PRE-STERILIZED / READY-TO-USE PRIMARY PACKAGING MARKET

Category: Health

Primary packaging, such as vials, syringes, and cartridges, and their affiliated closures, play a vital role in ensuring the stability, and sterility, and thereby, the overall quality, efficacy and safety of a drug product. Moreover, the packaging bears the product label, which provides information related to the drug and, in certain cases, dosing instructions. Pharmaceutical packaging is typically carried out under controlled conditions; specifically, for therapeutics that are designed for parenteral administration, fill / finish is carried out in sterile and aseptic environments. It is also crucial for innovators (or packaging service providers) to choose the appropriate, high quality primary packaging for their respective products; this is because the packaging material is in direct contact with the drug / therapy. Building and maintaining the necessary expertise and infrastructure to support pharmacological fill / finish is a capital-intensive ordeal. Further, the growing complexity of modern pharmacological interventions, such as monoclonal antibodies, cell and gene therapies (which are typically produced in small batches) and the gradual (but imminent) shift to personalized therapies, has prompted drug developers to look for leaner manufacturing and packaging solutions. In this context, cost optimization is important and one of the available ways to save both time and capital is by bypassing manual processing and sterilization of primary packaging and switching to ready-to-use (RTU) formats.