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We are delighted to share that West has been honored at the Korea Bioprocessing Excellence Awards (KBEA) for the second year in a row. This year, we were recognized as the grand winner of the Best Bioprocessing Supplier Award: Fill-Finish.
The award ceremony was held in association with the 10th Biologics Manufacturing Korea Virtual Conference on June 23-24, 2021. Kwon DongOh, Managing Director of Korea, attended the ceremony and accepted the award on behalf of West. Kwon said: “It’s an honor to receive the award and we’ll keep working by the side of customers to ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients”.
Congratulations to the entire team on this well-deserved award! Click here for more information if you are interested in how West partners with customers to align drug packaging, containment and delivery products with services, solutions, and support.
<p>Amy Miller and Jennifer Riter</p><p>Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for an extractable to leach into the drug product and the impact that leachable will have on the drug’s stability, efficacy and toxicity needs to be scientifically evaluated. </p>
<p><em>Part 3 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director, </em><em>Xavier University. This is the third installment in a four-part series on supply chain management.</em></p><p>At the outset of the Integrity of Supply Initiative, an assumption was that suppliers cannot consistently supply what is needed. However, it was discovered through our research that manufacturers often do not know what specifications are actually needed, do not involve suppliers in development discussions, do not explore the full expertise of suppliers, do not understand their own process well enough to know how the incoming material will impact their process, and do not ask for the process capability of their suppliers.</p>
Vial adapters are a cost-effective solution for the safe and rapid reconstitution and transfer of drug products. They not only provide needle-free transfer of liquid for reconstitution, but also enable consistent withdrawal of drug product from a vial. By providing such consistent withdrawal, the use of vial adapters can aid in reducing the amount of required overfill (extra drug product in a vial to address the fact that not all drug product can be removed), which may result in cost savings.
In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.
We are pleased to announce our recent publication in the November/December 2019 Issue of the International Journal of Pharmaceutical Compounding. In the article “How to Qualify Container Closure Systems, Part 1,” we address how compounding pharmacies (503Bs) can qualify systems for intended use via container closure integrity (CCI) to meet FDA Guidance requirements.<sup>1</sup>
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