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.

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

Software solutions

Software solutions

With our Werum PAS-X MES - on premise or cloud-based - and our 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 solutions

Handling systems

Handling systems

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 systems

Inspection machines

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 machines

Packaging machines

We are a leading supplier of packaging machines for liquid and solid pharmaceutical and medical products. With our blister, sachet and stick packaging machines we offer solutions for primary packaging. Our side and topload cartoners set standards worldwide for secondary packaging.

Overview Packaging machines

K.Pak Topload Case Packer

Introducing our latest solution from Körber; the K.Pak Topload Case Packer! Created specifically for the pharmaceutical industry, the K.Pak solution provides operator-friendly machines to complete any production line. Our solution focuses on innovative technology, high-quality design and expert handling and packaging of your product. It’s time to start connecting the dots with Körber!

Packaging solutions

Packaging solutions

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 solutions

Consulting

Consulting

Our experts will advise you during the analysis of your requirements, show you optimisation potential and support you during the implementation of projects in all areas of the pharmaceutical, biotech and medical device industry.

Overview Consulting

PAS-X CMC Innovation Consulting: 
Validate processes and optimize quality with your digital twin factory

Would you like to know how to successfully optimize, validate, achieve regulatory filing, and further improve the quality of your products? Use our unique combination of process knowledge and data science expertise to reduce time-to-market and consistently improve process performance and robustness.

At Körber, we blend biotechnological process expertise with cutting-edge data analysis techniques. With over 10 years of hands-on experience, we deploy data science tools across the entire process lifecycle – from characterization and performance qualification to continued process verification and real-time control. Our track record includes successfully supporting the commercialization of 20+ pharmaceutical products. Applying statistical best practices, advanced modelling approaches, and end-to-end modelling, coupled with our expert knowledge, we help you optimize, validate, and control your processes efficiently. This approach enhances product quality, boosts productivity, and provides a robust foundation for discussions with regulatory authorities (FDA, EMA, etc.).

Together, we ensure reliable process characterizations, rapid technology transfers, compliant process validation campaigns and robust process control.

lWe accelerate your process commercialization and increase your productivity! Benefit from our 10 years of experiences at the interface between data analytics and process knowledger

Dr. Thomas Zahel, Head of CMC Innovation Consulting, Körber Business Area Pharma

Process validation consists of three stages that are interlinked to each other.

The first one, Process Characterization, is the most essential step to establish a Control Strategy in accordance with FDA, EMA and ICH guidelines, ensuring consistent product quality. To achieve this activity, the relationship between process inputs (process parameters, material attributes) and the process output (critical quality attributes, product amount) needs to be understood and controlled. This relationship can be learned from data and prior knowledge.

Our unique workflow guides you through this critical phase, comprising:

  1. Risk assessment
  2. Scale down model establishment and comparison
  3. Experimental design (for statistical and dynamic models)
  4. Experimental analysis and criticality assessment (linear regression models, linear mixed models including random effects, dynamic models for up- and downstream)
  5. Setting a holistic control strategy using the end-to-end process modelling framework

With over a decade of experience and involvement in more than 20 product commercialization, we've fostered productive exchanges with regulatory authorities and have gained expertise across diverse product areas like monoclonal antibodies, recombinant protein, pDNA, and more.

We have published over 10 peer reviewed papers with large pharmaceutical companies like Boehringer Ingelheim and Takeda that demonstrate the effectiveness of our approach. In a recent peer-reviewed scientific publication, we demonstrated that our method results in a reduction of over 50% in the number of experiments required by leveraging self-learning digital shadows. This method was also demonstrated at many conferences like the 2023 ISPE Biotechnology conference

We support you with:

  • Faster time-to-market by reducing number of experiments by >50%
  • Regulatory accepted workflows and risk assessments according to ICH Q9 / ICH Q12
  • Holistic control strategies leading along ICH Q8 to widest possible PARs and design spaces
  • Data based criticality assessment of process parameters
  • Timely delivery of results

In the second step, we consult you in determining the number of runs needed for a (Process Performance Qualification (PPQ) campaign.

We support you with:

  • Drafting a PPQ protocol
  • Statistical determination of number of PPQ runs
  • PPQ execution

Continued process verification (CPV) is the third step of the process validation life cycle and ensures that the process is in state of control during commercial manufacturing. Within a CPV plan, it is specified which CQAs (Critical Quality Attributes) and which CPPs (Critical Process Parameters) are monitored on a regular basis. The plan also defines which trending rules and control limits will be used, how often sampling must be performed, and how to invest and communicate when trend violations occur.

In general, the establishment of the CPV plan can be divided into two phases:

  1. Initial CPV Plan
    1. Number of available data is too small for statistical application
    2. Process knowledge in manufacturing is too low for reduction sampling frequency
    3. List of monitoring CPPs and even CQAs are at maximum
  2. Full CPV Plan
    1. Data is sufficient for statistical application
    2. Process knowledge increases
    3. Sampling frequency can be reduced and number of CQA and CPPs can be decreased

We have strong expert knowledge in this area and can facilitate the creation of an efficient and goal oriented CPV plan creation or update of your process.

Key to successful CPV is the right CPV plan, followed by lean and transparent execution. End-to-end process models empower to differentiate between normal and special cause variation

We support you with:

  • Definition of methods for trending
  • Selection of CPPs and CQAs for monitoring
  • Calculation of control limits
  • Support to iteratively reduce the sampling plan

Most of the process steps in biopharmaceutical manufacturing have a time dynamic behavior. Instead of looking at the end values, e.g., end of fermentation or end pool value of chromatography, we can make use of measurements on the time evolution of critical quality attributes, metabolites, and product amount.

First principles, like mass balances or diffusion phenomena, can be combined with data-driven models that describe reaction mechanisms or binding isotherms. 

This methodology brings benefits along the entire process life cycle:

  • Process Development for faster optimization
  • Process Characterization for reduction of the number of experiments
  • CPV for reduction of false alarms

With this, we can generate generalizable process knowledge across scales and products and establish a process knowledge platform that enables fast time to market and reduction of cost of goods in manufacturing via real-time control.

Hybrid and mechanistic models for (A) fermentation and (B) chromatography processes.

We support you with:

  • Establishment of time dynamic models for USP and DSP
  • Experimental design to reduce number of experiments
  • Offline application to optimize the process performance and set up ICH Q8 relevant control strategies
  • Real time application to control the process in closed loop

Biosimilars have emerged as affordable alternatives to approved biologic drugs, meeting the industry's growing demand for cost-effective treatment options. These medicines provide effective and safe therapies while reducing the financial burden on patients and healthcare systems. 

The critical question in this area is: How can we achieve and prove that a biosimilar is similar enough? We have worked for years to develop new statistical methods that enable biosimilar manufacturers to develop a manufacturing process that results in biosimilars that pass the bioequivalence test. For that we have developed a clear workflow that follows a systematic way of experimental design and analysis to establish a control strategy that ensures chances of passing the final analytical biosimilarity assessment and getting drug approval. 

Adopting a regulatory compliant analytical bootstrapping test that controls the Type I error enables companies to establish analytical similarity, leading to faster market entry with a 10 percent higher acceptance rate.

By adopting our bootstrapping test, you can confidently establish the analytical similarity of your biosimilar product and hence safe costly clinical trials.

We support you with:

  • A systematic approach to ensure analytical biosimilarity 
  • Circumventing flawed x-SD approaches and other simple range tests that are questioned in recent regulatory expectations
  • Using the correct, scientifically sound, and regulatory accepted analytical biosimilarity test
  • Maximizing the chances of drug approval

Digital shadows and digital twins come into play during process development and process validation, but can reach their full potential during reoccurring manufacturing. This is where we use our unique and innovative end-to-end process models to predict the impact of deviations and help to manage and justify them faster. This is a digital shadow application as it does not connect or control the process in real time. However, it has huge benefits as it saves costly investigations and CAPAs. 

End-to-end process models can act as digital shadows during manufacturing execution in predicting the impact of a deviation onto product quality and amount.

We support you with:

  • Establishment of end-to-end digital shadows from process development and manufacturing data
  • Validation and verification of end-to-end process models along regulatory guidelines and V&V40 standards

Numerous FDA and EMA initiatives advocate automatic real-time control, transitioning away from quality-by-testing to Quality by Design (QbD).

Our unique and innovative end-to-end process models can be used as prescriptive analytics that work like Google Maps. If you deviate from the optimal path in manufacturing (e.g., deviation in process parameters), it acts as recommender system to guide you back on track. 

It predicts optimal changes to the rest of the manufacturing process across multiple process steps to reduce the likelihood of process failures due to quality issues and increases the total yield of the process. This results in a substantial reduction in the cost of goods by more than 20% and provides a recurring revenue stream for our customers.

The PAS-X Savvy digital twin connects with the PAS-X MES system to provide a unique capability to control, monitor and document the process changes introduced.

A recommender system using end-to-end process models enables to increase overall yield and product quality by >10%. Recommendations are displayed and can be automatically or manually accepted after documentation. Automatic interfaces to the shopfloor (MES, SCADA) allow seamless data transfer from the process and writing of new setpoints into the MES system for subsequent execution.

We support you with:

  • Establishment of end-to-end digital twins from process development and manufacturing data
  • Validation and verification of end-to-end process models along regulatory guidelines and V&V40 standards
  • Connection of end-to-end process digital twins to middleware, SCADA, QMS and MES systems

Factsheet: Integrated process modelling with Werum PAS-X Savvy

With its breakthrough innovation Process Models (PMs), Werum PAS-X Savvy enables a holistic control strategy, deviation management and batch release in real time

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Your benefits

Faster Time-to-Market

  • Rapid approval and validation of manufacturing processes according to regulatory requirements
  • Reducing number of experiments by more than 50% to obtain sufficient process knowledge

Higher success rate

  • Faster reliable and mathematically sound results thanks to our statistical reporting
  • Increased success rate of meeting specifications in manufacturing using holistic control strategies and digital twins

Real added value

  • Identifying potential and increasing productivity with the right data
  • Lowering costs of goods by more than 20% and establishing a reoccurring revenue stream for our clients

Successful process characterization in biotech

A how-to-guide in 7 steps for faster time-to-market 

Read the blog article

Analytical biosimilarity

How to test regulatory compliantly for analytical biosimilarity and reduce business risk

Read the blog article

End-to-end digital twin

How a self-learning digital twin enables the reduction of experiments in PCS by more than 50%

Read the blog article

Werum PAS-X Savvy

Werum PAS-X Savvy from Körber combines the management, visualization, and analysis of data from a variety of sources using automated reports of the findings in an intuitive software environment. This way, you can accelerate pharmaceutical and biopharmaceutical product development, ensure product commercialization, and optimize productivity.

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Any questions?

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

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