Rapidly Produce Materials for Clinical Trials


Get to the Clinic Faster With Single-Use Production Solutions

Our range of fully scalable bioreactors from cell line and process development to production ensures rapid process development and straightforward production of clinical trial materials. The BIOSTAT® RM and BIOSTAT STR® family together with our new Flexsafe® bag range provide the ideal platform for your flexible single-use production needs. With our BioPAT® MFCS system you get a 21 CFR Part 11 compliant plug and play SCADA solution for monitoring and control of your process.

 

Single-Use Manufacturing Has Never Been Easier


Robust and Easy-To-Use Production Platform


The BIOSTAT STR® single-use bioreactor family is 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 a proven stirred tank design for fast capacity creation and safe process transfers within your company network. Our holistic process safety concept based on our Flexsafe® bags, easy installation and pre-use bag testing makes single-use bioreactor operation reliable, safe and easy.

 

Rapid Production of Clinical Trials Material


Heidemann, Fenge, Cruz, Sherman, Martin, Wu (2014) BioPharm International (Volume 27, Issue 10) Oct 2014


Successful incorporation of single-use bioreactors as part of a fed-batch platform technology for the production of clinical biopharmaceuticals. By matching general reactor characteristics, the authors were able to scale-up fed-batch processes from traditional bench-scale bioreactors to large-scale single-use systems without any significant operational differences or changes in critical product quality attributes.

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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 polyethylene film 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.

Less Class C Space


Stackable CO2 Incubators for Reliable Inoculum Preparation


Our CO2 incubator shakers CERTOMAT® CTplus are 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.

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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