Integrity Redefined: How to Achieve Enhanced Process Integrity and Patient Safety

Integrity Redefined: How to Achieve Enhanced Process Integrity and Patient Safety

The Foundations for Single-Use Manufacturing.
Redefined from A–Z.

The Foundations for Single-Use Manufacturing. Redefined from A–Z.

In the past, biopharma companies were struggling with various risk factors which kept them from implementing single-use solutions.

With our solid single-use foundation for biomanufacturing processes we are solving all of these challenges simultaneously. Our fully integrated single-use platform connects an exclusive approach in biocompatibility, state-of-the-art integrity control and testing as well as a unique automation platform and supply network.

This strategy provides flexibility and acceleration which leads to a cost-effective process that ensures the quality of your biologics and enhances patient safety.

Automation Redefined.

Visionary platform technologies lead to high flexibility and prevent human errors.

Benefit from our state-of-the-art automation technologies and configurable standardized solutions to experience the next step in robust production for your biologics.

Biocompatibility Redefined.

Control of our materials and processes leads to consistent quality and safety of your biologics.

Benefit from the excellent and reproducible extractables and particles profiles of our single-use solutions.

Integrity Redefined.

Consistent robustness and Integrity testing lead to enhanced process integrity and patient safety.

Benefit from our expertise in designing robust solutions, integrity testing science and technologies to de-risk your process from liquid leaks and microbial ingress.

Supply Network Redefined.

A global manufacturing footprint along with end-to-end process control leads to strong assurance of quality supply.

Benefit from high quality, robust change control and long-term business continuity through our unique supply network.

Single-Use in Commercial Manufacturing And The Status of True Continuous Manufacturing

Miriam Monge, Head of Segment Marketing – mAbs | Rec Proteins | Intensified Bioprocessing at Sartorius Stedim Biotech inteviewed by Dan Stanton, Editor at BioProcess Insider about the ongoing process of reaching true continuous manufacturing in the bioprocessing industry and the regulatory issues around single-use technologies.

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