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WuXi Biologics Germany to Enhance Capabilities with New Prefilled Syringes Line

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WuXi Biologics announced plans to enhance its drug product capabilities at its Leverkusen, Germany facility with a new sterile filling line for prefilled syringes (PFS). The new line will handle multiple syringe sizes at up to 400 syringes per minute, with an annual capacity of 17 million syringes. This adds to the existing filling and freeze-drying line's capacity of 10 million doses annually. Construction will begin recently with GMP compliance targeted for 2026. The expansion supports WuXi Bio's Global Dual Sourcing strategy and aims to meet growing client demand for drug product services.

WuXi Biologics ha annunciato piani per migliorare le sue capacità di produzione di farmaci presso il suo stabilimento di Leverkusen, in Germania, con una nuova linea di riempimento sterile per siringhe pre-riempite (PFS). La nuova linea sarà in grado di gestire più dimensioni di siringhe, fino a 400 siringhe al minuto, con una capacità annuale di 17 milioni di siringhe. Questo si aggiunge alla capacità della linea esistente di riempimento e liofilizzazione di 10 milioni di dosi all'anno. I lavori di costruzione inizieranno recentemente, con l'obiettivo di conformità GMP per il 2026. L'espansione supporta la strategia di approvvigionamento globale duale di WuXi Bio e punta a soddisfare la crescente domanda dei clienti per i servizi di prodotti farmaceutici.

WuXi Biologics anunció planes para mejorar sus capacidades de producto farmacéutico en su instalación de Leverkusen, Alemania, con una nueva línea de llenado estéril para jeringas precargadas (PFS). La nueva línea manejará múltiples tamaños de jeringas a una velocidad de hasta 400 jeringas por minuto, con una capacidad anual de 17 millones de jeringas. Esto se suma a la capacidad existente de la línea de llenado y liofilización de 10 millones de dosis anuales. La construcción comenzará recientemente, con el objetivo de cumplir con las normas GMP para 2026. La expansión apoya la estrategia de abastecimiento global dual de WuXi Bio y tiene como objetivo satisfacer la creciente demanda de los clientes de servicios de productos farmacéuticos.

우시 바이오로직스(WuXi Biologics)는 독일 레버쿠젠에 있는 시설에서 프리필드 시린지(PFS)에 대한 새로운 무균 충전 라인을 도입하여 의약품 생산 능력을 강화할 계획을 발표했습니다. 새로운 라인은 분당 최대 400개의 시린지를 처리할 수 있으며, 연간 1,700만 개의 시린지를 생산할 수 있는 능력을 갖추고 있습니다. 이는 기존 충전 및 동결 건조 라인의 연간 1,000만 도스 생산 능력에 추가되는 것입니다. 건설은 최근에 시작될 예정이며, GMP 준수는 2026년을 목표로 합니다. 이번 확장은 우시 바이오의 글로벌 이중 조달 전략을 지원하며, 의약품 서비스에 대한 고객의 증가하는 수요를 충족하는 데 목표를 두고 있습니다.

WuXi Biologics a annoncé des projets visant à renforcer ses capacités de produit pharmaceutique dans son usine de Leverkusen, en Allemagne, avec une nouvelle ligne de remplissage stérile pour les seringues préremplies (PFS). La nouvelle ligne traitera plusieurs tailles de seringues à une cadence pouvant atteindre 400 seringues par minute, avec une capacité annuelle de 17 millions de seringues. Cela s'ajoute à la capacité actuelle de la ligne de remplissage et de lyophilisation, qui est de 10 millions de doses par an. La construction doit commencer récemment, avec un objectif de conformité GMP pour 2026. L'expansion soutient la stratégie d'approvisionnement duale mondiale de WuXi Bio et vise à répondre à la demande croissante des clients pour des services de produits pharmaceutiques.

WuXi Biologics hat Pläne angekündigt, die Arzneimittelproduktionsfähigkeiten an seinem Standort in Leverkusen, Deutschland, mit einer neuen sterilen Abfüllanlage für Fertigspritzen (PFS) zu verbessern. Die neue Linie wird mehrere Spritzgrößen mit einer Geschwindigkeit von bis zu 400 Spritzen pro Minute verarbeiten und eine jährliche Kapazität von 17 Millionen Spritzen erreichen. Dies erweitert die bestehende Kapazität der Abfüll- und Gefriertrocknungsanlage von jährlich 10 Millionen Dosen. Der Bau soll kürzlich beginnen, mit einer angestrebten GMP-Konformität für 2026. Die Erweiterung unterstützt die globale Dual-Sourcing-Strategie von WuXi Bio und zielt darauf ab, der wachsenden Kundennachfrage nach Arzneimittelprodukten gerecht zu werden.

Positive
  • Adding 17 million syringes annual production capacity
  • Expanding manufacturing capabilities with new PFS line
  • Enhancing operational efficiency through optimized facility layout
  • Strengthening global dual sourcing strategy
Negative
  • Significant capital investment required for expansion
  • Extended timeline to GMP compliance (2026)

LEVERKUSEN, Germany, Nov. 13, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that it will enhance its drug product (DP) capabilities at the company's facility in Leverkusen, Germany, with a new sterile filling line for prefilled syringes (PFS) using isolator technology.

Construction of the new line will optimize the design of the Leverkusen facility's manufacturing layout to be more efficient for multi-product CRDMO use. The new line, with its capability to handle multiple syringe sizes (1 ml, 2.25 ml, and 3 ml) at a filling rate of up to 400 syringes per minute, enables flexible GMP production of at least 17 million syringes every year. This will be in addition to the existing sterile filling and freeze-drying line that has an annual capacity of approximately ten million doses. Construction is scheduled to commence recently, with the goal of achieving GMP compliance by 2026.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "The increased capacity in Germany will allow us to continue to meet growing client demand for DP services, especially for prefilled syringes. Such investments further demonstrate our commitment to the Global Dual Sourcing strategy that ensures materials can be sourced and products manufactured at multiple sites within the company's global network. As a trusted partner to global healthcare companies and a significant contributor to the local community, we are dedicated to providing efficient and cost-effective processes that enable our clients to bring breakthrough therapies to patients."

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2024, WuXi Biologics is supporting 742 integrated client projects, including 16 in commercial manufacturing (excluding COVID CMO and non-COVID dormant CMO projects).

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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Cision View original content:https://www.prnewswire.com/news-releases/wuxi-biologics-germany-to-enhance-capabilities-with-new-prefilled-syringes-line-302305043.html

SOURCE WuXi Biologics

FAQ

What is the new production capacity of WuXi Biologics' Leverkusen facility for prefilled syringes?

The new PFS line will have an annual production capacity of 17 million syringes, in addition to the existing 10 million doses from the current filling and freeze-drying line.

When will WuXi Biologics' new PFS line in Germany achieve GMP compliance?

The new prefilled syringe line is scheduled to achieve GMP compliance by 2026.

What syringe sizes will the new WuXi Biologics Germany facility handle?

The new line will handle multiple syringe sizes including 1 ml, 2.25 ml, and 3 ml, with a filling rate of up to 400 syringes per minute.

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