Syringes for Clinical Trials

Today’s pharmaceutical and biotechnology companies are under pressure to remain competitive. To do so, they require innovative approaches to manage drug development, particularly early development work. Any competitive advantage in the development process is highly prized – and one approach is to begin the development of the compound in a prefilled syringe earlier in the process, rather than later.

Traditionally, biopharmaceutical companies have almost exclusively used vials in drug development. There are good reasons for this: vials are “well-known” and the initial set-up work is far simpler than for syringe development. Vials also make sense for dose-ranging studies. Thus, given the high cost of drug development, avoiding added costs and complexity in the early stages is a logical choice.

Recently, however, more progressive companies have looked beyond the traditional methods of drug delivery in clinical phases, generating strong growth in the global prefilled syringe market. This is expected to continue, given the increasing emphasis on biologic drugs and other compounds suited to syringes. The trend is also affected by the greater patient-friendliness (especially in cases of caregiver administration) at both the clinical trial and market stage. Companies are realizing that a user-friendly system may enhance the appeal of a trial, making it easier to recruit both patients and medical clinics. Prefilled syringes also contribute to patient compliance and consistency.

There is a further benefit: companies that start syringe development earlier, in full or in parallel with vial development, can cut transition time by as much as 18 months. This shift in planning and execution can ensure an immediate start with the advanced primary packaging device, and can result in a fast and flawless market entry to generate an earlier return on investment. With more and more biologics competing in the same therapeutic space, launching directly in a syringe can differentiate the product from the competition, offering an advantage that other companies will find difficult to beat.

Partnering with a Contract Development and Manufacturing Organization can also make it easier and faster to execute syringe development earlier in the development process. A strong partner, equipped with the necessary experience in this field can help design a robust development process that meets the compounds specific requirements, and mirrors commercial production for a smooth scale-up to subsequent large-scale production from the very start.

 

Paul Nelles Vice President Vetter Pharma-Fertigung GmbH & Co. KG’Ravensburg, Germany

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