Quality Control – Reliable, USP <788> Compliant Lot Release Testing

Subvisible particulates matter. Particulates in biopharmaceutical injections and parenteral infusions have been shown to provoke an undesired immune response in patients. To avoid major immunogenicity issues, the FDA has established biopharmaceutical lot release guidelines and limits for subvisible particles based on USP <788> standards.

The USP <788> describes two methods for particle detection: light obscuration (Method 1) and membrane microscopy (Method 2). Until recently, light obscuration was the preferred method over traditional membrane microscopy because it could be automated and was less error-prone. Now with Aura PTx, however, there is a fully automated membrane microscopy option available.

Aura PTx system is based on method of membrane microscopy but overcomes all the challenges with traditional membrane microscopy. Since membrane microscopy is the preferred method for complex, high viscosity, and low volume samples Aura PTx is the ideal system for final product testing to confirm product quality in many of the biopharmaceutical products currently in development

Automated USP <788> Compliant Analysis with Aura PTx

Aura PTx reinvents membrane microscopy, using modern robotics, image processing, and novel optics, to automate the analysis. A counting protocol based on the FDA’s USP <788> Method 2 guidelines includes five sequential steps which include two membrane washing steps. This method doesn’t substantially increase analysis time and can be completed with manually pipetting or automated using a robotic liquid handler.

Aura PTx’s simple workflow and automation lead to unparalleled data precision. A study evaluating inter-instrument and inter-user reproducibility where four instruments and three users each processed bead standards found that all results were within 10% of each other. Thus, particle analysis in final lot release product will be the same, regardless of the specific instrument or user running the analysis.