Solutions

We have a solution for everything – and the corresponding experience. In our current seven areas of expertise, we are at your disposal with our comprehensive know-how.

All Solutions

Please, come in!

24/7 available for you: In our virtual showroom, we present our extensive portfolio and latest innovations. 

Software

Software

With our PAS-X Manufacturing Execution System (MES) and software solutions for Analysis, Track & Trace, Networked Factories, and Intelligent Packaging, we are the world's leading supplier and partner to the pharmaceutical and biotech industries.

Overview Software

Connext Asia

Online, Nov. 22nd - 26th, 2021
Five day virtual pharma software summit, dedicated to specific regions in Asia

Handling

Handling

We are specialists for complete handling systems for pharmaceutical and medical products. Our solutions are decisive in the field of contactless and safe transport of e.g. glass syringes.

Overview Handling

Inspection

Inspection

As the world's leading inspection expert, we develop solutions for the pharmaceutical and biotech industries. Our range of products extends from high-performance machines and semi-automatic machines to laboratory units and inspection applications for in-process control.

Overview Inspection

Machine finder

Packaging materials

Packaging materials

As long-standing specialists, we develop packaging solutions for innovative and high-quality secondary pharmaceutical packaging made of cardboard. We offer you solutions for counterfeit protection, standard folding boxes and much more.

Overview Packaging materials

Services

You need help with a specific product or have questions about one of our areas of expertise? Take advantage of our extensive range of services, we will support you quickly and easily.

All Services

Packaging materials

Packaging materials

The demands on pharmaceutical packaging are high: it should be forgery-proof and childproof, but also compact and sustainable. Find out here how we make packaging future-proof.

Overview Packaging materials Services

About us

We at Körber in the Pharmaceuticals business area are the people to contact when it comes to pharmaceutical products. As a leading system provider, we advise our customers from the development and production to the inspection and packaging of their products.

All about us

References

References

Would you like to know how we have solved different customer requirements sustainably and efficiently? 
What project partners say about us or which industry awards our innovations have received? 

CMC statistical consulting: validate processes, optimize quality

Would you like to know how to successfully validate your processes, achieve regulatory filing and further improve the quality of your products? Use our process knowledge and statistical toolbox to gain deeper insights into your processes.  

To do this, we combine biotechnological process knowledge with state-of-the-art data analysis methods. Benefit from our experience in the entire process lifecycle: process characterization, process performance qualification and continued process verification. By applying statistical best practices and our expert knowledge, you efficiently validate your processes and optimize individual process steps in a targeted manner. In this way, you improve the quality of your products, increase productivity and have clear lines of argumentation in interactions with the regulatory authorities (FDA, EMA, etc.).

Ensure reliable process characterizations, rapid technology transfers, robust quality controls, and compliant process validation campaigns.

Get in touch with our data scientists for the following topics:

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  • Experimental designs for process development and characterization studies
  • Integrated process modeling
  • Customized statistical methods for process development and characterization studies
  • Scale-down model evaluation
  • Accelerated and unbiased risk analysis
  • Data-driven risk rankings to enable linkage with development and product data 
  • Continued process verification (CPV): planning and implementation of CPV programs 
  • Statistical process control
  • Equivalence analyses for process changes
  • Optimization of bioassays in analytical development
  • Process characterization
  • Design of experiment (DoE): planning or analysis
  • Risk assessment: holistic and data-based
  • Scale-down model evaluation
  • Criticality assessment: CPP / CQA identification
  • Control strategy development: NOR, PAR, design space
  • Process performance qualification (PPQ): statistical justification for the number of PPQ runs and samples (inter- and intra-batch variability)
  • Integrated process modeling
  • Accelerated and targeted corrective and preventive action (CAPA) processes based on structured data analysis
  • Yield improvement: model concepts for yield improvement
  • GMP data mining and analysis
  • Integrated process modeling
  • Deviation management and justifications using integrated process modeling
  • Real-time batch release using integrated process modeling
  • Soft sensors: development and optimization
  • PAT technologies: development and analysis
  • Real-time data analysis during operation (univariate and multivariate)

Your benefits

Faster implementation

Rapid approval and validation of manufacturing processes according to regulatory requirements

Higher success rate

Faster reliable and mathematically sound results thanks to our statistical reporting 

Real added value

Identifying potential and increasing productivity with the right data

Any questions?

Get in contact with us. We are happy to advise you about our solutions and services.

Get in contact

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