Intravitreal injection is a medical procedure to deliver medication directly into the vitreous cavity, the space in the back of the eye. The number of such injections has been steadily increasing due to the growing patient population with ocular diseases, as well as the wider availability of intravitreal injection drugs, including innovative biopharmaceuticals and their biosimilars. Prefilled syringes (PFS) are now widely used for intravitreal injections, offering multiple advantages such as ease of use, reduced overfill, and the potential to lower the risk of endophthalmitis.
One of the key challenges in developing and manufacturing intravitreal PFS is effective particle management. Strict compendial requirements, such as USP <790> and USP <789>, define clear limits. Addressing these requirements is not only a matter of regulatory compliance but also essential for ensuring patient safety and consistent product quality.
To tackle this challenge, particle management in PFS products requires a holistic approach. Strong collaboration between pharmaceutical companies and primary container suppliers is essential, and every step of the value chain—from drug formulation to container manufacturing—needs to be optimized to minimize and control particle levels.
In this presentation, Terumo will share the perspective of a primary container supplier, including a case study on improving the ready-to-fill syringe manufacturing process to achieve lower and more consistent particle levels in syringes for intravitreal injection. We invite you to join this session to learn how safer and more reliable intravitreal therapies can be realized through continuous improvements in container design and manufacturing.
Key Learning Objectives
- Understand the importance of particulate control in intravitreal PFS
- Learn the key factors for minimizing particulates
- Recognize effective approaches for particulate reduction
- Gain insights from Terumo’s continuous improvement case study
