Datwyler says it has developed a first-to-market universal plunger for large-volume cartridges containing up to 20mL. Adding to Datwyler’s line of NeoFlex fully coated plungers, it answers demand for on-body devices for subcutaneous biotherapeutics delivery.

Datwyler Plunger’s Usefulness

According to Datwyler, biologics, which are seeing increased use, are predominantly delivered intravenously. This requires long visits to healthcare facilities. As such, at-home administration involving subcutaneous drug delivery is a growing patient preference.

However, challenges remain. These include limitations in formulation concentration and availability of standardized components, and complexity, cost, and time concerns in a competitive market.

Having a “pre-verified solution,” as Datwyler puts it, to overcome manufacturing hurdles can save companies up to three years in development time.

Large-Volume Demands

By offering a plunger for up to 20mL volumes, Datwyler says slow, controlled drug delivery across many devices is possible.

“We believe in innovating patient care through open collaboration,” said Paolo Ferrigno, Datwyler Product Manager, PFS & Cartridges. “So, we are proud to deliver the first-to-market universal, fully coated plunger in this size, helping our peers across pharmaceutical and medical device companies continue to improve the patient experience in receiving high-dose therapies.”

Datwyler, Other Companies Innovating

Datwyler’s announcement came the same day BD and Ypsomed announced they developed a 5.5ml version of a glass prefillable syringe. In that case, the companies said they were also responding to patient self-injection trends.

The Datwyler plunger features a non-fluorosurfactant grade fluoropolymer coating, ensuring a contact-safe surface, according to the company. This also prohibits exposure to extractables and leachables, among other contaminants.

Container closure integrity is maintained, Datwyler said, under demanding conditions. Additionally, consistent and minimal gliding forces enable accurate dosing.Manufacturing is done in cleanroom environments incorporating automated production cells and camera inspection, to ensure quality assurance and risk mitigation.