Stevanato Group Launches EZ-fill® Kit and Laboratory Fill and Finish Service to Support Small Batch Drug Development and Commercialization

Rhea-AI Summary

Stevanato Group S.p.A. (NYSE: STVN) has introduced two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers. The EZ-fill® Kit provides fast access to a customizable and versatile solution for efficiently filling small batches with high-quality injectable formulations. The surge in biopharmaceuticals treating various diseases signals significant growth potential for pharmaceutical companies. The kit brings enhanced levels of quality and safety to patients and is expected to be available commercially beginning in the second quarter of 2024.

Insights

Market Research Analyst

The introduction of the EZ-fill® Kit by Stevanato Group represents a strategic move to capitalize on the growing demand for efficient small batch production in the biopharmaceutical industry. With over 60% of the 21,000 drugs in development being injectables and 44% of these being biopharmaceuticals, there is a clear market need for solutions that can expedite the drug development process while ensuring high-quality standards. The modular nature of the EZ-fill® Kit allows for a high degree of customization, which is particularly advantageous for companies during the clinical trial phase or when producing commercial batches where flexibility and speed are essential.

Furthermore, the introduction of the non-GMP laboratory fill and finish service at Stevanato Group's Technology Excellence Centers could significantly enhance the company's value proposition. By allowing customers to test and refine their container selection and fill-and-finish processes early on, Stevanato Group is positioning itself as not just a supplier, but as a partner in the development process, potentially leading to increased customer loyalty and a stronger competitive edge.

Medical Research Analyst

The announcement of Stevanato Group's EZ-fill® Kit and non-GMP laboratory service underscores the importance of innovation in drug delivery systems for the biopharmaceutical sector. The ability to quickly and reliably fill small batches of high-quality injectables is critical for advancing clinical trials and bringing new treatments to market. This is especially pertinent for biopharmaceuticals, which often target complex and rare diseases requiring specialized delivery mechanisms.

The EZ-fill® Kit's ready-to-use, pre-sterilized containers could reduce contamination risks and enhance patient safety, addressing a key concern in the administration of injectable drugs. Additionally, the ability to ship these kits via courier suggests a logistical efficiency that could streamline the supply chain for pharmaceutical companies, potentially reducing costs and improving the rate at which new drugs are made available to patients.

Financial Analyst

From a financial perspective, Stevanato Group's launch of the EZ-fill® Kit and fill-and-finish services could have significant implications for the company's revenue streams. By tapping into the robust pipeline of injectable drugs in development, the company is well-positioned to benefit from the industry's growth trajectory. The modular and customizable nature of the EZ-fill® Kit aligns with the industry's shift towards personalized medicine and could command premium pricing due to its added value in the drug development cycle.

The announcement also signals potential future growth in Stevanato Group's service offerings, which may attract new clients and deepen relationships with existing ones. As the company prepares for the commercial availability of the EZ-fill® Kit in the second quarter of 2024, investors should monitor adoption rates and customer feedback, as these will be critical indicators of the product's impact on the company's financial health.

New developments in the biopharmaceutical field fuel a need for highly scalable and flexible solutions

PIOMBINO DESE, Italy--(BUSINESS WIRE)-- Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, unveiled today two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC).

EZ-fill® Kit by Stevanato Group (Photo: Business Wire)

In a context where reducing time-to-market is key, Stevanato Group’s new EZ-fill® Kit offers fast access to a customizable and versatile solution to pharma and biotech companies needing to efficiently fill small batches with high-quality injectable formulations during clinical trials or commercial phases.

The surge the industry has seen in biopharmaceuticals treating various diseases in several therapeutical areas may signal a significant growth potential for pharmaceutical companies. Injectables, comprising more than 60% of the over 21,000 drugs currently in development, of which 44% are biopharmaceuticals, require high-performance primary packaging and delivery technologies for proper storage and administration.

Stevanato Group’s EZ-fill® Kit builds on its existing ready-to-use platform of pre-sterilized containment solutions – vials, cartridges, and syringes – allowing customers to effectively screen different primary packaging in combination with drug products. The kit will be available as a modular box made up of glass ready-to-use drug containers and add-on components on request, shipped by courier. As a result, the platform can bring enhanced levels of quality and safety to patients across the entire drug life cycle and improve the rate at which new drugs enter the market. EZ-fill® Kit will be presented at Pharmapack and is expected to be available commercially beginning in the second quarter of 2024.

Additionally, to better support customers, Stevanato Group has introduced a non-GMP laboratory filling and finishing service at its Technology Excellence Centers (TEC) in Boston, USA, and Piombino Dese, Italy. This new service allows customers to assess and identify the possible effects of the fill-and-finish process on their product performance as early as the container selection stage, thus de-risking processes and enhancing development and commercialization strategy.

“In the race to bring new advanced biopharmaceutical products to market and to patients, Stevanato Group is tackling the challenge of supporting customers with flexible drug containment and filling solutions in a timely manner," says Fabio Bertacchini, Senior Director EZ-fill® Vials & Cartridges at Stevanato Group. "Stevanato Group remains focused on developing new offerings that can help raise pharmaceutical manufacturing standards. By leveraging the expertise provided by our global TEC Centers, we aim to support customers' innovation, helping them face tests and de-risking processes and making right-the-first-time choices throughout their drug development journey.”

For more information on Stevanato Group’s EZ-fill® Kit, visit www.stevanatogroup.com and visit us at Pharmapack booth F46.

* Pharmaprojects 2023 | Pharma R&D Annual Review 2023.

Forward-Looking Statements

This press release may include forward-looking statements. The words "may,” “potential,” “offers,” “will be,” “can,” “is expected,” “remains,” “aim,” 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, investments the Company expects to make, the expansion of manufacturing capacity, the Company’s plans regarding its presence in the U.S., 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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240124439132/en/

Media relations:

media@stevanatogroup.com

Investor relations:

Lisa Miles: lisa.miles@stevanatogroup.com

Team Lewis for Stevanato Group:

Cassie Gonzales: stevanatoUS@teamlewis.com

Nicolò Marcon, Arianna Cusolito: stevanatoita@teamlewis.com

Source: Stevanato Group S.p.A.

FAQ

What new offerings has Stevanato Group introduced for pharmaceutical manufacturing?

Stevanato Group has introduced the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers.

What is the purpose of the EZ-fill® Kit?

The EZ-fill® Kit provides fast access to a customizable and versatile solution for efficiently filling small batches with high-quality injectable formulations.

What is the expected availability of the EZ-fill® Kit?

The EZ-fill® Kit is expected to be available commercially beginning in the second quarter of 2024.

Where can more information on Stevanato Group’s EZ-fill® Kit be found?

More information on Stevanato Group’s EZ-fill® Kit can be found at www.stevanatogroup.com and at Pharmapack booth F46.