We're the contract R&D lab of choice providing chemical and materials analysis solutions for process control optimization and quality control services. Gateway Analytical is a leading analytical services laboratory providing chemical analysis and materials analysis solutions. Since 2011 we have created value for the pharmaceutical, medical devices, and forensics industries, in addition to industries where materials quality matters most, including aerospace, defense, marine, automotive, and energy production. Our expert staff of chemists, biochemists, materials scientists, and forensics analysts leverages deep interdisciplinary knowledge and experience to find answers.
Method I (using light obscuration) and Method II (using membrane microscopy)
Method I (using light obscuration) and Method II (using membrane microscopy)
Foreign particulate analysis can identify contaminants present in your drug product. It's the first step to improving overall product quality and drug safety.
Whether confirming the presence of particulates identified during visual inspection or responding to an FDA inquiry, foreign particulate analysis is the first step to resolving contamination issues in the pharmaceutical industry. After identifying foreign materials in your pharmaceutical product it's important to understand their composition and determine the potential impact on safety and quality and their ultimate source.
We use a multi-tiered analytical approach when conducting foreign particulate testing, which generally involves two key steps: identification and analysis. Our experts select the appropriate techniques for sample preparation and testing so that we can provide a comprehensive and informative identification. In general, microscopy is used to understand properties and appearance, FTIR and/or Raman spectroscopy is used to obtain a molecular fingerprint of the material in question, and SEM-EDS is used to obtain elemental information to help determine source.
Particle sizing, counting, and identification analysis provides a detailed accounting of foreign particulate matter present in a pharmaceutical product.
The presence of foreign materials in pharmaceutical products and medical devices can impact the immediate and long-term safety of the product. However, these foreign particles are often below the size range that can be manually manipulated. Gateway Analytical utilizes specialized sample preparation techniques to collect foreign particulates from drug products and automated high-throughput techniques to accurately determine elemental, spectral, and morphological information.
Our particle sizing, counting, and identification services allow our customers to analyze large populations of particles down to submicron scales within a matter of hours. This automated service can be performed on organic, inorganic, and metallic materials.
More specifically, our experts use SPE-Raman to count and size particles as small as 2 microns, while automated SEM-EDS can find particles down to the submicron level. All data are reported in size bins as requested by the customer. Additionally, we have the ability to build customer-specific reference databases to fast-track sourcing and root cause analysis services.
Particle size distribution significantly impacts drug product efficacy, which makes ingredient specific particle sizing a requirement for today's regulatory environment.
The size of the particles present within a drug product, including both the active pharmaceutical ingredient (API) and excipients, can significantly affect bioavailability and efficacy. Therefore, it is important to understand particle size distribution of ingredients to fully assess a pharmaceutical product and influence formulation development. This is especially true for generic drug developers, where bioequivalence studies can expedite marketing approval decisions from the FDA.
Gateway Analytical provides particle size distribution testing that allows our customers to obtain ingredient specific size information for nasal sprays, inhalable drugs administered through metered dose inhalers (MDI) and dry powder inhalers (DPI), creams, gels, ointments, and more. The information provided can be used to compare expected uptake, mode of action, and effect between two drug preparations, such as an innovator formulation and a generic challenger.
Our experts perform this service in two phases: Feasibility and Full Testing. During Feasibility, we assess the ability to distinguish specific ingredients. This is determined using Raman spectroscopy (RCI, SPE-Raman, or manual confocal Raman) to build a spectra reference library of the pure components comprising the drug product. Once established, we conduct Full Testing to determine ingredient specific particle size distribution, conduct statistical analyses, and collect representative particle images and spectra.
Raw materials analysis ensures your drug development process begins with high-quality substances that minimize impact on final product quality.
The outputs are only as good as the inputs. Optimizing manufacturing processes won't get you very far if you don't first consider the quality of the raw materials. Contaminants and impurities present in the inputs can negatively impact final product quality, performance, and safety. Determining the level of impurities that begins to compromise final products will help you to maintain quality manufacturing processes, avoid costly recalls, and even allow you to optimize supply chain volatility and process costs.
Gateway Analytical provides proactive and reactive raw materials analysis. This service allows our customers to have peace of mind knowing their products will continue to meet the most stringent quality standards, or to quickly determine if starting raw materials are the possible source for end product foreign particulate matter. Our experts utilize an all-of-the-above approach that may include microscopy, FTIR, Raman, and/or SEM-EDS depending on a project's unique needs.
Polymorph identification in pharmaceuticals ensures the API within your drug product exhibits the intended behavior.
The FDA often requires polymorph data when evaluating a New Drug Application or Abbreviated New Drug Application. Why? A single active pharmaceutical ingredient (API) can exist in different crystalline and structural forms that, although chemically identical, demonstrate varying levels of efficacy, safety, stability, and bioavailability. Making matters more complex, polymorphism can result at any time during a drug product's market journey, from formulation preparation to final product transportation and storage.
Gateway Analytical offers polymorph identification for any stage of drug development or the post-market life for product formulations of nasal sprays, inhalable drugs administered through metered dose inhalers (MDI) and dry powder inhalers (DPI), creams, gels, ointments, and more. Our experts perform this service in two phases: Feasibility and Full Testing.
During Feasibility, we determine which Raman technique (RCI, SPE-Raman, or manual confocal Raman spectroscopy) can best differentiate between various polymorphic forms of interest for our specific customer's formulation. Once the testing technology is optimized, we provide spectral overlays exhibiting the technology’s capability to distinguish polymorphic forms, an assessment of the polymorphic form of the crystals analyzed, and a statement of conclusion from polymorph identification testing.
Glass delamination testing is necessary to analyze the durability of glass containers and their interactions with specific drug products.
A storage container can have a significant impact on the shelf life and quality of your pharmaceutical drug product, which makes it important to understand the potential risks presented by glass delamination. The phenomenon occurs when the surface of a glass container breaks down and sheds thin flakes of glass (termed "lamellae") into solution. If the problem is detected in a marketed product, then you could be faced with expensive recalls, regulatory investigations, and damage to your brand's reputation.
Gateway Analytical offers both proactive and reactive glass delamination testing capabilities. Stability studies can be conducted during drug development to assess the suitability of glass containers for specific drug products (USP<1660>). Similarly, the presence or absence of active glass delamination can be detected within products, such as vials rejected during visual inspection.
We rely on high resolution SEM images acquired from the interior surfaces of glass containers, using a secondary electron detector, to show signs of breakdown in the surface. Microscopy and SEM-EDS can then be used to analyze lamellae present. Inductively coupled plasma (ICP) and pH / conductivity testing can be requested for full USP<1660> testing, which is conducted at an approved subcontract lab.
Gateway Analytical LLC has not received any reviews.
Gateway Analytical LLC has not received any endorsements.