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As biosimilar development is expected to accelerate over the next decade, many customers are seeking packaging recommendations for these drug products. Because biosimilars are extremely sensitive to any changes from the innovator’s manufacturing and packaging processes, in every case it is important to understand the factors that affect the safety, purity and potency of the drug product as it relates to component selection.
From a packaging perspective, the most important concern for most biosimilars is protein aggregation. Protein aggregation may be caused by metal extractables, most notably tungsten in glass prefilled syringes (PFS), manganese in stainless steel PFS needles, and zinc in some elastomer cure systems. Metals can also be introduced from the vial or syringe through glass ion exchange. It is well documented that particulate is a known contributor to protein aggregation, which often enters the container closure system as an artifact of the component manufacturing process or through the use of silicone oil on elastomers or syringe barrels. Additionally, surface adsorption often plays a key role in protein aggregation, as many proteins can adsorb to the surface of a vial, syringe barrel or elastomer.
Using Quality by Design methodologies, West has designed components specifically for the use of biologic and biosimilar drug products. With low metallic extractable elastomers, FluroTec® film for reduced surface adsorption, subvisible particle specifications and 100% vision verification, West stoppers and plungers help reduce the risk of protein aggregation. Daikyo Crystal Zenith® vials and syringes are proven alternatives to glass. West’s safety and administration systems and self-injection technologies provide additional ways to help differentiate a biosimilar drug product from the innovator and competitors.
Please contact your technical customer support representative to see what data is available to better understand the role of packaging in biosimilar drug development.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
From August 5-6, 12 employees from West’s Grand Rapids facility participated in a 200 mile, overnight relay race. The Fred 200 Mile Relay spans the Fred Meijer White Pine Trail through Comstock Park and Cadillac, MI. This was the third year that our Grand Rapids, Michigan facility coordinated a team for the Relay.
Want to learn more about quality planning for injectable delivery systems? Join West’s technical experts on April 24, 2012 at the Renaissance Raleigh North Hills Hotel for a free educational seminar.
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.<br />
Overview of EU GMP Annex 1<br />EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.<sup>1</sup> It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few. The objective is to ensure product quality and potency, as well as patient safety, by minimizing risks of microbial, particulate and endotoxin/pyrogen contamination through manufacturing and environmental controls.<br />In August 2022, the final draft of EU GMP Annex 1 was released after years of development and took effect on 25 August 2023. In this blog, a summary of the key changes of relevance to primary packaging components and how West can help with the implementation will be discussed.
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