Five minutes at CPhI worldwide with …
Chemistry Today/ Pharma Horizon: You just presented a solution to glass delamination in vials. Can you tell us about the technology behind this?
Mauro Stocchi: Ompi launched LDP Vials (with a Low Delamination Propensity) using an optimized forming process with low heating that minimizes the surface inhomogeneity formation. It is the result of 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. Furthermore, LDP vials are rinsed with water after forming to remove eventual residuals and improve the surface homogeneity before annealing.
They are produced with Type I Borosilicate glass without the application of any coating, thus ensuring no need to re-file the drugs to Official Authorities.
Besides bulk configuration, LDP Vials are available also in a ready-to-fill configuration. We have a full range portfolio of Ompi EZ-fill® vials that ensure consistent chemical performance and no degradation of the inner glass surface after containers are washed and depyrogenated.
CT/PH: What other innovations are you bringing on the market now?
MS: Currently Ompi is developing Alba which is a turning point in the development of parenteral primary packaging.
Alba containers, with their special silicone coating, will radically set a new standard and contribute to reducing the impact of two main problems: delamination and silicone particles presence. Thanks to the stronger link of silicone to the glass, the delamination risk is reduced and the compatibility with the most sensitive drugs, such the ones for ophthalmic use, is improved. All Alba containers will always expose the same surface to the drug, thus facilitating the shift from a container to another during the drug development phases.
Besides Alba, Ompi has a top-of-the-range product line in glass primary packaging called Nexa.
The Nexa line is specifically dedicated to biological and high-value drug products ensuring excellent mechanical resistance three times higher than a standard container and superior cosmetic quality.
Nexa containers’ performance are achieved thanks to a specific manufacturing process with no glass-to-glass contact and reduced glass-to-metal contact. In addition, their quality is certified by a 100% camera inspection of the most important parameters, such as silicone distribution and closure.
CT/PH: Is the rise in biologicals a challenge for pharma packaging?
MS: It sure is. The rising number of biotech drugs has placed pressure on manufactures; they must pay attention to new different aspects.
Global biologic sales are expected to grow from a $161B in 2014 to $287B by 2020 with an annual estimated growth of 10.1%.
Biologic drugs have complex, sensitive and viscous compounds that are particularly difficult to stabilize and administrate especially in the syringe or device configuration.
With this in mind, we’re developing novel glass primary packaging that ensure better chemical, cosmetic and mechanical performance suitable for the new generation of drugs.
Secondly, the progressive conversion from hospitalized patients to outpatients, especially for those who suffer from a chronic disease, requires a new generation of glass containers that enable a perfect functionality to drug delivery systems such as auto-injectors and wearable device, thus ensuring reliability and patient safety.
As a reliable partner and glass expert for its clients, Stevanato Group provides consultancy services to the pharmaceutical companies in terms of selection of the best container for new complex drugs based, for instance, on monoclonal antibodies or recombinants proteins.
CT/PH: What different demands do you see for packaging solutions in different markets, such as developed vs developing countries
MS: There is a strong differentiation between developed countries and developing countries in terms of their demands for packaging solutions.
Developed countries such the USA, Europe, Japan and South Korea are focusing their pharmaceutical research on new high-value biologic therapies that are widely used for the prevention and the treatment of a range of chronic diseases, such as cancers, CVDs, autoimmune diseases, rheumatoid arthritis, growth hormone deficiency, hematological diseases, and infectious diseases.
As mentioned before, these therapies are extremely challenging from the primary packaging point of view: we are talking about larger doses, higher viscosity and complex and sensible compounds that can often be administrated through drug delivery systems such as wearables or auto-injectors, which rely on highly engineered glass cartridges or syringes.
As packaging producers, we face three challenges. The first is to guarantee drug stability in the glass containers throughout its lifecycle, from the developing process – usually carried out using glass vials – to the commercialization of the pharmaceutical product.
The second is to ensure the best usability: we are referring to a human-centric design, which bring to manufacture containers that are easily manageable for the end-users and the caregivers, whether inserted into a device or not.
The third and the most important challenge, which is linked to the previous two, is to guarantee the patient’s safety: this means to provide pharmaceutical companies containers with the best mechanical and cosmetic performance, allowing a thorough cosmetic inspection and avoiding the risk of breakage from the manufacturing process up to the point of administration.
Amongst developing countries, markets have a different degree of maturity, but in general, there is an increasing demand for drugs. One of the fast-growing markets is certainly China, which seems strongly determined to enter into Western markets. Like other developing countries, China is looking for glass primary packaging partners with sound expertise that can accelerate their market entry, reducing business risk, and most of all meet US and EU standards. In a case like this, our role is to provide our know-how in glass and our strong knowledge in the regulatory area to offer the best suited solution for their needs.
CT/PH: There are more and elder people in the world – what role packaging plays in the health care of elderly and dementia patients?
MS: An aging population presents unique challenges and opportunities for the medical and pharmaceutical industry. Certain diseases are more prevalent in elderly people; this means that treatment patterns and effectiveness may differ substantially. Moreover, the administration of parenteral drugs for those who may have reduced mobility or are not familiar with technological devices can be important aspects to consider.
Stevanato Group, besides providing Ompi’s advanced range of glass primary packaging, is working side by side with pharmaceutical companies striving to make life simpler for patients. In the above mentioned transition from hospitalized patients to outpatients we provide them with customized and easy to use delivery containers that are used in more convenient and less invasive devices for the administration of therapies, ensuring better patient adherence.
CT/PH: What further trends you see in pharma packaging?
MS: The most successful pharmaceutical companies are moving away from a traditional, top-down model towards a flexible approach that offers personalized, safe and effective treatments, often based on monoclonal antibodies.
This transformation towards flexibility involves production in small batches and therefore the need to reach economic efficiency by cutting non-core activities. Ompi’s EZ-fill range of ready-to-fill containers was specifically designed to allow pharmaceutical companies to focus on their core activities, lower their footprint and reduce their total cost related to personnel and utilities.
From one side I see the small biotech companies and the big pharma companies in established markets such as USA or Europe looking for solutions able to increase the final drug delivery performance while reducing their total cost of ownership. On the other side, the players that are building new production sites in developing countries are looking for quality and cost competitive containers. In an effort to achieve process efficiency both for extremely expensive therapies and for common therapies, the pharmaceutical market is looking for solutions that help it minimize drugs waste and preserve drug integrity from container’s breakages, both during production and transport.
Ompi EZ-fill is the ideal solution for either small batches, initially at the clinical trials stage, or for industrial production. Over the years, its proven advantages have led this processing technology to be adopted as a standard by various glass primary packaging manufacturers. Pharmaceutical customers and biotech companies can benefit from an easy, flexible and streamlined process as they can immediately fill the ready to use vials or cartridges, ultimately reducing their total cost of ownership.