Posters and Presentations

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Gateway Analytical is well-represented at top technical conferences around the globe, where our scientists often present on our unique capabilities and findings. Our posters and slides are below.

Gateway Analytical to Present at 2012 MAAFS Meeting: The Introduction of Hyperspectral Imaging as an Additional Method of Examination for Tapes

Authors & Contributors Cara Plese May 10, 2012 The Mid-Atlantic Association of Forensic Scientists (MAAFS) annual meeting is being held later this month from May 14th through the 18th.  MAAFS is one of several regional/state forensic science associations in the United States.  Regional meetings are great for scientists to attend because they usually require less travel than attending the national AAFS meeting, and

RDD 2012: Investigation of the Microstructure of Combination Dry Powder Inhaler Formulations by Atomic Force Microscopy and Raman Chemical Imaging

May 20, 2012 The microstructure of combination DPI formulations is complex and is related to the surface interfacial interactions between components of the formulation, which define the structure and thereby performance of the formulation (1, 2, 3). Previous studies have attempted to investigate the microstructure of combination DPI formulations using a combination of atomic force

CRS 2012: Analysis of Particle Agglomeration and Content Uniformity by Raman Imaging

July 30, 2012 Examination of drug particle size distributions (PSD), the extent of drug particle aggregates and content/blending uniformity is an important part in characterization of pharmaceutical products as it directly correlates with the dissolution rate of the Active Pharmaceutical Ingredient (API). Such characterization is also necessary for measuring product quality as well as establishing

INTFG Fall Symposium: Method Validation Study for the Preparation and Analysis of Ingredient-Specific Particle Sizing by Raman Chemical Imaging as it Relates to the Generic Nasal Spray Suspensions

September 14, 2012 Accurate, objective and precise drug particle size distribution (PSD) assessment is basis for safely expediting the approval of pharmaceuticals and reducing their development cost. The FDA’s Critical Path Initiative has identified a specific need to determine in vitro drug PSD in generic nasal spray formulations, indicating if such information were obtained in an accurate

DDL 2012: Assessment of Drugs and Carrier PSD in a Commercial Combinational Dry Powder Inhaler Post Multistage Cascade Impaction Analysis by Raman Imaging

December 07, 2012 Authored by scientists at Gateway Analytical and University of Bath, this poster takes a look at how Raman Chemical Imaging (RCI) was used to investigate the active pharmaceutical ingredients (API), particle size distribution (PSD), carrier (Lactose) PSD and access qualitatively, a degree of API-carrier aggregation in a commercial DPI, ADVAIR DISCUS® 500/50

IFPAC 2013 Presentation: Forensic Analysis of Foreign Particles in Pharmaceutical Materials

Authors & Contributors Rebekah Byrne February 26, 2013 At this years IFPAC – 2013 27th International Forum and Exhibition Process Analytical Technology, I gave a presentation titled Forensic Analysis of Foreign Particles in Pharmaceutical Materials. The presentation focused on the presence of foreign particulate matter and other contaminants that can halt the production of drug products

AAFS 2013 Presentation: What Judges and Lawyers Need to Know about the Science Behind Trace Evidence

Authors & ContributorsCara PleseAntonio Scatena March 04, 2013 Gateway Analytical scientists Cara Plese and Antonio Scatena recently presented at the 2013 AAFS Annual Meeting in Washington DC. The presentation titled: “What Judges and Lawyers Need to Know about the Science Behind Trace Evidence” is now available for download. This presentation is specifically for attorneys and judges and gives a brief technical

RDD 2013: Polymorph Identification of Drug Particles in Orally Inhaled and Nasal Drug Products

June 04, 2013 Authored by Oksana Olkhovyk, Ph.D., at Gateway Analytical , this poster presents new qualitative and semi-qualitative methods for the examination of size and polymorph drug particle identification in finished products. Specifically, its benefits for BA/BE testing is described using the model of fluticasone-containing nasal spray suspension formulation. Poster Summary Polymorphs are chemicals

DDL 2013: Raman-based Analysis of Dispersed Versus Aggregated Drug Particles in MDI Formulations for Chemically-specific Sizing and Polymorphic Purity Assessment

December 19, 2013 In this study, Raman Chemical Imaging (RCI) was used to investigate the active pharmaceutical ingredients (API) particle size distribution (PSD) and degree of drug particle aggregation in a commercial MDI, Flixotide, which contains an anti-inflammatory corticosteroid (fluticasone propionate). Assessment of free-standing API particles and aggregated API particles was done by visual inspection

RDD 2014: Chemically Specific Analysis of OINDPs: Differentiation of Drug Particle Agglomeration by Raman Chemical Imaging

April 08, 2014 Proper characterization of pharmaceutical products with respect to particle size and distribution requires that the extent and size of drug particle agglomerates is determined, as well as the size and number of primary Active Pharmaceutical Ingredients (API) particles. Such characterization may also be necessary for assessing product quality, establishing Bioequivalence (BE), evaluating

2014 ASSA International IWPCPS-16 Workshops: Spatially-Resolved Raman Imaging for Ingredient-Specific Characterization of Combination Dry Powder Inhalers

June 17, 2014 Since the approval of Dry Powder Inhalers containing Fluticasone Propionate and Salmeterol Xinafoate in 1999, combination inhaled therapies have dominated the COPD market. However, due to the lack of specific guidance of the Office of Generic Drugs  as to the abbreviated new drug application submission, there was very little attempts of generic

2014 IACP Conference: The Evolution of Gunshot Residue Analysis

Authors & Contributors David Exline Emily Landsperger Cara Plese November 19, 2014 Gunshot residue analysis is a common request in forensic laboratories with cases that question whether or not anindividual fired a firearm. When a firearm is fired, several types of residues are expelled from the openings on the firearm. Primer residues, specifically, are detected in GSR analysis.

AAPS 2014: Foreign Particulate and Glass Delamination Investigations using Automated Raman/LIBS

Authors & ContributorsRebekah ByrneDavid ExlineEmily Landsperger November 19, 2014 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 /LIBS analysis can offer additional insight

DDL 2014: Chemically-specific Characterization of Particulate in Inhalable Drug Products using Raman and Laser-induced Breakdown Spectroscopy

December 11, 2014 The impact of foreign particulate and agglomerates on dissolution profile and permeability of the inhalable drug particles within the sites of action (i.e. patient’s lungs) is critical. In this study, Raman Chemical Imaging (RCI) and Raman/ Laser-induced breakdown spectroscopy (LIBS) were used to investigate the Active Pharmaceutical Ingredients (API) Particle Size Distribution

RDD 2015 Workshop: Assessing Aggregate Performance and the Presence of Foreign Particulate in OINDPs

May 19, 2015 Establishing bioavailability and proving bioequivalence of inhaled combination therapies can be difficult without addressing two major concerns: accurate and precise particle size distribution data of the individual active pharmaceutical ingredient and source determination of the any existing foreign particulate matter. Raman spectroscopy and Raman chemical imaging have the potential to address the

RDD 2016: API-Specific Particle Size Distribution and Agglomerate Analysis using the rap.ID Single Particle Explorer (SPE)

Authors & ContributorsDavid ExlineEmily LandspergerApril 20, 2016 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 significant impact, gaining an understanding of this API particle size distribution (PSD) is becoming

2017 PDA Annual Meeting: Beyond the Count

Authors & ContributorsRebekah ByrneDavid ExlineEmily Landsperger April 11, 2017 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

2017 RDD Europe: Advancing the Determination of In Vitro Similarity in Tiotropium Formulations for Inhalation

Authors & ContributorsDavid Exline May 09, 2017 Three dry powder formulations of tiotropium bromide were manufactured for in vitro comparison to Spiriva® HandiHaler®. In this study, aerodynamic particle size distribution (APSD) characterization techniques that simulate patient conditions coupled with particle chemistry, morphology and size analysis were used to determine differences in the tiotropium bromide formulations.

2017 AAPS Annual Conference: Two-Sample T-Test for the Determination of Optimal API Sample Size for Particle Population Studies

Authors & ContributorsDavid Exline December 12, 2017 A common scientific question, specifically in the area of Active Pharmaceutical Ingredient (API) particle size distribution, is the optimal sample size for analyzing a particle population. Many times, the answer is merely a suggestion or preference. However, by understanding simple statistical ideas, we can provide a basis for

2017 DDL Dual Automated Approach for Sizing and Characterizing Budesonide In Suspension

Authors & ContributorsDavid ExlineEmily Landsperger December 19, 2017 Budesonide is a corticosteroid that is commonly administered by means of a nebulizer to help prevent symptoms of asthma, when regularly inhaled. The suspension contains the ingredients micronized budesonide (API), citric acid, edetate disodium dehydrate, polysorbate 80, sodium chloride, sodium citrate and water for injection; however, all

AAPS 2017 Development and Validation of a cGMP Compliant Particulate Characterization Database

Authors & ContributorsRebekah ByrneDavid ExlineDecember 19, 2017 Reference databases catalog data and information for known materials, process and product related materials, and archived foreign particulate. In a simple process with few particulates and few reference materials, a hard copy catalog with pictures and spectra may suffice. However, for operations that generate numerous particulate with many

2018 PDA Annual Meeting: A Proactive Approach to the Particulate Management Lifecycle in Parenteral Drug Products

Authors & ContributorsDavid ExlineCara Plese March 22, 2018 The inspection, detection, characterization and source determination of foreign particulate matter in parenteral drug products is a critical aspect to the drug manufacturing process. Methodologies exist to address many of these phases. However, a cohesive program is vital to any parenteral drug manufacturer to manage the entire

2018 RDD Conference: Analysis of a Dry Powder Inhaler Active Pharmaceutical Ingredient Using Scanning Electron Microscopy

Authors & ContributorsDavid ExlineEmily Landsperger May 07, 2018 Automated SEM-EDS has been evaluated as a potential tool for determining the API particle size distribution (PSD) andmorphological characteristics, such as aspect ratio and roundness of particles, of a DPI. The only requirementfor this technique is an elemental distinction, such as the presence of an inorganic element in