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Investigation of sub-visible and visible particles is often challenging, in large part, due to the limited amount of available samples. Many of these analytical challenges arise during composition identification or in the course of the root cause investigation—making it difficult to determine the particle’s origin or formation process. This is readily apparent during the manufacturing of parenteral drug products select DP union where the need to limit the presence of any sub-visible or visible particulate matter is paramount to ensure patient safety and compliance. For parenteral DP, full visual inspection is mandatory, followed by tier inspection according to acceptable quality levels tests. The test is performed in a probabilistic fashion, with a potential risk of overlooking units containing some visible particulate matters.

In this GEN webinar, we will discuss examples of two types of visible particle identification and the root cause investigation. Additionally, we will hear about case studies that focus on a polymeric particle isolated during large-scale downstream manufacturing of a small molecule API, as well as studies that relate to the investigation of an increased, unexplained amount of sub-visible particle observed when analyzing DP in simulated clinic conditions.
A live Q&A session followed the presentations, offering a chance to pose questions to our expert panelist.

Produced with support from:

Lonza pharma & biotech
Pascal Chalus, PhD
Pascal Chalus, PhD
Senior Principal Scientist