Diabetes is a serious and chronic disease that has been steadily increasing over the past few decades. Globally, an estimated 422 million adults were living with diabetes in 2014, compared to 108 million in 1980. This reflects an increase in associated risk factors such as being overweight or obese. Recently, diabetes prevalence has risen faster in low- and middle-income countries than that of higher-income countries*.
Diabetes can be managed and controlled with a number of injectable treatments available on the market, the most common ones are insulin, GLP-1, and glucagon. Over the years, anti-diabetic medications have been one of the focuses for Ompi’s research and development.
For decades, Stevanato Group has been working to provide the best glass primary packaging to pharmaceutical companies leading in the insulin market: nowadays Stevanato has become the first world’s largest manufacturer of glass cartridges for insulin dedicated to diabetes treatment.
Insulin, GLP-1, and glucagon are drugs that require high reliability, a steady supply chain, avoiding stops in line to increase production. Furthermore, the integration with pen-injectors or auto-injectors is another important aspect to consider.
*Source: 2016 Global Report on Diabetes, World Health Organization
Stevanato Group’s leadership in the insulin field is not limited only to glass containers, but also to the engineering aspects of the glass forming, automatic visual inspection, assembling and final packaging.
Keeping in mind the real needs of customers and patients, Stevanato Group devised Nexa, a top-of-the-range glass primary packaging line, available both for cartridges and for vials.
Nexa cartridges boast an optimized yield and manufacturing efficiency during the industrial life of the drugs reducing the risk of damages that can cause glass breakage during the filling process.
Cartridges are available also in the EZ-fill® configuration, a fully integrated ready-to-use solution for the aseptic manufacturing designed to increase quality (no-glass-to-glass contact) and to reduce the entry barrier linked to the increase in Fill & Finish capacity or in a new plant opening.
Moreover, EZ-fill® can be the ideal solution to reduce both the initial investment and running cost (personnel and utilities, footprint) allowing pharmaceutical companies to minimize the business risk and reach profitability faster.
Global biologic sales are expected to grow from a $161 billion in 2014 to $287 billion by 2020 with an annual estimated growth of 10.1%*. Biotech drugs, especially monoclonal antibodies (mAbs) and recombinant proteins, allowed the pharmaceutical industry to treat very critical diseases that were listed as incurable in the past. Biotech drugs are very challenging to stabilize and administrate, especially in a syringe or a drug-delivery device due to their complexity, sensitivity, and viscosity.
One reason behind this escalated growth can be attributed to the progressive switch from blockbuster medicine to personalized treatments and to the conversion from hospitalized patients to outpatients - especially for those who suffer from a chronic disease, which requires the broad application of auto-injectors and wearable devices.
These challenges require a new generation of glass containers that enable a perfect functionality to drug delivery systems, thus ensuring reliability and patient safety.
*Source: Large Volume Wearable Injectors 2014-2025 (Roots Analysis)
With this in mind, Stevanato Group developed novel glass primary packaging that guarantees better chemical, cosmetic and mechanical performance and is perfectly suitable for the new generation of drugs taking into consideration the need to reduce protein aggregation, the Extractables & Leachables level, and the delamination issue.
Alba is a turning point in the development of parenteral primary packaging, representing the best-in-class solution for biologics and ophthalmic drugs. The reduced variability of materials in contact with the drug throughout its life-cycle makes the Alba platform a perfect solution to de-risking the development process, saving on costs and securing a fast introduction to the market.
The drastic reduction of silicone oil particles and the extremely low-propensity to delaminate addresses some of the key requirements of protein-based drugs; thus helping them to remain compliant with the latest guidelines coming from regulatory bodies.
Along with Alba, Ompi has a top-of-the-range product line in glass primary packaging called Nexa.
Nexa is specifically designed for high-value drug products, it ensures excellent mechanical resistance up to three times higher than a standard container with superior cosmetic quality. The quality is guaranteed by a 100% improved camera inspection on the body and on the container closure in addition to characterization studies on silicone distribution.
The Nexa syringe features an improved auto-injector compatibility with its restricted tolerances on the syringe’s flange and shoulders, a superior gliding performance due to an optimized silicone oil distribution inside the barrel and a reduced tungsten pp/b.
A vaccine is a biological formulation that improves the immunity from a specific disease. A vaccine typically contains an agent that resembles a disease-causing microorganism. Often the agent is derived from weakened or killed forms of the microbe, its toxins or one of its surface proteins. The vaccine simulates the body's immune system to recognize the agent as foreign, destroys it, and "remembers" it so that the immune system can more easily recognize and destroy any of these microorganisms that it may later encounter.
Vaccines have numerous fields of application: from flu and travel prophylaxis to pediatrics, and recently for therapeutic applications.
Thanks to Ompi’s proven expertise as a glass manufacturer, Stevanato Group continuously works in collaboration with clients, contributing to the diffusion of vaccines all around the world and helping billions of people every day.
Stevanato Group has always been active in the vaccines field, providing advanced syringes and vials - both for liquid and lyophilized drugs, in bulk or sterile configuration - suitable for high-speed, high-volume production and with the goal of providing support and dependability to the pharmaceutical industry.
Stevanato Group containers, in fact, are the ideal solution to minimize breakages during filling and transportation, guaranteeing excellent cosmetic quality to avoid false-reject and to ensure a seamless and efficient production.
EZ-fill®, thanks to its ready-to-fill format, leverages the commonalities between the different container fill-finish processes by using a common multi-product line.
EZ-fill® allows pharmaceutical companies to outsource their non-core activities, have a lower footprint, and reduce costs related to personnel and utilities.
EZ-fill® is the perfect solution to be managed during clinical trials and the industrialization phase, both for syringes and vials.
After an extensive investigation on the chemical performance of the inner surface of vials and on the critical glass forming process parameters that influence the final delamination propensity of vials, Ompi offers LDP (Low Delamination Propensity) Vials are dedicated to high-speed and high-volume production.
LDP Vials are extremely resistant and particularly suitable for aggressive compounds ensurng consistent chemical performance and no degradation of the inner glass surface, both for bulk configuration and after the EZ-fill® process.
They are produced with Type I Borosilicate glass without any coating applied;
Low-molecular-weight heparins (LMWHs), used as anticoagulants for the prophylaxis of deep venous thrombosis (DVT) and in the inpatient treatment of DVT and pulmonary embolism (PE), are one of the key applications for prefilled syringes.
Their extensive use associated with patients undergoing surgeries like abdominal surgery, hip-replacement surgery, knee-replacement surgery is increasing in both mature markets and developing countries.
Through the years, Stevanato Group has been very active in Antithrombotic and Anticoagulant research, becoming one of the key partners for pharmaceutical companies, not only for glass syringes but also for safety systems, machinery and technical equipment, such as automatic visual inspection and final packaging systems.
Stevanato Group is proud to support the growth of this important endeavor to increase the safety of the patient and the growth of their pharmaceutical partners worldwide.
Stevanato Group, with its proven expertise, can guarantee:
Fina syringes are the preferred solution for high-speed, high-volume production.
In the case of anticoagulants and antithrombotic drugs, Fina ensures operational efficiency thanks to tight dimensional tolerances, high cosmetic quality, and high mechanical resistance.
Fina syringes are highly customizable according to customer’s needs: they can be produced into a wide range of sizes, components, treatments, and secondary packaging.