For Accurate Process Fingerprinting of Cell Culture in Thermo Single-use Bioreactors
Aberystwyth, UK: Aber Instruments (Aber), a world-leading manufacturer of on-line biomass monitoring technology, is delighted to announce its new Futura neotf single-use biomass sensor is available. The new sensor designed for easy integration with Thermo Scientific (Thermo) single-use bioreactors allows accurate process fingerprinting for on-line monitoring and control of cell culture, making it ideal for supporting seamless scale-up with biologics and vaccine manufacturing.
Based on Aber’s long-established, capacitance measurement technology, the Futura neotf single-use sensor can measure biomass on-line in a Thermo single-use bioreactor every 4 seconds. Unlike off-line biomass measurement approaches which are time‐consuming and generate few data points, capacitance is sample-less and allows walk-away analysis, and collection of large amounts of real-time data without removing samples from the bioreactor. Process development runs can rapidly provide all the data to generate accurate fingerprints of a cell culture process to support Quality by Design (QbD).
Utilizing process fingerprints from Futura neotf, scientists can for example, maintain critical process parameters (CPPs) and critical quality attributes (CQAs) of their biologics and vaccines from batch to batch and can rapidly identify and prevent costly out of specification batches occurring. They can also use data from Futura neotf for advanced control such as determining optimum cell harvest or virus infection times, potentially improving product yield and quality, as well as reducing cost of goods.
Consisting of a head amplifier and a single-use sensor, Futura neotf can easily be integrated via a proprietary port into Thermo single-use bioreactor ranges including the HyPerforma™. Developed with scalability in mind, the technology is compatible across sizes in bioreactors from 50 L to 2000 L, making it scalable through process development, clinical trials, and Current Good Manufacturing Practice (cGMP) cell culture production.
Futura neotf has been successfully tested internally by Thermo and externally by a major biopharmaceutical company to measure viable cell concentration (VCC) of Chinese hamster ovary (CHO) cells as part of its bioprocessing 4.0 workflow. The studies demonstrate that the single-use sensor was successful as a Process Analytical Technology (PAT) tool for measuring cell density in real-time with batch, fed-batch and perfusion applications.
John Poppleton, Director of Marketing and Sales at Aber Instruments explains: “Scientists tell us their off-line methods of measuring biomass not only risk contaminating the bioreactor but are time consuming and subjective. This means they only generate data points every 12-24 hours and measurements can vary by as much as 15 %. That’s why implementing on-line capacitance sensors and especially single-use ones is a key need for many process development scientists.”
Poppleton adds: “To meet this growing demand, we are pleased to be adding Futura neotf to our trusted biomass sensor range. The benefits for scientists working with Thermo single-use bioreactors are that they can now access our unrivalled technology to generate accurate process fingerprints to support QbD programmes and potentially drive down their biologics and vaccine manufacturing timelines.”
Due to the high level of interest anticipated following product release, Aber will prioritize supply of Futura neotf single-use on-line biomass sensors based on experience with the technology and its application. Wider access will come later in 2021 and scientists wanting to find out more about the new Futura neotf single-use on-line biomass sensor, should click this link: www.aberinstruments.com
Press release from Aber