Qualification of low drift single-use pH sensors for use in single-use bioreactor platforms

摘要

The biopharmaceutical industry is currently limited by access to low drift, gamma stable easy-to-integrate single-use pH sensors for application in single-use bioreactors (S.U.B ). Hamilton Company has developed the OneFerm VP 70 sensor, a unique single-use glass electrode, which provides an additional option for customers wishing to implement reliable single-use pH sensing capabilities in the S.U.B platform. In order to demonstrate the efficacy of these devices, a series of qualification experiments were carried out using a Thermo Fisher Scientific 50L bioprocess container (BPC) custom-fitted with Hamilton OneFerm sensors. BPCs were manufactured in a cGMP facility and allowed to age for a pre-established cell run was executed using an in-house CHO-S cell line (mAb producing clone) and standard operating conditions. Online pH was controlled with a Hamilton EasyFerm pH sensor; reactor pH was controlled using CO_2 without acid or base. Each BPC was built with six OneFerm sensors (containing two each from three different production lots), which were monitored using stand-alone transmitters. Offline samples were evaluated every 24 hours using an Oakton pH sensor.