Emerging Personalized Medicine is Increasing the Need for Flexible Small Batch Production
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 However, all of them indicate that the once popular therapy approach of “one drug fits all” is outdated.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.”.
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. 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.
 General Secretariat of the Council to Delegations; Document Number 15054/15: Personalized Medicine for Patients – Council Conclusions (7 December 2015): http://data.consilium.europa.eu/doc/document/ST-15054-2015-INIT/en/pdf, retrieved 14 Dec 2017
 Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development. T. Simoncelli, et al. Issued by US FDA. https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf]
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