Articles & Publications

November 18, 2010 With expertise in standardized USP testing, cGMP regulations, process development and pharmaceutical forensics, Gateway Analytical’s pharmaceutical services support many facets of the drug product lifecycle. No matter what the phase of development, our goal is to provide reliable results with a quick turnaround. Discover Gateway Analytical services and staff in this short

January 07, 2011 In any investigation, every piece of evidence has a story to tell. Whether it is hair, paint or an unknown material, our forensic services produce accurate, legally defensible results that will help you reconstruct the event. Discover Gateway Analytical forensics services and staff in this short video that presents an overview of

January 07, 2011 Understanding the fundamental properties of materials is essential to product development and manufacturing processes. Our multi-analytical approach to scientific problem solving can give you just that — vital information about a product’s raw materials, manufacturing environment, packaging and processes. Discover Gateway Analytical materials testing services and staff in this short video that

Authors & ContributorsDavid Exline March 17, 2011 In this one-on-one interview with Dave Exline, Senior V.P. at Gateway Analytical he discusses how Gateway Analytical specializes in applying forensic testing and consulting methods to examine evidence from suspected false insurance claims, product liability claims, accident investigations and a variety of other insurance related investigations.

Authors & ContributorsDavid Exline March 22, 2011 In this one-on-one interview with Dave Exline Senior V.P. at Gateway Analytical discusses how Gateways pharmaceutical forensic analytical testing services tie into this years Annual PDA conference theme of “Harnessing the Power of Knowledge to Drive World Class Science and Technology”.

Authors & ContributorsDavid Exline March 24, 2011 In this one-on-one interview with Dave Exline, Senior V.P. at Gateway Analytical discusses what pharmaceutical forensics is and the application of forensic testing methods to address pharmaceutical issues such as identifying when and where foreign particulate matter enter a manufacturing process, pinpointing the root cause of product failures

Authors & ContributorsDavid ExlineJanuary 08, 2013 Recently on December 22nd, Dave Exline, Senior V.P. at Gateway Analytical stopped by the Pittsburgh Technology Council’s TechVibe Radio to talk on-air with Audrey Russo and Jonathan Kersting about Gateway Analytical and its services. During the show, Dave discussed the various analytical testing and consulting services the company offers

June 13, 2013 Gateway Analytical Senior Scientist Oksana Olkhovyk, Ph.D. recently presented at RDD Europe 2013 in Berlin, Germany. The workshop titled: “Automated Ingredient Specific Particle Sizing” is now available for download. Download Workshop: Automated Ingredient Specific Particle Sizing This workshop detailed validation methodology for drug PSD based on Raman Chemical Imaging, demonstrating benefits of ISPS as a reliable

June 17, 2013 Raman spectroscopy is a vibrational spectroscopy method which is based upon inelastic scattering of a monochromatic excitation source. This type of scattering is often referred to as “Raman scattering.” As such, Raman spectroscopy is undoubtedly a spectroscopic technique which can stand on its own; however, it is routinely considered a complimentary technique

Authors & ContributorsRebekah Byrne July 10, 2013 This function has a great deal of utility when performing materials analysis, whether the goal is product development, failure analysis, or reverse engineering.  Manual analysis certainly has its advantages when a quick, general overview of a sample is effective. However sometimes the end goal of an examination requires a

Authors & ContributorsRebekah ByrneJuly 22, 2013 Fourier transform infrared spectroscopy, or FTIR, is a vibrational spectroscopy method which is based upon the measurement of specific frequencies which occur between chemical bonds in a given material. Interestingly, as materials may be unique in chemical nature, so are the infrared spectra which they yield, resulting in a

Authors & Contributors David Exline October 09, 2013 Raman spectroscopy is an inelastic scattering phenomenon the probes molecular vibrations to provide a molecular fingerprint of materials. Currently, there are six major types of Raman spectroscopy in use today, which are: Spontaneous Raman Spectroscopy, Resonance Raman spectroscopy (RRS), Surface Enhanced Raman spectroscopy (SERS), Coherent Anti-Stokes Raman

June 17, 2014 Outsourcing the development and manufacturing of generic drug products is a very common strategy in today’s current global market. Because of this, some of the biggest generic manufacturers of orally inhaled and nasal drug products (OINDPs) are located overseas. As a result, evaluating out-of-specification issues, establishing batch-to-batch equivalency, addressing the stability of

Authors & Contributors Rebekah Byrne March 25, 2015 We get some FAQs here in the analytical lab…one recurring question here at Gateway is “Why did/didn’t you do Raman?”  During foreign particulate matter investigations, the use of spectroscopy is pretty common.  Spectroscopy allows us to study the way a material interacts with energy, in order to

Authors & Contributors Rebekah ByrneDavid ExlineEmily Landsperger March 27, 2015 Foreign particulate matter in drug products is a common problem in the pharmaceutical industry that can have major impacts on pharmaceutical companies, from both financial and safety aspects. While manual particulate characterization is best suited for many investigations, automated Raman and automated Scanning Electron Microscopy/Electron

Authors & Contributors Rebekah Byrne June 04, 2015 Glass delamination(1) has become a bit of a hot topic in the area of parenterals over the past several years. Glass delamination is, indeed, a serious issue which can not only cause pharmaceutical companies millions of dollars in recalls, but also stands as a safety hazard to end

Authors & ContributorsEmily Landsperger March 06, 2018 Glass delamination, which is a reaction from a form of glass corrosion, are small, thin, glass fragments, termed “glass lamellae”, which are shed from the interior portion of glass containers and vials. USP 1660 describes a methodology for evaluating various glass vials under simulated conditions. The results from

March 07, 2018 Particulate matter in injections is defined as extraneous particles, unintentionally present in the end product. These contaminants can come from various sources, including the environment, packaging materials and undissolved formulation ingredients. Particulate matter can be harmful when introduced into the bloodstream. Therefore, the US Pharmacopeia places limits on the amount of sub-visible

Authors & ContributorsEmily LandspergerMarch 07, 2018 Particulate matter, in both parenteral and ophthalmic drug products, consists of extraneous mobile, undissolved particles, other than gas bubbles, unintentionally present in the solutions. These particles can originate from various sources including, but not limited to: the environment, the manufacturing process, packaging materials and undissolved formulation ingredients. This particulate

Authors & ContributorsDavid Exline June 05, 2018 The active pharmaceutical ingredient (API) size distribution within the final formulation of a drug product is critical as it relates to bioavailability, rates of absorption, and stability of that drug product. Due to the potential significant impact related to the active pharmaceutical ingredient (API) size and shape, gaining

Authors & ContributorsDavid Exline June 05, 2018 Drug release speed is determined by the complex relationships between the polymer matrix used, the layer thickness, membrane permeability, if any, and the content and concentration of drug. When API is suspended in either a reservoir or inert polymer matrix, it is important to assess its physical form,

Authors & ContributorsDavid ExlineJune 05, 2018 Foreign particulate matter in drug products is a common issue in the pharmaceutical industry that has major impacts on pharmaceutical companies, from both financial and safety aspects. The purpose of this study is to discuss the application of a freeze/ thaw method using a low concentration of sodium hydroxide to

Authors & ContributorsDavid ExlineEmily Landsperger June 06, 2018 Part of USDA requirements for in vitro bioequivalence testing is particle size distribution and agglomerate analysis of the budesonide suspension in the ampoules of both the generic product for submission and the reference listed drug. Automated optical microscopy with Raman characterization, and automated Scanning Electron Microscopy – Energy Dispersive

Authors & Contributors David Exline June 06, 2018 Intranasal drug delivery is an attractive delivery method for a broad range of pharmaceuticals that treat a variety of diseases. This patient-friendly delivery method can provide multiple benefits like the reduction in potential side effects and increased compliance of the drug treatment. The development of an efficient

Authors & Contributors David ExlineEmily Landsperger April 01, 2019 This article provides an introduction to automated scanning electron microscopy—energy dispersive spectroscopy (SEM-EDS) and the capabilities it can offer in development of inhalable drug products. Case studies are presented for a foreign particulate matter investigation of a metered dose inhaler (MDI); an active pharmaceutical ingredient (API)-specific