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The new BIOSTAT STR Generation 3 with BIOBRAIN bioproduction platform offers process intensification with automated feed and bleed and integrated cell retention functionality.
On March 9, 2020, Sartorius announced the launch of its BIOSTAT STR Generation 3 single-use bioreactor with BIOBRAIN automation platform for biopharmaceutical process development and manufacturing.
The bioreactor simplifies biologics production, consisting of hardware, software, and consumables for single-use process development and commercial biomanufacturing. Working volumes of the bioreactor and biobags used for it range from 12.5 L to 2000L. The system is powered by BIOBRAIN, a new automation platform that gives the flexibility to quickly and easily configure the BIOSTAT STR system to meet precise manufacturer needs. Data-driven software, a comprehensive suite of analytical tools, and experienced engineering design and support teams enable consistent bioproduction, even in an environment where demands change, the company stated in its press release.
The system also includes fully integrated and redundant single-use sensors that provide real-time data to measure and control key critical process parameters, such as pH, dissolved oxygen, viable biomass, glucose, lactate, and foam. In addition, non-invasive measurements save set-up time, prevent interface issues, and reduce the need for off-line manual sampling. These monitoring and control systems enhance batch-to-batch consistency and operator confidence, according to the company.
BIOSTAT STR Generation 3 is ready for process intensification and includes functionalities, such as feed controls, bleed controls, and connectivity to Repligen’s XCell alternating tangential flow filtration (ATF) cell retention devices to increase cell density and productivity.
The system also offers connection to Umetrics SIMCA software, which enables predictive, multivariate modeling and control, allowing manufacturers to predict yield and optimal harvest time points at the early stages of the perfusion process.
Manufacturers can also achieve integration into existing process infrastructure in multiple ways, including local management via the BIOSTAT STR control tower and BIOBRAIN automation platform with connection to data histories, or full process management via distributed control systems from Emerson, Siemens, or Rockwell, the company reported in its press release. An additional feature for BIOSTAT STR Generation 3 is the optional integration of native Emerson DeltaV controls supported by a Sartorius DeltaV library, which affords full access and control from DeltaV systems.
“The biopharmaceutical industry needs solutions for the many challenges involved in bringing life-changing biologics to market. Sartorius has found ways to simplify complex processes and provide proof of safety along the way. We believe the new BIOSTAT STR platform is a significant advance. It’s our way of helping the industry to bring better medicines to patients globally,” said Mario Becker, head of Product Management for Cell Culture Technologies at Sartorius, in the press release.