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Engineered to address the rigorous requirements and complexity of biologics manufacture
March 19, 2020
By: Kristin Brooks
Managing Editor, Contract Pharma
Sartorius Stedim Biotech has launched BIOSTAT STR Generation 3 single-use bioreactor and BIOBRAIN automation platform designed to make biopharmaceutical development and production faster, simpler and safer. BIOSTAT STR industrial platform consists of hardware, software and consumables for single-use process development and commercial biomanufacturing. BIOSTAT STR bioreactors and Flexsafe STR bags range from 12.5L to 2000L in working volume. The system is powered by BIOBRAIN, a new automation platform designed to give biologics manufacturers the flexibility to configure the BIOSTAT STR system to meet their specific needs. According to the company, data-driven software, a suite of analytical tools and engineering design and support teams help manufacturers to produce consistent results. The flexibility and responsive nature of the BIOSTAT STR system aims to deliver quality and productivity for a stable, predictable process. Fully integrated and redundant single-use sensors provide real-time data to measure and control key critical process parameters such as pH, DO, viable biomass, glucose, lactate and foam. Non-invasive measurements save set-up time, prevent interface issues and reduce the need for off-line manual sampling. These monitoring and control systems are designed to enhance batch-to-batch consistency. BIOSTAT STR Generation 3 is ready for process intensification and includes functionalities such as feed controls, bleed controls and connectivity to Repligen’s XCell ATF cell retention devices to increase cell density and productivity. According to the company, connection to Umetrics SIMCA enables predictive, multivariate modeling and control, allowing manufacturers to predict yield and optimal harvest time points at the early stages of the perfusion process.
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