Single-Use Manufacturing Has Never Been Easier


Robust and Easy-To-Use Production Platform

The BIOSTAT STR® and BIOSTAT® RM single-use bioreactor families are the ideal platform for your flexible manufacturing facility supporting fed-batch and continuous processes. Regardless of whether you work in suspension culture or with microcarriers, you can rely on our proven stirred tank design for fast capacity creation and safe process transfers within your company network. Our Integrated Solutions experts will help you to design and commission your manufacturing facility in line with your requirements.

 

Proven Stirred Tank Technology


Mitigate Risks Associated with Single-Use Production


The BIOSTAT STR® family provides the ideal, easy to scale platform for your flexible single-use production needs. Our holistic process safety concept based on our Flexsafe® bags, easy installation and pre-use bag testing makes single-use bioreactor operation reliable and safe. With our MFCS system you get a CFR21 compliant plug and play SCADA solution that can be enhanced with chemometrics tools for monitoring and control of your process.

 

Flexible Commercial Factory with Hybrid Manufacturing Approach


Facility Design and Construction Satisfying Global GMP Standards


DM bio’s competitiveness is strengthened by a process design allowing simultaneous production of multiple products. Moreover, their hybrid and flexible production system integrates the advantages of single-use and multi-use technologies to produce recombinant protein drugs efficiently, safely and cost effectively at various process scales.

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Less Class C Space


Stackable CO2 Incubators for Reliable Inoculum Preparation


Our CO2 incubator shakers CERTOMAT® CTplus designed to meet rigorous GMP requirements. The variable mass compensation technology enables safe and reliable operation even when two or three incubation shakers are stacked. The purpose built design guarantees even and precise temperature control. The incubation chambers are effectively sealed to minimize expensive CO2 consumption.

Proven and Cost Effective Seed Expansion


Rely on Technology Used for Decades in Commercial Seed Trains


Wave based single-use bioreactor technology is a well-established and proven, yet cost effective method to establish a fully single-use seed train. In combination with our new Flexsafe® RM bags with full traceability and control of raw materials you benefit from excellent and reproducible cell growth, regardless of the bag lot or the sensitivity of your production cell line and media combination. Scale-up beyond the 100 L scale is easily achieved with our classic stirred tank single-use bioreactors all the way to 2000 L.

 

Excellent and Reproducible Cell Growth is Cell Line and Bag Dependent


New Flexsafe® Bioprocessing Bags Demonstrate Superior Cell Growth


An independent DECHEMA working group studied a number of single-use bags with a panel of different cell lines and serum or protein free media and found that certain bags showed impaired cell growth of some cell lines. With Sartorius new polyethylene film S80 (6) and also new EVA film S71 (4), excellent and reproducible growth was achieved.

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Reliable Data Acquisition, Monitoring and Control


Turnkey SCADA Solution Specialized for Bioprocesses


The BioPAT® MFCS is designed as a “plug-and-play” tool for advanced SCADA functionalities. It is ideally suited for capturing, storing and visualizing process data of all BIOSTAT® and ambr® bioreactors and other process equipment. It is a 21 CFR Part 11 compliant feature-rich, GAMP 5 category 4 software package. Besides the core functionality of a full-fledged SCADA system, it also provides advanced chemometrics tools for data analysis and experimental design.

 

Your Fast Lane to Production


Engineering Platform for Stainless Steel and Hybrid Manufacturing Plants


The large scale stainless steel fermenter | bioreactor platform of Sartorius is based on decades of engineering experience and detailed understanding of biopharmaceutical manufacturing processes and specific customer requirements. This platform virtually eliminates the time-consuming engineering efforts that are normally required for establishing P&IDs, 3D designs and implementation of control software. Benefit from our hybrid process solutions to meet your cost of goods targets.

Integrated Solutions

 

Speed to Clinic


Ready-To-Use Bioanalytical & Biosafety


BioOutsource offer a range of services to support the testing of biologic drugs and vaccines throughout preclinical development, manufacturing and lot release. In particular, BioOutsource specialise in biosimilar testing services for monoclonal antibodies.

Cost-Effective and Flexible Facilities


Your Biomanufacturing Solutions Partner


The Sartorius Integrated Solutions team works with you to design and commission your biological production facility based on single-use or hybrid technologies. We rapidly deliver and implement flexible, regulatory compliant and cost-effective biomanufacturing solutions for clinical trial and commercial manufacturing.


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