ワクチン用のバイアルからプレフィルドシリンジへの移行：３つの重要な成功要因

Vaccines, which contain temperature-sensitive substances, require storage temperatures as low as –40°C. Syringes comprise more complex combinations of materials than vials; development must demonstrate their suitability for such extremely cold storage conditions. To develop an optimal process, sponsors should consider working with partners with proven expertise in both materials and fill and finish, encompassing:

• Formulation development
• Screening of syringes and plungers
• Assessment of compatibility of containers with vaccines
• Holding time studies
• Freeze and thaw studies
• Container closure integrity during a temperature excursion
• Gliding and break-loose force temperature dependence
• Shipping studies
• Scalability studies

Patient benefits of prefilled syringes

Benefits of prefilled syringes include:²

• Ability for rapid administration
• Self-administration of chronic disease treatments at home rather than in a hospital
• Lowered risk of microbial and chemical cross-contamination
• Improved dosing accuracy

For process development and optimization, it is helpful to have a single partner that can provide a streamlined transfer from initial development phases through to commercial scale. This enables potential hurdles to large-scale transfer to be addressed from the outset.

For steriles, and for syringes in particular, the regulatory landscape is very challenging. Planning is important from the earliest stage of development to determine the best time to switch from vials to prefilled syringes. This change involves demonstrating the robustness of the vaccine formulation in various containers, and the suitability of the primary packaging components for all approved storage conditions. Recent, up-to-date experience in dealing with local and global regulatory bodies plays a crucial role in the development of a global plan for a vaccine in a prefilled syringe. A typical path is based on a risk/benefit approach. A clear definition of the final target product profile can enable appropriate planning of studies required to make the switch between containers flawless—and avoid unwelcome surprises later in development.

In conclusion, a move from vials to prefilled syringes can lead to many benefits for stakeholders, including patients, health care providers, and drug manufacturers. The three key success factors discussed earlier can ensure that all challenges are addressed as this transition is managed. Together, these provide a complete understanding of the critical parameters that can affect the overall stability of the final presentation in a prefilled syringe—avoiding waste of valuable resources and enabling selection of the best primary packaging for successful commercialization.³