The company announced that the two new solutions 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).
The company says when a context where reducing time-to-market is key, its new EZ-fill Kit offers fast access to an adaptable 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.
New advanced biopharmaceutical products
“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.
The 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 is expected to be available commercially beginning in the second quarter of 2024.
Additionally, the company says in order to better support customers, it has introduced a non-GMP laboratory filling and finishing service at its TEC in Boston, USA, and Piombino Dese, Italy. This new service, it says, 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.
Helping raise pharmaceutical manufacturing standards
Bertacchini added: “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.”
Founded in 1949, the group is also active in the glass tube forming technology and inspection systems sector. The Group is the first worldwide producer of insulin cartridges for diabetes treatment and design and production of machinery for glass tubing converting.
Nuova Ompi, the first company of the Group, was founded in Venice in 1949 by Giovanni Stevanato, father of the actual president Sergio Stevanato. In 1959 the company moved to its current location in Italy. A second company (SPAMI) was established in 1971, specialized in the design and construction of high-speed precision machines and complete lines for the production and control of glass tube containers for pharmaceutical use.