The core rationale for switching from a vial to a PFS is that it helps sterile injectable manufacturers manage the brand life cycle of their products, offers significant benefits to healthcare providers (HCPs) and patients, and can help drastically cut …

2022年2月21日 · Martin Gonzalez discusses some of the most relevant engineering activities that are necessary to transfer a product successfully from a vial into a prefilled syringe presentation.

Learn how lifecycle planning strategies, regulatory insights, & packaging can help to enable smooth transition and successful product launches.

The core rationale for switching from a vial to a PFS is that it helps businesses manage the brand lifecycle of their products, offers significant benefits to healthcare providers (HCPs) and patients, and can help cut manufacturing and product costs.

2009年9月1日 · For injectable therapeutics, one way to accomplish this goal is to move a product's presentation from a vial to a prefilled syringe. A prefilled syringe helps to increase dosing accuracy, convenience, and safety; enhance …

There are many technical processes that must be followed when migrating a drug product from traditional vials to PFS devices. Making this process a success requires close collaboration between pharmaceutical companies and their CDMOs, as well as concerted efforts across all quality, engineering, validation, procurement and regulatory departments.

2022年12月9日 · This note outlines the benefits of PFS transfer and the key engineering processes required to successfully carry out this process.

2024年5月31日 · Therefore, a transition from a vial to an SC injection device is common for biologics and can occur either during clinical development or post-launch. These devices include PFSs, autoinjectors, pen injectors and OBIs. When switching to an SC injection device, either during or after clinical trials, the following scenarios are possible:

More specifically, providing options for moving a drug product from a vial into a pre-filled syringe (PFS). There are many reasons why a drug developer may be interested in converting a drug product currently provided in a vial form into a PFS.

Transitioning from a vial to a prefilled syringe (PFS) is a complex process, and it is important to understand the impact that your drug packaging selection can have on the success of the lifecycle of the drug, in all packaging formats that you plan to bring to market.