Production at the cutting edge of biotechnology and pharmaceuticals

With the spread of modern molecular and cell technologies, the biotechnology and pharmaceutical industries are undergoing a transformation that is enabling new, advanced therapeutic approaches. New cell therapies, especially those based on stem cells, require flexible production processes in order to quickly deliver vital medicines.

Automation and networking for optimal production processes

Equip yourself with innovative systems and processes for the challenges ahead in the biotechnology and pharmaceutical industries. Automate your laboratory processes, increase throughput and quality, and reduce your costs. By networking systems, we help you to utilize process data and optimize production processes. Learn more about the advantages of automation – click here.

Customized solutions for the manufacture of ATMPs

Rely on fully automated solutions for advanced therapy medicinal products (ATMPs). Benefit from our individual support in product development and serial production to achieve the highest standards in quality and efficiency. Given the growing demand for mRNA vaccines, gene therapies, and personalized cancer therapy, scalable production solutions are essential.

Imaging techniques for quality assurance in drug development

Benefit from advanced imaging techniques such as optical coherence tomography (OCT), which provides high-resolution cross-sectional images and is crucial for biomedical research. OCT enables you to perform non-invasive analyses of dynamic processes, such as wound healing processes and cell cultures. Non-invasive measurement preserves sample integrity and makes it easy to repeat measurements. This allows you to ensure the quality and effectiveness of your therapeutics more efficiently while reducing development costs.

Reliable data analysis with artificial intelligence

Use artificial intelligence (AI) in your laboratory to dramatically optimize data analysis and decision-making. AI systems process large amounts of data, recognize patterns, and make accurate predictions that can be crucial for your drug development and diagnostics. Through the use of deep learning, we support you in efficiently analyzing medical images and estimating drug activities. Use AI-controlled robots that take over repetitive tasks and significantly increase the efficiency and accuracy of your laboratory work.

Bless you!
Our offer for the biotechnology and pharmaceutical industry

To help patients recover faster and receive high-quality medicines, we support companies in automating their production processes, ensuring the highest quality, and bringing new active ingredients to market faster.

 

Laboratory automation

The automation of bioproduction is revolutionizing the efficiency and quality of biological products, significantly reducing costs and relieving specialist staff of repetitive tasks.

We use robot-assisted systems and intelligent software to automate routine laboratory work. This enables us to significantly increase the reproducibility and throughput of your processes.

 

Quality control for cell production

In the manufacture of cell products, automated quality control enables continuous monitoring of production parameters. Using sensor technology and real-time data analysis, we ensure product integrity and detect deviations immediately. Our quality management strategies guarantee reproducibility and compliance with regulatory standards.

 

Tissue Engineering

We develop cell replacement using tissue cells produced in vitro. Our roll-to-roll facility produces micro- and nanostructured surfaces that promote the growth of stem cells into specific tissue cells to treat diseases and support natural wound healing.

 

Technology, quality and data management

We investigate the use of new and proven technologies for the manufacture of ATMPs on your behalf and work with you to develop customized system solutions for your production operations.

Successfully implemented for companies

Strategic R&D roadmap – future-oriented innovation for skin care

A skin care company based in Germany asked itself which research and development activities would be most effective in strengthening its innovative capabilities. We developed a strategic R&D roadmap that takes into account both the company's strengths and current market challenges and industry trends.

The client received a strategic project portfolio that lists and prioritizes possible initiatives. With the roadmap in place, the client can implement the strategic goals independently. Documented project results and working documents ensure the traceability of the results.

Client 

Skin care company from Germany

Assignment

R&D roadmap as a recommendation for action to strengthen innovative strength and competitiveness

Results

  • Strategic R&D project portfolio
  • Roadmap for organizational implementation
  • Documentation of all project results and working documents

Methodology

  1. Definition of the goal for the R&D technology strategy
  2. Market and core competence analysis and identification of potential areas of innovation
  3. Prioritization of areas of innovation and development of a project portfolio
  4. Development of organizational changes
  5. Derivation of a communication model
  6. Formulation of recommendations for action and derivation of concrete measures


Additional services

  • Technology scouting 
    Evaluation of existing machines and equipment on the market for setting up cell biology test laboratories and tissue engineering facilities.
  • Sustainability assessment 
    Conducting life cycle analyses in the early stages of product development.

Audit for laboratory automation: Foundation for future optimization

We systematically analyzed the current production processes for a pharmaceutical company based in the US—as a first step toward automating manual laboratory processes. Another focus was on building knowledge about laboratory automation technologies within the company so that the automated processes could be understood and successfully implemented.

A technical and economic analysis was conducted to calculate the potential for increasing production efficiency and reducing costs. A detailed 2D design of the automated production facility and an overview of the required components provided the pharmaceutical company with the basis for plant construction. A structured guide in the form of a roadmap enabled the company to implement the new processes step by step and carry out the changeover in a targeted manner.

Client 

Pharmaceutical company from the USA

Assignment 

Conducting an audit as a basis for converting the company's laboratory processes from manual to automated

Results

  • Detailed 2D design of the automated production plant
  • Parts list and specification sheets
  • Technical and economic analysis data
  • Roadmap for implementation

Methodology

  1. SOP scan: Analysis and evaluation of standard operating procedures with regard to their automation capability
  2. Current status analysis: Technical and economic analysis of the current production status and benchmarking with the state of the art
  3. Potential and gap analysis: Identification and analysis of automation potential and development gaps
  4. Strategy roadmap: Creation of a detailed implementation strategy for process automation

Additional services

  • Digitization audit 
    Have your processes checked for efficiency and gaps in digitization!
  • Good Manufacturing Practice Audit 
    Together, we evaluate requirements and formulate the necessary steps for GMP certification.

Process modeling and simulation: Optimizing the manufacturing process for cell therapy products

We modeled a process for manufacturing a cell therapy product for a German pharmaceutical company and simulated various scenarios. The aim was to generate usable data and provide a sound basis for decision-making.

The customer was given access to the model architecture and all simulation data. Additional reports documented our research team's interpretations and visualized the results of the simulation.

Client

German pharmaceutical company

Assignment

Modeling of the production process and simulation of various process scenarios 

Results

  • Access to model architecture and simulation data
  • Visualizations of simulation results
  • Interpretation of data

Methodology

  1. Based on VDI 3633: Clarification of requirements and definition of objectives.
  2. System analysis and data collection.
  3. Model development for process flows.
  4. Implementation of the model in practice.
  5. Verification and validation.
  6. Conducting simulation experiments to analyze different scenarios.
  7. Evaluation and interpretation of results.
  8. Documentation of results.

Additional services

  • GMP production planning 
    Design of GMP-compliant manufacturing processes
  • Feasibility studies 
    Validation study for a new measurement and production technology

Special machine construction: Automated handling and examination of tissue samples

We developed a customized machine for TAORAD GmbH for the automated handling and examination of tissue samples that fully meets the customer's specific requirements. The validated machine was delivered turnkey, including all relevant development and test data.

Client

TAORAD GmbH

Assignment

Turnkey special machine for handling and examining tissue samples 

Results

  • Delivery of a turnkey, validated machine
  • Documentation of all development and test data

Methodology

  1. Based on VDI 2221: Conducting a requirements analysis
  2. Defining the necessary functions and features
  3. Development of possible approaches
  4. Selection and evaluation of solution approaches: analysis and evaluation of solution approaches
  5. Development of an overall solution concept for the machine
  6. Development of the individual modules
  7. Implementation of all modules into a functional overall solution
  8. Conducting tests to ensure functionality and validation of the machine

Additional services

  • GMP production planning
    Design of GMP-compliant manufacturing processes
  • Feasibility studies
    Validation study for a new measurement and production technology

Licensing: Fraunhofer IPT and Harro Höfliger combine expertise for ATMP production plant

Through our cooperation with the machine manufacturer Harro Höfliger from Allmersbach im Tal, we combine our expertise in production research with the machine manufacturer's experience in the construction of high-throughput production facilities. Together, we offer fully automated solutions for the manufacture of ATMPs (Advanced Therapy Medicinal Products) containing living cells or nucleic acids.

Our services range from consulting, analysis, and product development to serial production. This enables us to meet the high standards of quality, safety, and efficiency required in the manufacture of new biotechnological drugs.

Start of cooperation: November 2023

© Fraunhofer IPT
Niels König, Head of the Production Measurement Technology Department at Fraunhofer IPT, and Christian Kollecker, Sales Director Aseptic Technologies Harro Höfliger.

Why you should automate your laboratory processes!

Reducing costs

With our experience in digitizing laboratory processes, we can help you reduce your employees' workload and lower personnel costs: automated systems such as pipetting robots and digital lab notebooks take over repetitive tasks, speed up workflows, and minimize sources of error.

Increasing productivity

Targeted process optimization helps you significantly improve the efficiency of your laboratory processes. Lean processes and fewer errors not only reduce costs, but also enable faster order processing and higher throughput rates, which significantly increases productivity.

Ensuring quality

We work with you to develop comprehensive concepts for networking and digitizing your laboratory processes, enabling end-to-end quality assurance. Precise, automated documentation of all process data and compliance with defined quality standards ensure high purity and consistency of your products.

Scaling therapies

For example, by expanding cells in bioreactors, we enable the cost-efficient production of large quantities of cells for personalized stem cell therapies. Our automated platforms create optimal growth conditions to provide the required cells quickly and efficiently.

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How can you scale up the production of cell-based products while reducing your employees' workload?

Let machines take over routine tasks so your team can focus on the important aspects of product development! In our video, we show you how you can automate manual processes with innovative equipment and procedures.

An international community of experts is forming – are you part of it?

We are currently establishing ICAB – International Community for Advanced Biomanufacturing – a specialist community of companies from the biotechnology and pharmaceutical industries that are working together to make the production of advanced therapy medicinal products (ATMPs) more efficient, resilient, and sustainable.

Kick-off of collaboration

As part of a consortium study, we identify forward-looking topics in biotechnology as well as production technology and regulatory challenges. As the saying goes, "A problem well defined is half solved." These challenges serve as points of reference for the community's development goals.

Take the opportunity to contribute your perspectives and benefit from a lively, collaborative community of experts! Companies from the biotechnology and pharmaceutical industries are invited to actively participate.

Bleiben Sie informiert!

 

What will the laboratory of the future look like?

Read the trend report “Laboratory 4.0 – Next Generation Production in Life Sciences” as a guide to the future of biotechnological production.

 

Follow us on LinkedIn

Connect with us on LinkedIn to learn more about life sciences engineering and stay up to date on the latest news and events.

 

Experience laboratory automation!

Experience automated laboratory systems in test operation and watch our latest videos on YouTube. Experience laboratory automation!

 

Treffen Sie uns auf der nächsten Messe!

Wir freuen uns darauf, Sie persönlich kennenzulernen und gemeinsam über Ihre Projekte zu sprechen.

Contact Press / Media

Kai Janning M.Sc.

Contact person for "Life sciences engineering"

Fraunhofer Institute for Production Technology IPT
Steinbachstr. 17
52074 Aachen, Germany

Phone +49 241 8904-302

Fax +49 241 8904-6302

Contact Press / Media

Dr.-Ing. Bastian Nießing

Contact person for "Bio-adaptive Production"

Fraunhofer Institute for Production Technology IPT
Steinbachstr. 17
52074 Aachen, Germany

Phone +49 241 8904-142

Fax +49 241 8904-6142

Contact Press / Media

Dipl.-Phys. Niels König

Contact person for "Production metrology"

Fraunhofer Institute for Production Technology IPT
Steinbachstr. 17
52074 Aachen, Germany

Phone +49 241 8904-113

Fax +49 241 8904-6113