Datwyler, a leading provider of high-quality, system-critical elastomer components, expanded its NeoFlex range of fully coated plungers with a solution for large-volume cartridges containing 20mL. Announced at Pharmapack in Paris, France, the launch responds to rising demand for on-body devices for subcutaneous (SC) delivery of biotherapeutics to patients seeking convenient at-home care.

Overcoming the Challenges of Large-Volume Drug Delivery

Alongside the increased use of biologics, which are predominantly delivered intravenously, requiring long visits to healthcare facilities, preference is shifting to SC delivery enabling at-home administration to support patient comfort and convenience. As a result, demand for on-body delivery devices is growing. However, pharmaceutical and medical device manufacturers face key challenges in outfitting these therapies for large-volume subcutaneous (SC) delivery:

• High-dose and high-volume biologics remain difficult due to limitations in formulation concentration.
• There is limited availability of standardized large-volume, device-compatible components.
• There is a need for off-the-shelf delivery solutions reducing development complexity, cost and time in a highly competitive market.

The NeoFlex fully coated plunger for cartridges containing up to 20mL volumes enables slow, controlled drug delivery and supports a wider range of self-administration devices. It presents a pre-verified solution to overcome these hurdles, saving companies up to three years of development time.

Designed for Complex Formulations

Datwyler’s new plunger for cartridges containing up to 20mL volumes delivers all the benefits of its NeoFlex range in a specially sized component for large-volume drug delivery applications.

• NeoFlex plungers are completely covered in a non-fluorosurfactant grade fluoropolymer coating that ensures a contact safe surface compatible with the formulation and prohibiting exposure to extractables, leachables, and other contaminants.
• Datwyler manufactures its NeoFlex plungers at its FirstLine facilities to deliver the highest level of quality assurance and risk mitigation with cleanroom environments, automated production cells, and 100% camera inspection.
• NeoFlex plungers provide dependable performance by maintaining container closure integrity under demanding conditions, while their consistent and minimal gliding forces enable accurate dosing.

Advancing Patient Care through Collaboration

Datwyler’s new plunger is compatible with all 20mL ISO cartridges currently on the market.

“We believe in innovating patient care through open collaboration,” said Paolo Ferrigno, Product Manager, PFS & Cartridges, Datwyler. “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.”

Additionally, Datwyler worked with system suppliers, device developers, and fill-finish machine suppliers to design a 20 ml NeoFlex plunger that meets all their requirements.

In billions of syringes and in every second car around the world, Datwyler components make an important contribution to patient and driver safety. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, automotive, industries and food & beverage. Datwyler materializes ideas for a safer, smarter, and more sustainable world. Thanks to recognized core competencies, the company offers added value to its customers as a development partner. With 25 production sites on four continents, revenue in over 100 countries and more than 7’500 employees, the company generates annual revenue of more than CHF 1’100 million. Headquartered in Switzerland, Datwyler has been listed on the SIX Swiss Exchange since 1986.