Previous Blogs

Particle Testing

By Olga Laskina

November 17, 2021

Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.

Particle Analysis Testing

By John Rech

May 03, 2021

Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the FDA Recalls, Market Withdrawals, & Safety Alerts database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination1.

CZ Syringe and Vial with patient and nurse

By Lynn Yao

December 28, 2020

A parenteral drug product contaminated by particles is a potential health threat. In the bloodstream, particles can cause serious issues, such as capillary occlusion and immunogenic responses. In most cases, the observation of particles in a drug product leads to a recall.

Particle Testing

By Olga Laskina

March 01, 2019

Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.

Two scientists in the lab

By Susan Dounce, PhD

February 20, 2019

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

HSP of the lyophilized BSA powder determined by HSPIP software

By Page McAndrew

January 16, 2018

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.