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Bioprocess Development & Engineering

Proven Track Record in Project Timeline Reduction

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. 

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

From Concept to Realization

Our Integrated Solutions Teams at Guxhagen, Germany, and Bangalore, India, develop and implement rapid and cost-effective biomanufacturing solutions from early phase development through scale-up to commercial manufacturing. Our proven process for engineering design will help our customers to optimize capital costs, operating costs and facility throughput whilst ensuring to meet critical project timelines. Our goal is to enable such customers to produce innovative and safe biopharmaceuticals to finally secure the health of people around the globe.

Also Watch Customer Interview with Synthon

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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

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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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Read More on Partnering with a Total Solution Provider

Single-Use Modules - Expedite Total Solutions

Genetic Engineering & Biotechnology News, November 1 2018, Vol. 38 No. 19

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Tested and Qualified

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

Read More on Regulatory Compliance

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.

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

Process Consulting and Engineering, Sartorius

Jan Schaefer

We provide a flexible bioprocess engineering service that puts your process at the heart of everything we do. The production platforms we deliver should meet the needs of your process, rather than having to fit your process to our equipment.

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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