Streamlining biologics and biosimilars drug development process through a single source

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The increasing number of complex and sensitive biologics and the administration shift from hospitals to patients' homes are two of today’s main biopharmaceutical industry challenges. Complex drugs and self-administration require an appropriate primary packaging selection from the beginning of the bio drug development process. In this article, you will learn how Stevanato Group can support biopharma companies in the container closure system choice leveraging its 70-year expertise in glass primary packaging, up to the integration into drug delivery systems, backed up by solid characterization analysis.

The rising number of biotech drugs poses manufacturing challenges and requires special attention to different aspects of the drug development process. Biologic drugs have complex, sensitive, and viscous compounds that are particularly difficult to stabilize and administrate, especially in the syringe or delivery device configuration.

Secondly, the shift of administration from the skilled care environment of a hospital or a clinic to home healthcare is now also in front of mind when selecting a primary packaging system. Medications for some chronic diseases (osteoporosis, rheumatoid arthritis, and hypercholesterolemia, for instance) and a wide variety of biological preparations are being developed so they can be administered by either the patient -themselves or a home-healthcare worker. Although this helps to drive down the cost of implementation of these drugs, it forces drug companies to make clear choices regarding the primary container.

In the past, systems may have evolved from a vial to an auto-injector with time. However, drugs are now being developed directly into prefillable syringes to meet the increasing homecare demand and to cut further costs out of the healthcare system.

Driven by macro trends in the industry, Stevanato Group worked to develop novel glass primary packaging that ensures better chemical, cosmetic and mechanical performance suitable for the next generation of drugs. Moreover, through its comprehensive range of products, technologies, and services, Stevanato Group has the capability to support pharmaceutical companies in taking their drug product from development to launch. This can be a significant advantage for smaller biotech firms who don't have the internal capacity to oversee various aspects of the project and coordinate multiple suppliers.

The selection of the appropriate primary container packaging for an injectable drug product is one of the most crucial considerations in the drug development process. The wrong choice can cost significant time and resources later in the process.

Sensitivity has always been a problem for the pharmaceutical industry and is becoming even more so now that more and more drugs are biologics and highly concentrated. By some estimates, 20-30% of drug formulations now have sensitivity issues, reacting to one or more elements of their primary packaging and lose their stability.

The problem can be caused by several means, notably: silicone oil sensitivity; the interaction between the drug and the surface of the primary container, leading to protein aggregation; the particles generated by the rubber in the closure system; and surface delamination, especially in glass vials.

SG Alba EZ-fill®: The breakthrough solution for biologics

To address these issues, Stevanato Group has developed the SG Alba® EZ-fill® product line that includes ready-to-fill glass vials, cartridges, and syringes with similar chemical and mechanical characteristics. They act in multiple ways to prevent the problems associated with sensitive drug formulations.

First, all SG Alba® EZ-fill® products have an internal coating, based on the standard silicone oil, Dow Corning 360, which is cross-linked to form a chemical bond with the surface, ensuring a drastic reduction of particle levels caused by silicone migration during container storage. In addition, the coating creates a barrier between the drug and the glass that makes it possible to reduce inorganic extractables compared to a standard container significantly.

The strong chemical bond also leads to better functional performance over time, i.e., gliding and break-loose force. With vials, for which the lubrication aspects are not relevant, the main added value of the SG Alba® EZ-fill® coating is its barrier effect against aggressive drugs, preventing delamination from occurring. When developing SG Alba® EZ-fill®, Stevanato Group also worked closely with rubber manufacturers because around 50% of particles are usually generated by the interaction between the rubber components and the drug. The collaboration focused on developing the lowest particle generation while ensuring that the same materials were available for all the container formats.

Considering all of these variables typically exacerbated by biologics, SG Alba® EZ-fill® helps to de-risk the drug development process, preventing issues that can heavily impact cost and speed to market.

Stevanato Group US Technology Excellence Center

To avoid unnecessary delays, drug developers should work with a specialist partner who can guide them on one of the most critical decisions in their drug development program: choosing the right primary container. It is important that this decision considers requirements from early-stage formulations through to future integration into delivery devices.

For Stevanato Group, the recent opening of a Technology Excellence Center in the US represents the culmination of its leading experience in glass primary packaging – and makes full use of the thorough understanding of container closure systems and drug interactions gained during that time.

Located in Boston, Massachusetts, the US TEC acknowledges the challenges faced by today’s biopharmaceutical developers, who often work with complex, unstable, but very promising compounds. These innovative drug products are precious – both for the companies who develop them and for patients suffering from chronic and severe diseases – and their primary packaging demands deeper consideration, especially when integrated into a drug delivery device.

US TEC will play a crucial role for the small/medium biopharma companies that are willing to outsource analytical investigation, ensuring a two-fold level of compatibility: drug and container closure system, and container closure system with drug delivery device.

Integrated solution for the biopharma industry

For compatibility with drug delivery devices, Stevanato Group has first-hand experience in designing and manufacturing drug delivery systems and understands the challenges of integrating primary packaging containers into delivery devices. Whether it is for pen injectors, such as the SG Alina® disposable pen injector, or whether it is for on-body injectors, such as the SG EZ-Be Pod® wearable, or spring-based auto-injectors, such as the Maverick emergency-use auto-injector, compatibility is of utmost importance. The company has a wide range of expertise in testing and characterization of glass containers deployed in delivery systems, stemming from more than 70 years of supporting pharmaceutical companies with their device development programs, and now more recently, from designing and developing Stevanato Groups’ own proprietary portfolio. The Group has amassed an exceptional amount of dimensional, material, and functional data on glass containers and how those glass containers interact with drug delivery devices. Through its comprehensive range of products, technologies, and services, it can support biopharmaceutical companies in taking their drug product from the early phase to the market launch. Besides end-to-end contract manufacturing services, customers can now access a wide array of compendial services that integrate laboratory expertise and engineering competencies, including analytical services related to container closure systems and characterization and optimization related to the integration of glass primary packaging  into drug delivery devices.

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