header-image_A-Z_700x150Single-Use Manufacturing Series

Innovations, Data, and Thought-Leadership

This series, will give you valuable insights into the efficiency of single-use for the biopharma industry - especially its manufacturing processes. You will discover the current marked business drivers and experience several related possibilities to overcome these challenges.

By combining knowledge and generating extensive expertise, Sartorius Stedim Biotech is developing solutions which take biopharmas a step closer to their ideal world in bioprocessing.

Watch out for Sartorius Stedim Biotech’s complete Single-Use Manufacturing Series throughout 2019 to access the latest information about the company’s’ technological capabilities, upcoming products and its innovations for process optimization.


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Going Beyond the Simple
Customer–Supplier Relationship: Ensuring a High-Quality Supply Chain Through Transparent Partnerships

Operating a successful global supply chain to deliver single-use systems (SUS) for utilization in the biopharmaceutical industry is complex. In his insightful article, Claudio Catallo, Head of Global Supply Chain Management FMT at Sartorius Stedim Biotech, details the company’s intelligent approach to supply chain management and the models it uses. He also explains how expert teams and integration of digitalization across many sales, manufacturing, and distribution sites maintain the operational excellence required to support supply and demand in an ever-changing global biopharmaceutical market.
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Product Robustness,
Integrity Testing Science and Technologies for Enhanced
Process Integrity and Patient Safety

With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies. Carole Langlois and Marc Hogreve first review the emerging industry associations' initiatives and introduce an integrated quality by design, material science and process control approach as the prerequisite to SU CCI. Then they will describe how applying good science help determine the maximum allowable leakage limit (MALL). They conclude by sharing the development of highly sensitive deterministic integrity testing technologies such as gas tracer detection and pressure decay able to detect the MALL determined during the scientific study.
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Integrity Redefined: Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety

With the increasing adoption of single-use systems (SUS) in critical stages of biopharmaceutical manufacturing, any lack of system integrity can significantly affect drug product quality and patient safety, as well as incur additional costs due to product loss and disrupted production cycle. This article from Sartorius Stedim Biotech, describes how determining the correlation between liquid leakage and microbial ingress can be used to define MALLs (Maximum Allowable Leakage Limits) of SUS for different process steps. The article also details the development of methods and specifications for implementing reliable physical tests to control the integrity of SUS both at a supplier’s site and point of use.
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The Proper Use of Extractables Data: Aspects Beyond Extractables Measurement

The implementation and use of single-use system (SUS) in biopharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond “simple” extractables measurement. In this presentation, we will show how we employed our experiences to come to a deep understanding of extractables, and finally to methods to predict extractables and leachables. We will show that only an adequate physical and chemical understanding allows a correct scaling and combination of extractables data for the numerous devices and assemblies provided to the market. And we will show how a mechanistic modelling, which combines sources and sinks of leachables appropriately can be used in risk assessments to quantitatively predict leachables along a process chain.
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Visible Particulate Matter in Single-Use Bags: From Measurement to Prevention

To ensure product quality and patient safety of biopharmaceuticals manufactured in single-use (SU) systems, interactions between drug substances/products and extractables/leachables and particulate matter must be controlled. This article by Sartorius Stedim Biotech,details the results of extraction and particle classification studies where particles measured from interior surfaces of SU bags showed that all bags tested contained detectable levels of particles within the visible size range. The study concludes that tightening SU manufacturing controls should reduce the levels of particles found in future SU systems.
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Multi-Product Facility Realized by Modular Automation Platform

Multi-product facilities need modular package units to realize fast change-over without reducing product quality and process performance. Smart modular package units such as the FlexAct® platform can run pre-qualified and pre-tested recipes, users can rapidly integrate Sartorius Stedim Biotech’s and other manufacturers’ single-use technology in bioprocess operations, achieving faster installations with reduced downtime. The platform can be configured for maximum flexibility to control up to six different unit operations in a single process skid for buffer and media preparation, cell clarification, crossflow filtration, virus inactivation and retention at processing volumes ranging from 15 L to 2,000 L.
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Smart Modular Package Units for Single-Use Processing: Addressing Cost, Speed, and Flexibility Challenges in Biologics Manufacturing

How to reduce costs, while still increasing speed, and flexibility in biologics manufacturing currently represent major issues for the biopharma industry. In this article, Burkhard Joksch, Product Manager Bioprocess Automation and Stuart Tindal, Product Manager FlexAct® Platform at Sartorius Stedim Biotech GmbH, detail the evolution of automation for single-use technology towards modular packaging units. hey also including case studies of how these units can be used in real life cGMP processes, as well as explain the manufacturing and industry benefits smart modular packaging units can deliver for biomanufacturing both now, and in the future.
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Videocast: Potentials of Single-Use in Bioprocessing

The video provides a bite sized version of the podcast in which Stefan Schlack and Jean-Marc Cappia discuss their thoughts on the key drivers behind the challenges and opportunities currently facing the biopharma industry. Watch it now and If you enjoyed it but want to hear additional technical information and visionary predictions from both experts on these interesting topics, continue with the podcast.


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The Changing Landscape of Single Use in Bioprocessing: An Interview with Stefan Schlack and Jean-Marc Cappia

Single use in bioprocessing has changed significantly in recent years. To find out how a leading supplier to the biopharmaceutical industry is redefining its technology to align with new market challenges, science writer, Sue Pearson, had the opportunity to interview Stefan Schlack, Head of Bioprocess Marketing, and Jean-Marc Cappia, Head of Segment Marketing Vaccines, both at Sartorius Stedim Biotech (SSB) in Goettingen, Germany.
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Podcast: The Changing Landscape of Single-Use in Bioprocessing

Sue Pearson, Science Writer in the Biopharma Industry, interviewed Stefan Schlack, Head of Bioprocess Marketing, and Jean-Marc Cappia, Head of Segment Marketing Vaccines former Head of Fluid Management Technologies at Sartorius Stedim Biotech about the changing landscape of single-use in bioprocessing. They discuss business drivers, currently developed facts and figures as well as upcoming solutions and visionary ideas.

 


 

Redefined from A – Z. Experience the change:

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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.

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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.

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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.

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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.

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