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Stevanato Group, Gerresheimer and SCHOTT Pharma, Announce Strategic Industry “Alliance for RTU”

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Stevanato Group (NYSE: STVN), Gerresheimer AG (MDAX: GXI), and SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP) have formed the 'Alliance for RTU' to promote the adoption of Ready-to-Use (RTU) vials and cartridges in the pharmaceutical industry. This strategic alliance aims to share expertise on high-quality sterile primary packaging with pharmaceutical companies, CMOs, and CDMOs.

The alliance highlights the advantages of RTU configurations over conventional bulk packaging, including reduced operational risks, enhanced flexibility, increased efficiency, and lower total cost of ownership. RTU technology can help streamline processes, increase productivity, and reduce contamination risks while easing EU GMP Annex 1 compliance.

The Alliance for RTU will create an open expert platform to help industry manufacturers learn about the benefits of RTU processes and products, supporting the transition to efficient filling systems for both clinical applications and commercial use.

Stevanato Group (NYSE: STVN), Gerresheimer AG (MDAX: GXI) e SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP) hanno formato l''Alleanza per il RTU' per promuovere l'adozione di fiale e cartucce pronte all'uso (RTU) nell'industria farmaceutica. Questa alleanza strategica mira a condividere competenze sulla produzione di imballaggi primari sterili di alta qualità con le aziende farmaceutiche, i CMO e i CDMO.

L'alleanza sottolinea i vantaggi delle configurazioni RTU rispetto all'imballaggio convenzionale in bulk, tra cui rischi operativi ridotti, maggiore flessibilità, efficienza aumentata e minor costo totale di proprietà. La tecnologia RTU può contribuire a semplificare i processi, aumentare la produttività e ridurre i rischi di contaminazione, facilitando al contempo la conformità all'Allegato 1 delle GMP europee.

L'Alleanza per il RTU creerà una piattaforma esperta aperta per aiutare i produttori del settore a conoscere i vantaggi dei processi e dei prodotti RTU, sostenendo la transizione a sistemi di riempimento efficienti per applicazioni cliniche e uso commerciale.

Stevanato Group (NYSE: STVN), Gerresheimer AG (MDAX: GXI) y SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP) han formado la 'Alianza por el RTU' para promover la adopción de viales y cartuchos listos para usar (RTU) en la industria farmacéutica. Esta alianza estratégica tiene como objetivo compartir experiencia sobre envases primarios estériles de alta calidad con empresas farmacéuticas, CMO y CDMO.

La alianza destaca las ventajas de las configuraciones RTU en comparación con el embalaje convencional a granel, incluyendo riesgos operativos reducidos, mayor flexibilidad, eficiencia aumentada y menor costo total de propiedad. La tecnología RTU puede ayudar a agilizar procesos, aumentar la productividad y reducir los riesgos de contaminación, facilitando al mismo tiempo el cumplimiento del Anexo 1 de las GMP de la UE.

La Alianza por el RTU creará una plataforma experta abierta para ayudar a los fabricantes de la industria a aprender sobre los beneficios de los procesos y productos RTU, apoyando la transición a sistemas de llenado eficientes tanto para aplicaciones clínicas como para uso comercial.

Stevanato Group (NYSE: STVN), Gerresheimer AG (MDAX: GXI), 그리고 SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP)는 제약 산업에서 사용하기 위한 준비가 완료된(RTU) 바이알 및 카트리지의 채택을 촉진하기 위해 'RTU를 위한 동맹'을 결성했습니다. 이 전략적 동맹은 제약 회사, CMO 및 CDMO와 함께 고품질의 멸균 기본 포장에 대한 전문 지식을 공유하는 것을 목표로 합니다.

이 동맹은 전통적인 벌크 포장에 비해 RTU 구성의 장점을 강조하며, 작업 리스크 감소, 유연성 향상, 효율성 증가 및 총 소유비용 절감 등을 포함합니다. RTU 기술은 프로세스를 간소화하고 생산성을 높이며 오염 위험을 줄이고 유럽 GMP 부칙 1 준수를 용이하게 할 수 있습니다.

RTU를 위한 동맹은 산업 제조업체가 RTU 프로세스 및 제품의 이점을 배울 수 있도록 돕는 개방형 전문 플랫폼을 생성하여 임상 응용과 상업적 사용 모두를 위한 효율적인 충전 시스템으로의 전환을 지원할 것입니다.

Stevanato Group (NYSE: STVN), Gerresheimer AG (MDAX: GXI) et SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP) ont formé l''Alliance pour le RTU' pour promouvoir l'adoption de flacons et de cartouches prêts à l'emploi (RTU) dans l'industrie pharmaceutique. Cette alliance stratégique vise à partager son expertise sur l'emballage primaire stérile de haute qualité avec des entreprises pharmaceutiques, des CMO et des CDMO.

L'alliance met en avant les avantages des configurations RTU par rapport à l'emballage en vrac classique, y compris réduction des risques opérationnels, flexibilité accrue, efficacité augmentée et coût total de possession réduit. La technologie RTU peut aider à rationaliser les processus, augmenter la productivité et réduire les risques de contamination tout en facilitant la conformité avec l'Annexe 1 des GMP de l'UE.

L'Alliance pour le RTU créera une plateforme d'experts ouverte pour aider les fabricants de l'industrie à découvrir les avantages des processus et produits RTU, soutenant la transition vers des systèmes de remplissage efficaces pour les applications cliniques et l'utilisation commerciale.

Die Stevanato Group (NYSE: STVN), die Gerresheimer AG (MDAX: GXI) und die SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP) haben die 'Allianz für RTU' gegründet, um die Adoption von gebrauchsfertigen (RTU) Vials und Kartuschen in der Pharmaindustrie zu fördern. Diese strategische Allianz hat das Ziel, Fachwissen über hochwertige sterile Primärverpackungen mit pharmazeutischen Unternehmen, CMO und CDMO zu teilen.

Die Allianz hebt die Vorteile von RTU-Konfigurationen gegenüber herkömmlicher Bulkverpackung hervor, einschließlich geringerer operationeller Risiken, erhöhter Flexibilität, gesteigerter Effizienz und niedrigeren Gesamtkosten des Eigentums. Die RTU-Technologie kann helfen, Prozesse zu straffen, die Produktivität zu erhöhen und Kontaminationsrisiken zu mindern, während sie gleichzeitig die Einhaltung des Anhangs 1 der EU GMP erleichtert.

Die Allianz für RTU wird eine offene Expertenplattform schaffen, um Herstellern der Branche zu helfen, die Vorteile von RTU-Prozessen und -Produkten kennenzulernen und den Übergang zu effizienten Abfüllsystemen für klinische Anwendungen und kommerzielle Nutzung zu unterstützen.

Positive
  • Formation of strategic 'Alliance for RTU' to promote adoption of Ready-to-Use vials and cartridges
  • Potential for reduced operational risks and lower total cost of ownership for pharmaceutical companies
  • Improved efficiency and productivity in pharmaceutical manufacturing processes
  • Enhanced product quality and reduced contamination risks
  • Creation of an open expert platform to support industry transition to RTU solutions
Negative
  • None.

Insights

The formation of the "Alliance for RTU" between Stevanato Group, Gerresheimer and SCHOTT Pharma is a significant development in the pharmaceutical packaging industry. This strategic alliance aims to promote the adoption of Ready-to-Use (RTU) vials and cartridges, which could have far-reaching implications for pharmaceutical manufacturing processes.

Key points to consider:

  • The alliance targets increased operational efficiency and patient safety in pharmaceutical manufacturing.
  • RTU containers offer reduced risks, lower total cost of ownership and improved compliance with EU GMP Annex 1.
  • The move reflects a broader industry trend towards advanced aseptic filling technologies, driven by growing demand for injectable medicines and stricter safety regulations.
  • This collaboration among major players could accelerate the transition from traditional bulk packaging to RTU solutions, potentially reshaping industry standards.

While the immediate financial impact may be , the long-term implications for these companies and the broader pharmaceutical supply chain could be substantial. Investors should monitor how this alliance influences market adoption rates of RTU technologies and the potential for increased market share for the participating companies.

The "Alliance for RTU" represents a pivotal shift in pharmaceutical manufacturing, addressing critical challenges in the industry. RTU vials and cartridges offer several advantages over conventional bulk packaging:

  • Enhanced sterility and reduced contamination risks, important for compliance with stringent regulations like EU GMP Annex 1
  • Improved operational efficiency, potentially leading to significant cost savings for pharmaceutical companies and CMOs
  • Higher quality products with minimized glass particle release and reduced breakage risks
  • Increased flexibility in production processes, particularly beneficial for smaller batch sizes and personalized medicines

This alliance, bringing together three major players in pharmaceutical packaging, signals a strong industry commitment to RTU technology. It could accelerate the adoption of these advanced solutions, particularly among smaller pharmaceutical companies and CMOs who might have been hesitant due to perceived complexities or costs. The initiative to create an open expert platform for RTU industry standards is particularly noteworthy, as it could lead to wider acceptance and potentially new innovations in the field.

  • Market advances adoption of ready-to-use containers
  • Improved operational efficiency in pharmaceutical manufacturing processes
  • Increased patient safety with high-quality sterile primary packaging

PIOMBINO DESE, Italy--(BUSINESS WIRE)-- Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, together with Gerresheimer AG (MDAX: GXI) and SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP), announced today that they have entered into a strategic industry alliance ("Alliance for RTU") to support market adoption of Ready-to-Use (RTU) vials and cartridges.

Stevanato Group, Gerresheimer & SCHOTT Pharma join forces in the 'Alliance for RTU' (Photo: Business Wire)

Stevanato Group, Gerresheimer & SCHOTT Pharma join forces in the 'Alliance for RTU' (Photo: Business Wire)

The Alliance for RTU aims to share with pharmaceutical companies, CMOs and CDMOs expertise and technical knowledge in high-quality sterile primary packaging, specifically ready-to-fill vials and cartridges, highlighting RTU configurations' advantages over conventional bulk packaging.

Reduced risks and lower total cost of ownership

Traditional fill&finish processes present several operational risks and require increased efficiency. By adopting an industrial ready-to-use (RTU) setup, pharmaceutical companies and Contract Manufacturing Organizations (CMOs) can benefit from reduced operational risks, enhanced flexibility and efficiency, and lower waste. RTU technology can help streamline processes, increase productivity, and thus lower total cost of ownership (TCO) while reducing contamination risks and easing EU GMP Annex 1 compliance.

Pharmaceutical companies, CMOs and CDMOs opting for ready-to-use containers also can benefit from higher-quality products, which helps minimize the release of glass particles and risks of breakage or rejection while preserving the drug inside throughout its entire life cycle.

Open expert platform for RTU industry standard

Additionally, the market is driving investment in advanced aseptic filling technologies due to increasing demand for injectable medicines and regulatory pressure to meet safety standards. In this context, the Alliance for RTU aims to create an expert platform open to other industry players to help industry manufacturers learn about the key benefits of RTU processes and products and to better evaluate investments for transitioning to efficient filling systems and meeting their unique needs from clinical applications to widespread commercial use.

“RTU vials and cartridges represent a significant advancement in product quality, offering enhanced reliability and efficiency in pharmaceutical processes. This alliance allows us to highlight further how RTU solutions elevate standards across the industry, ensuring safer and more effective delivery of medications to patients worldwide," said Franco Stevanato, CEO at Stevanato Group.

“The shift towards ready-to-use vials and cartridges reflects a collective industry move to advance quality and efficiency in aseptic filling processes and this alliance shows readiness by expanding capacity and thereby supporting this market trend,” said Andreas Reisse, CEO at SCHOTT Pharma. “Ready-to-use solutions can reduce complexities and better meet the stringent requirements of modern pharmaceutical production.”

"As an industry, we are fully prepared for the transition to RTU vials and cartridges”, said Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. “With recent advancements, RTU processing is now a mature technology which will improve our customers operations in terms of efficiency, cost and time to market."

The Alliance for RTU will be officially presented at the CPHI in Milan on October 8 during a dedicated event at the tradeshow fairground. For more information, visit www.alliance-for-rtu.com.

About Stevanato Group

Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. To learn more, visit: www.stevanatogroup.com.

About Gerresheimer

Gerresheimer is an innovative systems and solutions provider and a global partner to the pharma, biotech, and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, infusion, dropper and syrup bottles, and more. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).

www.gerresheimer.com

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023. Further information at www.schott-pharma.com.

Forward-Looking Statements

This press release may include forward-looking statements. The words “aims”, “”increase”, “lower”, “ is driving”, “increasing”, “create”, “move”, “expanding”, “advance”, “can”, “will”, and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the investments the Company expects to receive, the expansion of manufacturing capacity, the Company’s plans regarding its presence in the U.S. and other markets, business strategies, the Company’s capacity to meet future market demands and support preparedness for future public health emergencies, and results of operations. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.

Media Stevanato Group

media@stevanatogroup.com

Cassie Gonzalez: stevanatoUS@teamlewis.com

Investor Relations Stevanato Group

Lisa Miles: lisa.miles@stevanatogroup.com

Media Gerresheimer AG

Jutta Lorberg

Head of Corporate Communication

T +49 211 6181 264

jutta.lorberg@gerresheimer.com

Investor Relations Gerresheimer AG

Guido Pickert

Vice President Investor Relations

T +49 152 900 14145

gerresheimer.ir@gerresheimer.com

Media SCHOTT Pharma

Joana Kornblum

Tel.: +49 151/29223552

E-Mail: joana.kornblum@schott.com

Investor Relations SCHOTT Pharma

Jasko Terzic, CFA

E-Mail: ir.pharma@schott.com

Source: Stevanato Group

FAQ

What is the 'Alliance for RTU' announced by Stevanato Group (STVN)?

The 'Alliance for RTU' is a strategic industry alliance formed by Stevanato Group (STVN), Gerresheimer AG, and SCHOTT Pharma to support market adoption of Ready-to-Use (RTU) vials and cartridges in the pharmaceutical industry.

What are the benefits of RTU vials and cartridges according to the Stevanato Group (STVN) announcement?

According to the announcement, RTU vials and cartridges offer reduced operational risks, enhanced flexibility, increased efficiency, lower total cost of ownership, streamlined processes, increased productivity, reduced contamination risks, and easier EU GMP Annex 1 compliance.

How will the 'Alliance for RTU' support pharmaceutical companies according to Stevanato Group (STVN)?

The Alliance for RTU will share expertise and technical knowledge in high-quality sterile primary packaging with pharmaceutical companies, CMOs, and CDMOs. It will also create an open expert platform to help industry manufacturers learn about the benefits of RTU processes and products.

When and where will the 'Alliance for RTU' be officially presented by Stevanato Group (STVN)?

The Alliance for RTU will be officially presented at the CPHI in Milan on October 8 during a dedicated event at the tradeshow fairground.

Stevanato Group S.p.A.

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