High Productivity and Process Economy in GxP Applications with Octet

Quantitation assays must show precision, accuracy, linearity, and reproducibility.

To be used for GMP applications, they must be developed with technologies that adhere to regulatory compliance. Sartorius offers comprehensive GxP packages for Octet^® platform users including installation, operational and performance qualification, validation, and support solutions to ensure compliance in the regulatory space.

This scientific poster provides a brief overview of why the Octet^® system is increasingly being used for compliance at various stages of drug discovery and development including in GMP applications and highlights how Octet^® systems can improve process productivity and economy. An example showcasing the Octet’s^® suitability for developing stability indicating methods, with one such method exhibiting excellent reproducibility and accuracy  (90%-110% dose recovery), is illustrated.