The supply chain for single-use commercial manufacturing can be vulnerable and any change may affect the availability and quality of your biologics.
In order to control the entire single-use fluid path, we have established a global supply network and expanded our own manufacturing footprint worldwide.
We have achieved the highest level of quality and the most stringent change control in the industry for our resins, films, and components.
Our unique partnership and scientific exchange with film extruder and resin suppliers builds the foundation to obtain our assurance of quality supply.
Based on Quality by Design Principles our material experts defined critical quality attributes for our single-use solutions and transformed them into critical process parameters. These have been tested via a Design of Experiment to guarantee lot-to-lot consistent quality.
Our dynamic manufacturing network expansion best serves our customers' business continuity. This keeps us close to our customers and enables us to operate in case of any unforeseen events.
Our network includes five bag production facilities on four continents with an overall ISO-7 cleanroom capacity of 75.000 square feet - the largest in the market - and multiple locations for filtration, purification and fermentation technologies. We are currently expanding our bag manufacturing capacities to 105.000 square feet. Over the last two years we invested more than 350 Mio. EUR into infrastructure projects.
We deliver the highest level of quality in the single-use industry by the means of end-to-end control of our manufacturing process, from resin to finished product.
Our frequent quality control guarantees that our finished products are released when all critical test-release-criteria are passed.
While industry practices only perform quarterly or yearly testing, we control the level of endotoxins, bioburden, sub-visible particles and visible particles of our finished products via a weekly testing program. This avoids the risk of using an out-of-specification-bag.
Additionally, bags are leak tested and visually inspected for defects and particles during the manufacturing process.
Finished products can be integrity tested using our helium integrity test with 2 μm detection limit correlated to microbial ingress and liquid leaks.
We have established supplier contracts and quality agreements with our key suppliers to obtain a robust change control for our entire fluid path.
Combining safety stocks, last-time-buy options and early notification by our suppliers, we can guarantee robust change control. This means four years of unchanged raw materials for the films and two years for filters, tubing, sensors, fittings and connectors.
Building on our customers' requirements and our application specialists experience we developed fit-to-purpose standard solutions for end-to-end single-use processing.
By using off-the-shelf standard components we optimize customer lead times. When choosing our fit-to-purpose standard solutions, customers reduce the proliferation of stock keeping units (SKUs) as well as their inventory levels and costs.
Our intuitive customer configurator tool enables you to instantly select the appropriate single-use solution that meets your applications requirements.
Secure your product stability and integrity during long term storage and shipping
Intelligent mixing for your cGMP biomanufacturing
Bags fitting your applications for preserving bulk drug substances
Fully scalable single-use bioreactor family
Enhanced Assurance of Quality Supply
The growing adoption of Single-use technologies in all process steps of cGMP clinical and commercial production requires enhanced assurance of quality supply. Our complete control over the manufacturing steps from resins to the final bag assembly guarantees:
The growing adoption of single-use (SU) in all process steps of cGMP clinical and commercial production requires enhanced assurance of supply and robust product performance.
Growing adoption of single-use bags in commercial production of biopharmaceutical drugs raises new challenges for bag suppliers and drives the need for consistent product quality, improved assurance of supply, robust change management, and business continuity planning. Sartorius Stedim Biotech has developped a unique partnership with SüdPack, ensuring the complete control over the entire supply chain, from the resin, to the film and the final bag assembly.
The expansion of Single-Use technologies into commercial production has naturally raised new challenges for both end users and suppliers, thus driving the need for a critical look at risks associated with their use. End-users have to rely on their Single-Use suppliers as being part of their drug process. Sartorius Stedim Biotech has built the foundations of reliable Single-Use supplies thanks to the enhanced Assurance of Supply level described in this article.