Contract Manufacturing for Drug Delivery Systems - Stevanato Group
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One-stop shop for your Drug Delivery Devices

Partnering with Stevanato Group to manufacture your drug delivery device means streamlining your process and getting on board for a burden-free experience. From the early stages of drug development, we can support biopharma companies in identifying and developing the best container-closure system and drug delivery system, all the way through to commercialization.

Integrating products, technologies and services under a single reference point, Stevanato Group boasts a novel business model as a one-stop-shop. During our 70-year history, we have evolved from a glass processor to an established, all-round supplier to the pharmaceutical industry, enabling our clients to fulfill their mission: delivering safe and effective treatments every day.

 

An Integrated Approach for Your Project

Thanks to our integrated approach, we can harmonize all the different development processes – from the definition phase to the production and global supply of your device.

We assign you a dedicated team and a project manager to oversee the course of the project and keep you informed of the status of each phase.

Our project managers have extensive experience in lifecycle management and are familiar with the regulatory environment:

 

Definition Phase

Bringing your ideas to life, resulting in a product requirement document

Concept Phase

Definition of the proper glass container and container closure system, when needed; elaboration of device concepts and construction of plastic mock-ups.

Development phase

Development, optimization and documentation according to Design History File (DHF) and Device Master File (DMF), mechanical testing, shelf-life studies, risk management, usability studies, regulatory verification, design for manufacturing

Production Phase

Optimization of your products with our extensive plastic injection molding capabilities, from manual to fully automated assembly, synergizing glass and plastic expertise where appropriate

Definition Phase

Bringing your ideas to life, resulting in a product requirement document

Concept Phase

Definition of the proper glass container and container closure system, when needed; elaboration of device concepts and construction of plastic mock-ups.

Development phase

Development, optimization and documentation according to Design History File (DHF) and Device Master File (DMF), mechanical testing, shelf-life studies, risk management, usability studies, regulatory verification, design for manufacturing

Production Phase

Optimization of your products with our extensive plastic injection molding capabilities, from manual to fully automated assembly, synergizing glass and plastic expertise where appropriate

Highest-quality primary packaging for pharmaceutical applications

Glass plays a crucial role in the development of drug delivery devices. By continually perfecting the forming process, we have become a leading producer of high quality, high value, ready-to-use, primary packaging.

EZ-fill® containers are now the reference market standard and are at the core of complex drug delivery systems, whether they are based on customized cartridges, syringes, barrels or micro-vials. They comprise:

  • Bulk glass products, including vials, cartridges, syringes & ampoules
  • EZ-fill® containers: sterilized & ready to fill
  • Full dimensional control & cosmetic inspection
  • Nexa® line, ideally suited for autoinjector and pen injectors; Alba® for biologics

Analytical & testing lab services that lead to world-class products

Over the years, we have amassed an exceptional amount of information about glass containers and delivery solutions: SG Lab is the repository of this knowledge, which ranges from container closure system integrity to specific testing for drug delivery systems, including analytical characterization of drug-device interaction.

Functionality analysis:

  • Gliding, integrity, sterility

Compatibility testing:  

  • Visible & sub-visible particles
  • Extractables & leachables

Combination products testing:

  • Physical phenomena driving technology analysis and math models creation
  • Characterization and correlation between components on sub-assembled parts and primary container
  • Prototype device performance analysis

Experienced Regulatory Affairs team, providing guidance on your filing strategies

Ensuring safe and user-friendly devices is indispensable when bringing any healthcare product to market.
Our knowledge, powered by a wide network of external experts, helps biopharma companies navigate through the current regulatory requirements, assisting them with registration strategies, globally.

We can guide through different regulatory pathway in accordance with EU and FDA regulations. We can also support the registration of combination products by providing information to the Applicant by Drug Master Files DMF type III and EU files. We are also highly qualified to assist the client during all phases of product development, through our experience with GMP, 21 CFR 210/211, 21 CFR 820 and Combination Products 21 CFR Part 4.

Precision plastic molding, tool design & maintenance

In addition to glass components, Stevanato Group has extended its portfolio of injection molded plastics, boosting its in-house expertise in tool design and maintenance. All products are accurately measured and visually inspected to meet the most stringent specifications:

  • Expert tool designers in design for manufacturing
  • 150+ injection molding machines available at 3 locations in the US and Germany
  • 13,500 m2 of GMP & cleanroom areas for assembly & packaging in Germany and the US
  • Class 7 & 8 cleanroom production
  • Fully-automatic, vacuum-fed material handling system

Flexible & modular assembly options from small scale to mass production

Thanks to our industrialization capabilities, sub- and final assembly modules, and flexible packaging lines, we can develop scalable solutions, such as pen injectors, automatic injectors, inhalers, wearables, and accessories, like vial adapters.

  • Manual, semi-automatic & fully-automatic assembly capabilities
  • Equipment designed & manufactured in house at our facility in Denmark to be modular and easy to scale up, from table top modules up to mass production
  • Flexible modules allowing to process multiple devices on the same machine, including different packaging and labelling configurations

 

Stevanato Group can support in the following areas:

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Wearables

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Inhalers

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Pen injectors

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Auto-injectors

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Accessories

Discover our Product Portfolio

EZLINK
Vial-to-syringe adapter to reconstitute solid form drugs with any standard luer-lock diluent prefilled syringe
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ICOcap
Capsule-based dry-powder inhaler for asthma and COPD
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Cartridge-based Wearable Device
Our proprietary wearable device devised to maximize patient’s comfort
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Stevanato Group: Your contract manufacturer bringing ideas to life 

We can develop drug delivery devices in partnership with our customers, relying on third-party IP or through the development of proprietary IP, contributing to improving your manufacturing readiness and time-to-market.

 

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