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West Analytical Services Particle Lab partners with customers to develop methods for analyzing unique drug delivery or containment products as well as utilize existing West component-specific methods. The Particle Lab performs testing to support every phase of your drug product from compatibility studies through to commercialization and lifecycle management. With the ability to handle biosafety level 1 and 2 drug products, our ability to partner and design studies to meet your portfolio of drug products is extensive.
Particle characterization and identification capabilities:
Glass delamination remains a significant concern for the storage of biologics. This is especially the case for large molecule formulations with high pH levels. The Particle Lab can perform glass delamination testing using Differential Interference Contrast Microscopy (DICM) to determine if glass delamination has the potential to occur on selected glass. In addition, the Particle Lab has the capability to perform particle counting and sizing for sub-visible and visible particles using:
FlowCam®
The FlowCam® 8100 (Yokogawa Fluid Imaging Technologies) is used for sub-visible particle analysis. The instrument captures digital images of particles suspended in liquid as they pass through a flow cell. Each individual particle captured in the field of view has over 40 morphological characteristics, which can be used to create image libraries for particle characterization. The instrument uses the 21 CFR Part 11 compliant software program VisualSpreadsheet® to process captured images and generate customizable reports containing particle count and size.
The FlowCam 8100 can be used to monitor particle levels in drug products and can be used as a complement to Light Obscuration (LO) analysis for early phase compatibility studies. It is especially convenient for biologics because of the small sample volume requirements - as little as 300 µL per sample analysis.
Understanding particle origin and being able to differentiate between intrinsic (related to manufacturing process), extrinsic (foreign to manufacturing process) and inherent (related to product) particles is critical to understanding the risks associated with particles in the formulation. The FlowCam, which enables particle characterization, allows for determination of particle type which can provide a deeper understanding of the particles that are present in drug products.
FlowCam® and VisualSpreadsheet® are registered trademarks of Fluid Imaging Technologies, Inc.
By Your side with Analytical Solutions From West: Particle Analysis with USP Chapter 788: Method 1
By Your side with Analytical Solutions From West: Particle Analysis with USP Chapter 788: Method 2
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.
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