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.
Quality Means Doing it Right When No One is Looking
[fa icon="calendar'] Feb 25, 2014 7:00:10 AM / by Admin posted in Blog, Quality Assurance, Quality Corner
Gateway Analytical Teams up with Researchers from the FDA/CDER/Division of Pharmaceutical Analysis to Present at RDD 2014
[fa icon="calendar'] Feb 13, 2014 3:57:56 PM / by Admin posted in agglomeration assessment, aqueous suspension formulations, Blog, chemically specific, FDA, Nasal Drug Products, Pharmaceutical, Raman chemical imaging
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.
Gateway Analytical Acquires RapID System to Meet Growing Market Demand
[fa icon="calendar'] Jan 30, 2014 4:30:19 AM / by Admin posted in Blog, foreign particulate, News Releases, particle counting, particle identification, particle sizing, RapID
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.
Raman-based Analysis of Dispersed Versus Aggregated Drug Particles in MDI Formulations for Chemically-specific Sizing and Polymorphic Purity Assessment
[fa icon="calendar'] Dec 19, 2013 11:59:14 AM / by Oksana Olkhovyk posted in Blog, Posters & Presentations
Presented at: Drug Delivery to the Lung 24, 2013
Authors: O Olkhovyk1, R Price 2 and J Shur 2
1. Gateway Analytical, 5316 William Flynn Highway, Gibsonia, PA 15044
2. University of Bath, Bath, BA2 7AY, UK
Release Date: Thurs., Dec 12, 2013
Challenges of Analyzing Commonly Encountered Mixtures
[fa icon="calendar'] Dec 19, 2013 11:20:38 AM / by Admin posted in Blog, material characterization, Material Science Replays, Materials Science, Pharmaceutical, Pharmaceutical QA/QC Investigations Webinars, product contamination issues, reverse engineering, spectral databases, Recorded Webinars, microscopy
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
Q&A Recap from Value of Raman Analysis in Pharmaceutical Investigations
[fa icon="calendar'] Dec 12, 2013 3:03:55 PM / by Admin posted in Blog, FTIR spectroscopy, Pharmaceutical, pharmaceutical drug products, Raman analysis, Raman spectral libraries, SEM/EDS, microscopy
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.
Crystal City V – FDA and Industry Discuss Crucial Draft Bioanalytical Method Validation Guidance
[fa icon="calendar'] Dec 6, 2013 9:00:00 AM / by Admin posted in AAPS, American Association of Pharmaceutical Scientists, Bioanalytical Method Validation, biotechnology, Blog, contract research organizations, Pharmaceutical, pharmaceutical
Recently, the American Association of Pharmaceutical Scientists (AAPS) released a post on their blog authored by Binodh DeSilva, Executive Director of Immunochemistry and Biomarker Development and Mark E. Arnold, Ph.D., Executive Director of the Bioanalytical Sciences and Selective Integration Department at Bristol Myer Squibb on the FDA and industry discussing crucial draft bioanalytical method validation guidance. Here is an excerpt from the post:
Can You Hear Me Now?...What About Now?
[fa icon="calendar'] Dec 5, 2013 9:21:52 AM / by Admin posted in Blog, communication, Quality Assurance, Quality Corner, quality system, training
In the day and age of emails, texts and social media; communication has become an ever present topic of discussion. After all, why would Led Zepplin take the time to sing about communication (and its breakdown…) if it wasn’t such a large part of our lives? But even with all the new technology we have at our fingertips today, communication has always been something that professionals are expected to master and execute with ease. This is an especially important skill set when considering quality, as communication is imperative to not only the maintenance of quality systems but also their proliferation.
A 2013 AAPS Annual Meeting Recap
[fa icon="calendar'] Nov 25, 2013 9:45:56 AM / by Admin posted in AAPS, bioequivalence, Blog, chemically specific, drug manufacturing, Pharmaceutical, pharmaceutical formulation, sem-eds
For the third consecutive year Gateway had the pleasure of exhibiting at the AAPS Annual Meeting, which was held this year in San Antonio, at the very large Henry B. Gonzalez Convention Center. AAPS members and attendees come from a wide range of areas within pharmaceutical drug development and biopharmaceuticals. In addition to offering free popcorn daily and an open bar on Tuesday night, this year, our focus was to promote analytical services that not only support drug product formulation development but also address manufacturing issues such as particulate contamination and source determination.
A Forensic Approach to Particulate Contamination in Inhalable Drug Products
[fa icon="calendar'] Nov 1, 2013 9:12:05 AM / by Admin posted in Articles & Publications, Blog, Pharmaceutical
Published in Inhalation Magazine’s (www.inhalationmag.com) August 2013 issue featuring Rebekah Byrne, Scientist and David Exline, Senior Vice President of Gateway Analytical