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Supporting pharmaceutical partners from early development through commercialization with high-performance elastomer components and technical collaboration.
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Explore technical resources and industry perspectives
Double Sterilization in Pharmaceuticals: The Impact of Annex 1 on Component Strategy
Since the 2022 revision of EU GMP Annex 1 came into effect in August 2023, sterile manufacturing strategy has become one of the most consequential decisions in injectable drug development. What was once a binary choice between aseptic processing and terminal sterilization is shifting toward a hybrid "double sterilization" model — purchasing pre-sterilized, ready-to-use elastomeric components and then applying terminal sterilization again after filling and final assembly.
Lyophilization is growing in pharma, but technical challenges persist
In this technical article, Datwyler's Camille Ermine explores how lyophilization is reshaping pharmaceutical packaging decisions for biologics, mRNA therapeutics, ADCs, and orphan drugs — covering stopper geometry, moisture control, container closure integrity, and extractables and leachables risk, and how the right component choices help manufacturers navigate the fill-finish challenges that come with freeze drying.
The evolving landscape of subcutaneous drug administration
Connect with Datwyler Healthcare at industry-leading events
CPHI Milan
Datwyler takes the stage twice at CPhI Milan 2026 — Paolo Ferrigno presents "From Infusion to Self-Injection: The New Era of Subcutaneous Drug Delivery" on October 7, and Robert Lindner joins the panel "Large Volume Drug Delivery Trade Off: The Patient Choice Dilemma." Visit Booth #11A73 at Fiera Milano, October 6–8.
PDA Universe of Pre-Filled Syringes & Injection Devices
Festival of Biologics
Datwyler joins the biologics community in Basel for three days of scientific exchange, innovation showcasing, and strategic discussion on the future of biologic drug development and delivery. Our team engages with biotech and biopharma leaders to explore how purpose-built container closure systems — from silicone-free components to ready-to-use formats — support the integrity and stability of sensitive biologic molecules.
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