Embedded Particles
in Single-Use Bags

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.

Be Aware of Future Market Trends

In 2017, the BioPhorum Operations Group* (BPOG) published the Biomanufacturing Technology Roadmap.

They identified four market trends that are likely to lead to major changes in the biopharmaceutical industry:

  1. Continued market growth
  2. Arrival of new product classes
  3. Uncertainty in product success and sales
  4. Cost pressure

BPOG concluded that a step-change in business performance must occur. They identified quality, cost, flexibility and speed as critical success factors for the future.

More about BPOG

*The BioPhorum Operations Group (BPOG) is a collection of approximately 50 companies encompassing 80% of the global commercial biopharmaceutical capacity. In 2017, they published two documents which optimize the detection of potential leachables and extractables: “Best Practices Guide for Evaluating Leachables Risk from Polymeric Single-Use Systems Used in Biopharmaceutical Manufacturing” and “Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing”

Interviews Around Single-Use

Interview About Rapid Implementation of a Single-Use Gmp Manufacturing Facility

Nienke Vriezen, Director of USP Development & Manufacturing at Synthon and Miriam Monge, Head of Segment Marketing mAbs Sartorius Stedim Biotech

Watch this exclusive interview by Miriam Monge and discover how Sartorius supported Synthon (a pharmaceutical company with focus on next-generation cancer drugs) to rapidly implement a flexible single-use facility for the manufacture of mAbs.

BWB TV: Interview About Single-Use in Commercial Manufacturing and the Status of True Continuous Manufacturing

Dan Stanton, Editor at BioProcess Insider and Miriam Monge, Head of Segment Marketing mAbs at Sartorius Stedim Biotech

Watch this exclusive interview by Dan Stanton and discover the ongoing process of reaching true continuous manufacturing in the bioprocessing industry and the regulatory issues around single-use technologies.

BPI TV: Interview About the Foundations of Single-Use

Cheryl Scott, Senior Technical Editor at BioProcess International and Jean-Marc Cappia, Head of Segment Marketing Vaccines at Sartorius Stedim Biotech

Watch this exclusive interview by Cheryl Scott and experience the changing landscape of single-use in bioprocessing and how a leading supplier to the biopharmaceutical industry is redefining its technology to meet the challenges of the market.

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