Study of the Stability of Sandoz Rituximab Biosimilar Rixathon^®/Riximyo^® When Subjected for up to 21 Days to Ambient Storage.

ABSTRACT:

Aim

The purpose of this study was to evaluate the extended physicochemical and biological stability of Sandoz Rixathon®/Riximyo® (SDZ-RTX) after exposure to out-of-fridge (OOF) conditions.

Materials and methods

The impact of the short-term temperature excursion on stability parameters of SDZ-RTX was simulated by subsequently exposing the three batches of SDZ-RTX (100 and 500 mg) to OOF conditions, (I) 25 ± 2 °C/60 ± 5% relative humidity (RH) and (II) 30 ± 2 °C/65 ± 5% RH, for up to 21 days after more than the claimed 36-month shelf-life storage in long-term conditions (5 ± 3 °C). Analytical methods used included the cation exchange chromatography (CEX), size exclusion chromatography (SEC), and non-reducing capillary electrophoresis-sodium dodecyl sulfate (nrCE-SDS), as well

SUBMITTER: Borisek R 

PROVIDER: S-EPMC9433506 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature