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Recently, there has been increased scrutiny from regulatory authorities to quantify and qualify subvisible particles in biopharmaceutical products. Such particles, which can cause a protein to denature, are of concern to pharmaceutical manufacturers since they can affect the efficacy of the drug product. As regulatory bodies continue to raise the bar on quality, industry is looking for “zero defect” and particle free components as well as a way to minimize quality variation.
While there are no standardized definitions for particulate sizing, subvisible particles are generally considered to be particulate in the range of 1 to 25 µm. In its recent “Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 3 Test for Particulate Contamination: Subvisible Particles General Chapter,” the FDA offered a non-binding recommendation for an insoluble particulate matter test for injections. The test is harmonized with the European and United States pharmacopeias. The insoluble particulate matter test for injections or infusions is designed to test for subvisible particulate and includes two possible procedures: Light obscuration Particle Count Test and the Microscopic Particle count Test. The FDA notes that it may be necessary to conduct both tests to ensure that the injectable product conforms to requirements.
For customers concerned about subvisible particles, West offers NovaPure® components, which West developed using a comprehensive quality target product profile (QTPP) that included a subvisible particle specification as part of the component critical quality attributes (CQAs).
Features and processes that help ensure reliability include:
-FluroTec® barrier film – a proven, effective barrier against extractables that also provides lubricity without the need for silicone oil
-Validated wash and sterilization processes that help ensure consistency of stopper preparation
-100 percent vision verification to assure extremely low levels of visual defects
-Lot-to-lot extractable profile to assure material consistency
For more information about NovaPure, click here.
NovaPure® and FluroTec® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec technology is licensed from Daikyo Seiko, Ltd.
<p><em>Component manufacturing process designed with Quality by Design principles meets the high-quality needs of pharmaceutical manufacturers and patients </em></p><p>West has introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting. Through a product development process that incorporates Quality by Design principles, NovaPure components, including serum and lyophilization stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products.</p>
The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. In biotherapeutics, critical attributes related to efficacy, potency, clinical safety, and immunogenicity can be affected by PM.<sup>1-3 </sup><br />PM is defined as extraneous mobile undissolved particles (excluding gas bubbles) that are unintentionally present in solutions.<sup>4</sup><br />Several USP chapters describe the measurement of PM, namely:
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
The development of a drug product is an arduous and intricate process. Besides ensuring the sterility and effectiveness of the final product, it should also be as free of particles as possible. In protein-based pharmaceuticals, aggregates may form over time and are mostly detrimental to product quality, as they can affect the efficacy, potency, clinical safety, and immunogenicity of the product.<sup>1-3</sup> Protein aggregates are considered a type of particulate matter (PM), and it is important to minimize their occurrence, as well as to quantify the PM for ensuring the quality and safety of the drug products.
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
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