The Particle Articles

PITTSBURGH, June 2^nd, 2014 — Gateway Analytical announced today that they will be exhibiting at the 3rd Annual ISPE-FDA CGMP Conference in Baltimore, Maryland, June 2-4^th. The ISPE-FDA CGMP Conference promotes and presents the latest topics in different areas of the pharmaceutical industry including quality, innovation, technology and regulatory affairs. At this event, attendees and exhibitors benefit from having direct interaction and discussions with the FDA and leading experts in the areas of drug development and manufacturing.

Overview

Glass delamination if not discovered early can be big problem for pharmaceutical manufacturers. It has the potential to cause costly product recalls and investigations. Because of this, the FDA highly recommends that manufacturers perform stability studies to evaluate the interaction of the drug formulation with the glass vial in addition to pretesting analysis on smaller batches of the product before going into full production.

PITTSBURGH, April 24^th, 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.

PITTSBURGH, March, 11^th, 2014 — Gateway Analytical announced today that they have collaborated with researchers from the Division of Pharmaceutical Analysis at the Food and Drug Administration’s Drug Evaluation and Research Center (FDA/CDER) to present new findings on temperature-mediated agglomeration assessment in Orally Inhaled and Nasal Drug Products (OINDP’s) at the upcoming Respiratory Drug Delivery (RDD) conference in Fajardo, Puerto Rico, May 4-8, 2014.

Henry Ford once said, “Quality means doing it right when no one is looking.” Here at Gateway Analytical we take great pride in the quality of the work we do, knowing that we provide our customers with a top notch product. The quality of the work is directly related to the commitment to overall quality, starting at the top of our organization.

Gateway Analytical has teamed up with researchers from the Division of Pharmaceutical Analysis at FDA/CDER to present new findings on temperature-mediated agglomeration assessment in Orally Inhaled and Nasal Drug Products. This study was performed to address aqueous nasal spray suspensions stability during long-term shipping/storage. During the study, suspension formulations were subjected to temperatures that may possibly be reached inside shipping containers during hottest and coldest months in St. Louis, MO.

PITTSBURGH, January, 21 2014 — Gateway Analytical announced today that they have acquired the RapID SPE-ls raman.ID + metal.ID® system, the latest technology in automated particle identification. This acquisition enhances existing analytical service offerings to the pharmaceutical and materials science industries, and makes Gateway one of only two analytical service laboratories in the United States that can offer this advanced technology.

Original Event Date: Tuesday, December 17, 2013
Duration: 60 minutes
Presenters: David Exline, Senior Vice President & Antonio Scatena, Laboratory Manager at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical

On November 20th, Antonio Scatena, Laborator Manager and Cara Plese, Scientist at Gateway Analytical hosted a webinar designed for scientists working in the pharmaceutical industry. During this webinar, they discussed the advantages of using Raman analysis in conjunction with other analytical techniques, such as microscopy, SEM/EDS and FTIR in investigations to identify unknown materials. They discussed the sample types that are best suited for Raman analysis and tips on how to discover the best parameters to use for you investigation. They also discussed how Raman Analysis can be used to analyze inorganic materials, such as metal oxides, pigments and minerals which would typically not yield results with FTIR analysis.