:2005, and ASCLD/LAB-International.
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.
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.