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The definitions of personalized medicine vary. However, all of them indicate that the once popular therapy approach of “one drug fits all” is outdated. The Council of the European Union defines personalized medicine as “[p]roviding the right treatment to the right patient, at the right dose at the right time.”[1].
Advancement in personalized medicine has been enabled by advancements in the field of pharmacogenomics [combines the fields of Pharmacology (science of drug action) and Genomics (science of genes and their functions)]. Within the patient population, responses to many drugs can vary, as patients’ phenotypes and genotypes vary. Responses to a drug can range from showing a positive impact, to showing no impact, to showing a negative impact.[2] Tailoring the therapeutic strategy in response to individual patients can have manifold benefits – for the patient as well as the healthcare system.
Personalized medicine has implications in the pharmaceutical industry, creating the need for: (a) more flexibility on fill-finish lines, enabling efficient small batch production of drugs, and (b) more flexibility in availability of primary packaging components, especially in small volumes. Always committed to the safest and most efficient delivery of drug products to patients, West offers the Ready Pack® brand product line – ideally suited to personalized drug products and small batch production. Ready Pack® components comprise high-quality vial, stopper and seal components – available quickly and conveniently in small volumes and delivered in sterile, ready-to-use format. They are a commercial-grade vial containment system with proven container closure integrity (CCI) that lends itself to research and development as well as small-scale manufacture. Available sterilization validation summaries for Ready Pack® components provide additional confidence in product quality and integrity. For more information on Ready Pack® components, and how they can support your drug product, contact a Technical Customer Support (TCS) representative.
Diane Paskiet, Director Scientific Affairs, will provide an update on the PQRI-PODP working group at the Smithers Rapra Extractables and Leachables conference in Barcelona, Spain on November 10-12, 2014.
Recently, 16 of the interns from the 2019 West Ambassador Internship Program visited two West sites in Jersey Shore and Williamsport, Pennsylvania. As interns from the corporate headquarters, the tours of the two local manufacturing locations offered a unique perspective to contrast the corporate experience. During the Jersey Shore and Williamsport tours, the interns were given a different experience to visualize the making of the product itself.
Selecting the best vial container closure system (CCS) components and capping process for a drug product ensures optimal performance and patient safety. An optimized CCS requires compatible components (rubber stopper, aluminum seal, glass or polymer vial) and proper capping setup. This provides predictable sealing performance, which maintains the container closure integrity (CCI) needed for patient safety and visual acceptance.
Biosimilar development and approvals have been accelerated over the last several years. The rapid uptake in this category is due in large part to clarity on regulatory pathways that demonstrate interchangeability with the reference product and key patent expiry over the next decade. By 2025 injectable biosimilars are projected to comprise almost 50% of the accessible biologics market<sup>1</sup>. West recently conducted a survey of biosimilar companies to better understand their top needs for packaging and support services during drug development.
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