21. October 2014
More than half of all drug candidates in development today are biotech-based drugs and are generally only administered by injection. Prefilled syringe (PFS) usage in particular continues to grow due to increased demand by both patients and health care workers for an easy, safe, and accurate (correct dosage) method to administer injectable drugs. Self-administration of injectable drugs is further increasing the use of PFSs and autoinjectors.
This creates a set of challenges for the medical community, including safety, design, cost, patient comfort and adherence, accuracy, and regulatory compliance. These challenges and more sparked a number of conversations at the 2014 PDA Universe of Prefilled Syringes and Injection Devices conference.
Yet the keynote session, moderated by Adalberto Ramirez, the Vice President of Quality at Amgen, Inc., struck a note of optimism. The discussion focused on why, despite all of the challenges, innovation in technology and components for drug manufacturing and packaging will deliver better medical care and improve patient outcomes.
This is perhaps best illustrated by the advancements in PFSs that better protect patient safety and the strengthening partnerships between drug and packaging manufacturers.
How to build a safer PFS
Drug developers and PFS manufacturers are met with several challenges as PFSs grow in popularity, chief among them being patient safety. Together, manufacturers must ensure the packaging does not interact with the drug, which could impact the efficacy or, in a worst-case scenario, have adverse effects on a patient’s health.
Pharmaceutical companies must demonstrate the drug stability with various components of a PFS throughout shelf life. Drugs in a PFS come in contact with more materials and components than in a vial or ampoule. This could include the needle, the adhesive that bonds the needle and glass, silicone oil, and rubber components, creating more opportunities for interactions. For these reasons, manufacturers are designing new PFSs with higher standards that allow patients and health care workers to more effectively and safely administer lifesaving drugs.
Using technology to improve health outcomes
Packaging manufacturers like SCHOTT have created new PFS designs to meet the growing demand for systems that offer improved stability of sensitive drugs, and safer and more comfortable injections. In the syriQ InJentle syringe, for example, the unique design separates the drug and needle to prevent interaction between the two. The special design of the syriQ InJentle glass barrel does not require the use of tungsten pins during the glass forming process, making the PFS completely tungsten-free.
In addition, SCHOTT works closely with drug companies to understand and offer the proper needle designs for various applications. A number of factors, including material, gauge, and design of the needle, are determined by the drug, route of drug administration, and application. For example, the treatment of patients with age-related macular degeneration can involve injections into the eye, requiring a specific needle to ensure patient comfort. I presented on this topic at PDA Universe with Gautam Shetty, Ph.D., the Director and General Manager of Advanced Drug Delivery Systems at Unilife, and detailed how a PFS can ensure safety, efficacy, and compliance for these intravitreal injections.
Stronger focus on partnerships
The growing demand for PFSs and added safety considerations have made packaging a more integral part in the development of a new drug, and more manufacturers are treating packaging suppliers as partners. Christian Helbig, the Head of Global Business Development for Syringes at SCHOTT, moderated a session on this topic during the PDA conference, noting that when drug developers and packaging manufacturers work together early in the development process, they can reduce the drug’s approval process and time to market.
While the PDA Universe conference shed light on a number of challenges remaining in the PFS market, many solutions were also evident. Advanced PFS technology has improved the stability of sensitive drugs, enabled safer and more comfortable injections, and achieved better patient outcomes.
As demand for PFSs continues to grow, a pharmaceutical company that partners with a syringe manufacturer from day one can ensure that the primary packaging is ideal for its drug. A close partnership between drug producers and packaging manufacturers provides a safer, easier, and more effective treatment for patients.