Bioprocess Development Engineering

Proven Track Record in Project Timeline Reduction: Decouple Process Design From Facility Design

We provide a unique implementation methodology for your bioprocess using single-use technologies wherever possible and hybrid solutions as appropriate for your type & scale of process. Our teams develop the layout, workflow and design of your process based upon your single-use equipment selection. In parallel to your facility build, we design, test and qualify all single-use technologies used within your process, thus significantly improving your speed-to-market.

How do we add value to our customers?

  •     Early phase consultancy and process development services
  •     Facility and conceptual layout capabilities
  •     Facility cost estimation capabilities
  •     Feasibility studies
  •     Implementation support
  •     Service Contracts ensuring optimum process performance and reliability

Discover our Project Phases:

Our Integrated Solutions Team develops and implements rapid and cost-effective biomanufacturing solutions from early phase development through scale-up to commercial manufacturing.

Step 1: Process Optimization

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Step 2: Process Modelling

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Step 3: Conceptual Design

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Step 4: Basic Engineering

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Step 5: Detailed Engineering

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Step 6: Project Execution (SAT)

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Take the complexity out of intensified processing

Develop the essential control strategies with the ambr® 250 high throughput perfusion with integrated Umetrics® Suite of Data Analytics Solutions.

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Over 200 Successful Fully Single-Use Project Implementations

We design a bioprocess with maximum flexibility in mind to facilitate changing requirements and tailor our offering around your business scenario.

Discover our Case Studies

Rituximab candidate produced via first fully single-use process

"Single Use technologies are the perfect choice for biosimilar producers, since it allows us to lower the upfront investment." - Dr. Jaros, Mabion

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Consulting Expertise to Drive Efficient Process Development

Our Process Development team will work with you from pre-clinical through phases I & II to optimize your process before design and technology choices are locked-down. We use unique modeling and multi scenario analysis tools to streamline process design and technology options, ensuring you achieve the highest productivity and lowest cost of goods.

Design Considerations

Working with single-use closed systems; our team can downsize higher classification clean room areas. For example, large-volume support solutions can be stationed in a CNC (Controlled Non-Classified) environment and fed through the wall using a transfer hatch into the higher classification areas. With a Single Use based design, ISO7 and ISO8 clean room surfaces can be reduced by an average of 20%. Clean room volumes can be decreased by over 25% as a result of being able to lower the ceiling heights that are typically required for stainless steel bioreactors, and HVAC systems can be downsized by an average of 33%.

Please view the video for a dynamic view on the impact of single-use on facility design.

Tested and Qualified

Single-use technology testing directly after pre-concept phase.

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Integrate into your Automation Infrastructure

Critical Success Factors for Facility and Process Automation

Mitigate the risk of producing faulty batches through state-of the-art process control. Sartorius provides flexible automation platforms to match your specific requirements, such as Sartorius Proprietary Solutions and Industrial Solutions.

There is no single automation standard in the pharmaceutical industry. Sartorius strictly follows the GAMP5 principles of the V-model in our process automation implementation. Clearly defined user requirements specifications enable our automation engineers to develop functional specifications for hardware and software design qualification.

Sartorius Stedim Biotech is now collaborating with Siemens in the area of automation. Have a look at the new Bioprocess automation platform Sartorius Stedim Biotech will feature in the future with Siemens as preferred supplier. The modular open architecture platform is specifically designed for single-use unit operations. Key functionalities include a flexible integration into existing and new SCADA and DCS systems such as Emersons DeltaV and Rockwell as well as Siemens PCS 7 and Batch. Integration is possible at “Recipe Level”, “PLC Level” and “Remote I/O Level”.

Watch the video below to learn more!

Sartorius Voices

Head of Operations BPS Systems, Sartorius Stedim Biotech

Dr. Thorsten Peuker

Integrated Solutions is designing and implementing process solutions for the biopharmaceutical industry under consideration of time-to-market, quality and cost targets. Process Automation is a key element to reach these targets. The collaboration between Sartorius and Siemens supports our customers to manage the challenges of the future.

Head of Applied BioProcessing, Sartorius Stedim Biotech

Michael Koch

When somebody next to you gets ill and the quality of life of this person gets better with help of biotech drugs enabled through our technologies, I know I’m part of it.

Siemens and Sartorius Stedim Biotech are now collaborating.

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Read more on end-to-end bioprocessing with Integrated Automation:

Solutions for End to End Bioprocessing with Integrated Automation

PDF | 1.7 MB

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Service, Support and Resources

The right contract for your service, maintenance and repair needs

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Single-use system training and application support

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Benefit from exclusive case studies, pioneering eBooks and more

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