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To support customers as they navigate the path from drug product discovery to commercialization, West has undertaken a new, proactive strategy: Integrated Solutions. For almost 100 years, West has been developing technical and regulatory expertise in primary drug packaging, delivery devices, and combination products. That wealth of industry experience is now offered to customers who can employ it for any stage of development (Prescreen and Compatibility, Clinical Phases I / II / III, and Lifecycle Management).
The need for a strategy such as Integrated Solutions was confirmed by a survey of the over 300 registrants for West’s recent webinar: Navigating Particle Challenges in Sterile Drugs from Component to Patient. Over half of respondents’ report issues with particles resultant from drug/package incompatibility with vials, cartridges or syringes. Further revealed was lack of uniformity on how measurements of particles are made, what conditions are employed, and whether statistical analysis methods are used. Clearly, customers need the support that Integrated Solutions offers.
Particles is a thrust area for West – having the staff, expertise and facilities to design and execute studies needed regarding particle issues – more specifically being able to accurately determine the type, size, concentration and origin of particles in a drug product container system – in particular particles resulting from drug product interactions. The Integrated Solutions strategy helps to Simplify the Journey™ for customers and helps to reduce risk. For more information, contact an Account Manager or Technical Customer Support (TCS) representative.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
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.
Coring and fragmentation are two typical events that can occur when a needle is pierced through a vial closure to withdraw drugs from the vial or expel drugs into the vial.
An extraction study is sometimes thought of by customers as an expensive and time-consuming exercise for filing. However, extractables studies are more than that. Performing an extraction study provides a thorough understanding of the materials used. It is a study that takes into account the primary packaging components and provides an understanding of the chemical species that may potentially come out over the shelf-life of a product.
In aseptic pharmaceutical manufacturing, the packaging for parenteral packaging components is essential for ensuring proper sterilization and utilization. The importance cannot be overstated. Ineffective component packaging can potentially affect patient safety, and result in significant financial loss. Acknowledging this, West conducts exhaustive testing on its packaging systems to ensure that quality and functionality requirements are achieved.
West is committed to the safe and efficient delivery of drug products to patients. An important aspect of this commitment is engagement in standards-setting organizations; West is a member of the European Pharmacopoeia Commission, Group of Experts 16 – who contributed to European Pharmacopoeia 9.5 (effective July 2018).<br /><div> </div>
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