Blogs

Neovascular diseases of the eye are often chronic conditions treated with repeated intravitreal anti-VEGF injections. Although anti-VEGF therapies are preventing blindness, there are unique risks to intravitreal drug delivery that are exacerbated by the injection frequency. In particular, there is clinical evidence to suggest that some complications of these injections, though rare, might be tied to injection of particulate matter such as silicone oil, protein aggregates and foreign particulates.^1,2

The level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).

West presented a webinar: Navigating Particle Challenges in Sterile Drugs from Component to Patient by Fran DeGrazio, Vice-President, Scientific Affairs & Technical Services, and John Rech, Technology Manager – Particles, Analytical Lab Services, LLC.

In the pharmaceutical industry, it is well known that: The drug product picks the package. Not all package systems are compatible with a particular drug product.