West Synchrony™ Prefillable Syringe System Launches at CPHI: Redefining a system-level solution for drug delivery
West Pharmaceutical Services (NYSE: WST) launched the West Synchrony™ Prefillable Syringe (PFS) System at CPHI Worldwide and said the system will be commercially available in January 2026. The system is described as a fully verified, system-level solution for biologics and vaccines that provides a single design verification and characterization package, a single system-level drug master file and regulatory package, and single-source supply options with make-to-stock and make-to-order and low minimum order quantities.
Management positioned the offering as intended to streamline syringe selection, accelerate regulatory submissions, and secure supply chains, while also cautioning that forward-looking statements contain risks and that there is no certainty the product will achieve particular results.
West Pharmaceutical Services (NYSE: WST) ha lanciato il West Synchrony™ Prefillable Syringe (PFS) System a CPHI Worldwide e ha dichiarato che il sistema sarà disponibili commercialmente a gennaio 2026. Il sistema è descritto come una soluzione completamente verificata a livello di sistema per biologici e vaccini che offre un pacchetto unico di verifica e caratterizzazione del progetto, un unico file master di droga a livello di sistema e pacchetto regolatorio, e opzioni di fornitura a sorgente unica con make-to-stock e make-to-order e minimi d'ordine bassi.
La direzione ha inquadrato l'offerta come pensata per semplificare la scelta della siringa, accelerare le submission regolatorie e mettere in sicurezza le catene di approvvigionamento, pur avvertendo che le dichiarazioni prognostiche comportano rischi e che non vi è certezza che il prodotto raggiunga determinati risultati.
West Pharmaceutical Services (NYSE: WST) lanzó el Sistema de jeringa prellenable West Synchrony™ (PFS) en CPHI Worldwide y dijo que el sistema estará disponible comercialmente en enero de 2026. El sistema se describe como una solución completamente verificada a nivel de sistema para biológicos y vacunas que proporciona un paquete único de verificación y caracterización de diseño, un único archivo maestro de medicamentos a nivel de sistema y paquete regulatorio, y opciones de suministro de fuente única con make-to-stock y make-to-order y bajos mínimos de pedido.
La dirección posicionó la oferta como destinada a facilitar la selección de jeringas, acelerar las presentaciones regulatorias y asegurar las cadenas de suministro, al tiempo que advirtió que las declaraciones prospectivas conllevan riesgos y que no hay certeza de que el producto logre ciertos resultados.
West Pharmaceutical Services (NYSE: WST)가 West Synchrony™ Prefillable Syringe (PFS) System을 CPHI Worldwide에서 출시했으며 이 시스템은 2026년 1월 상용화될 예정이라고 말했다. 이 시스템은 생물학적 제제 및 백신에 대해 완전히 검증된 시스템 차원의 솔루션으로 설명되며, 단일 설계 검증 및 특성화 패키지, 단일 시스템 차원의 의약품 마스터 파일 및 규제 패키지, 재고 생산(make-to-stock) 및 주문 생산(make-to-order)과 함께 낮은 최소 주문 수량으로 단일 소스 공급 옵션을 제공한다.
경영진은 이 제안을 주사기 선정의 간소화, 규제 제출의 가속화 및 공급망 확보를 목표로 포지션했으며, 동시에 앞으로의 진술에는 위험이 수반되며 제품이 특정 결과를 달성할 것이라는 확실성이 없다고 경고했다.
West Pharmaceutical Services (NYSE: WST) a lancé le Système West Synchrony™ Syringe Pré-remplie (PFS) lors de CPHI Worldwide et a déclaré que le système sera disponible commercialement en janvier 2026. Le système est décrit comme une solution entièrement vérifiée au niveau du système pour les biologiques et les vaccins qui offre un paquet unique de vérification et de caractérisation de la conception, un seul fichier maître de médicaments au niveau système et un paquet réglementaire, et des options d'approvisionnement à source unique avec make-to-stock et make-to-order et des quantités minimales de commande faibles.
La direction a positionné l'offre comme destinée à simplifier la sélection des seringues, accélérer les soumissions réglementaires et sécuriser les chaînes d'approvisionnement, tout en avertissant que les déclarations prospectives comportent des risques et qu'il n'y a aucune certitude que le produit atteigne des résultats particuliers.
West Pharmaceutical Services (NYSE: WST) hat das West Synchrony™ Prefillable Syringe (PFS) System auf der CPHI Worldwide vorgestellt und mitgeteilt, dass das System voraussichtlich im Januar 2026 kommerziell verfügbar sein wird. Das System wird als eine vollständig verifizierte systemweite Lösung für Biologics und Impfstoffe beschrieben, die ein einzelnes Design-Verifizierungs- und Charakterisierungspaket, eine einzige systemweite Arzneimittel-Master-Datei und ein regulatorisches Paket sowie Optionen für eine Ein-Quelle-Versorgung mit Make-to-Stock und Make-to-Order und niedrigen Mindestbestellmengen bietet.
Das Management positionierte das Angebot dahingehend, die Siringen-Auswahl zu straffen, regulatorische Einreichungen zu beschleunigen und Lieferketten zu sichern, warnte jedoch auch, dass zukunftsgerichtete Aussagen Risiken enthalten und es keine Gewissheit gebe, dass das Produkt bestimmte Ergebnisse erzielt.
West Pharmaceutical Services (NYSE: WST) أطلقت نظام West Synchrony™ لسِرْنِجة قابلة للإعداد مسبقاً (PFS) في CPHI Worldwide وقالت إن النظام سيكون متاحاً تجارياً في يناير 2026. يوصف النظام بأنه حلٌ على مستوى النظام ومُحقق بالكامل لـ المستحضرات الحيوية واللقاحات يوفر حزمة تحقق وتحديد التصميم واحدة، وملف رئيسي واحد للأدوية على مستوى النظام وحزمة تنظيمية، وخيارات توريد من مصدر واحد مع Make-to-Stock وMake-to-Order وبحدود دنيا منخفضة للطلب.
أشارت الإدارة إلى أن العرض يهدف إلى تبسيط اختيار الحقن، وتسريع التقديمات التنظيمية، وتأمين سلاسل الإمداد، مع التحذير من أن البيانات المستقبلية تحمل مخاطر وأنه لا يوجد يقين بأن يحقق المنتج نتائج محددة.
West Pharmaceutical Services (NYSE: WST) 在 CPHI Worldwide 推出 West Synchrony™ 可预装注射器（PFS）系统，并表示该系统将于 2026 年 1 月上市销售。该系统被描述为面向 生物制药产品和疫苗 的完全部署验证的系统级解决方案，提供单一的设计验证与表征包、单一系统级药物主文件及法规包，以及具有现货制造与按需生产的单一来源供应选项，且最低订购量较低。
管理层将该方案定位为旨在简化注射器选择、加速监管提交并确保供应链，同时也提醒前瞻性陈述存在风险，且不确定该产品是否会实现特定结果。
- Commercial availability set for January 2026
- Fully verified system-level solution for biologics and vaccines
- Single system-level drug master file and regulatory package
- Single-source supply with make-to-stock and low minimums
- Company states no certainty Synchrony will achieve any particular result
- Risk from dependence on third-party suppliers and partners
- Supply-chain interruptions or weaknesses could affect delivery
Insights
West launches a validated, single‑supplier prefillable syringe system for biologics and vaccines, commercially available
The announcement positions West Synchrony™ PFS as a system‑level product that bundles design verification, characterization data, and a single system‑level drug master file to streamline syringe selection and regulatory submission. Selling a fully verified platform from one supplier can reduce integration time that developers spend qualifying components, and it creates a clearer procurement path by offering make‑to‑stock and make‑to‑order options with low minimums.
Outcomes hinge on adoption by pharmaceutical customers and the regulatory acceptance of the supplied submission package; the company itself notes risks such as changing customer manufacturing plans, dependence on third‑party suppliers, and supply chain interruptions. The product’s commercial impact will depend on the pace at which biologics and vaccine developers switch from multi‑supplier sourcing to a single‑supplier validated system.
Concrete items to watch: customer qualification timelines and announced design wins, regulatory filings that cite the West system, and actual order flow after commercial availability in
The West Synchrony PFS system delivers a fully verified system-level solution designed specifically for biologics and vaccines. It sets a new standard in drug delivery by accelerating syringe selection through its comprehensive performance and regulatory data packages.
"Leaders in drug development face pressures to meet milestones efficiently amid complex challenges, amongst them, selecting prefillable syringes. They currently rely on fragmented approaches—assembling component data from multiple suppliers or outsourcing piecemeal verification, which risks delays, increased costs and regulatory setbacks," said Andy Polywacz, President of Integrated Systems at West. "With West Synchrony prefillable syringe system, it enables pharmaceutical companies to streamline design, accelerate regulatory submission, and secures a reliable supply chain for combination products that meets quality and volume needs."
Key benefits of the West Synchrony PFS system include:
- Design and System-Level Performance: a single design verification and characterization package from West ensures the form, fit and function of the entire PFS system.
- Regulatory Ease with Comprehensive Submission: a streamlined submission process with one system-level drug master file and regulatory package tailored for comprehensive regulatory needs.
- Single Source Supply: single supplier approach, offering make-to-stock and make-to-order supply with low minimum order quantities, ensuring reliability and flexibility.
For more information about West Synchrony PFS system, click here.
For more information about CPHI Worldwide, click here.
Forward-Looking Statements
Certain forward-looking statements are included in this press release. They use words such as "standard," "streamline," "accelerate," "secures," "reliable," "meets," and other similar terminology. These statements reflect management's current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations. Specifically, there is no certainty that West's introduction of the Synchrony PFS system will achieve any particular result. These forward-looking statements involve a number of risks and uncertainties. Various factors could cause the actual results to differ materially from those expressed in, or underlying, these forward-looking statements, such as customers' changing inventory requirements and manufacturing plans; customer decisions to move forward with new products and product categories; average profitability, or mix, of the products offered for sale; dependence on third party suppliers and partners; interruptions or weaknesses in the supply chain; increased raw material costs; fluctuations in currency exchange; and the ability to meet development milestones with key customers. These important factors are not all inclusive. For a description of certain additional factors that could cause West's future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled "Risk Factors," in West's Annual Report on Form 10-K for the year ended December 31, 2024. Except as required by law or regulation, West undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
About West
West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With over 10,000 team members across 50 sites including 25 manufacturing facilities worldwide, West helps support our customers by delivering over 41 billion components and devices each year.
Headquartered in
All trademarks and registered trademarks used in this release are the property of West Pharmaceutical Services, Inc. or its subsidiaries, in the United States and other jurisdictions, unless otherwise noted.
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SOURCE West Pharmaceutical Services, Inc.
FAQ
What is the West Synchrony PFS system announced by West (WST) on October 27, 2025?
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Does the West Synchrony PFS system offer supply flexibility for WST buyers?
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