Fraunhofer Institute for Cell Therapy and Immunology IZI
Fraunhofer Institute for Cell Therapy and Immunology IZI

GMP Cell and Gene Therapy

Social media campaign "Our GMP Experts"

Two cleanroom technicians in full sterile protective suits and face masks stand in a bright, high‑tech laboratory surrounded by equipment; overlaid text reads “#WeKnowGMP” and “Tina & Maxim – Manufacturing Operators,” with the Fraunhofer logo in the upper right corner.
© Fraunhofer IZI

Manufacturing Operators

 

Meet Maxim and Tina – two of our dedicated manufacturing operators who play a crucial role in the production of cell-based investigational medicinal products. At Fraunhofer IZI, their work requires precision, teamwork and an unwavering commitment to excellence. In this highly controlled environment, production is always carried out by two people working together to ensure mutual support, thorough oversight and full compliance with Good Manufacturing Practice at every stage. Our operators set themselves apart through specialized training, continuous professional development, and extensive hands-on experience. This combination of skill and dedication guarantees the highest standards of product quality and patient safety.

Qualified Person

 

Kati is one of four Qualified Persons in the department GMP Cell and Gene Therapy at Fraunhofer IZI who meets the requirements of section 15 of the German Medicines Act for ATMPs. In this role, she confirms that all in the department manufactured ATMPs adhere to the high quality standards and regulatory requirements. Before a product can be used clinically, Kati performs batch certification – a crucial step that ensures patient safety. As the final instance for batch record review and decision-making, she confirms that manufacturing and quality control are strictly carried out in accordance with good manufacturing practice principles and the applicable regulations. This task requires in-depth expertise in cell and gene manufacturing and analytical testing and regulatory knowledge as well a high level of precision. All our Qualified Persons embody these values and have many years of experience in the manufacture and quality control of cell-based therapeutics.

A professional with shoulder‑length light hair sits at a bright office desk with computer monitors, paperwork, and a potted plant near large windows, while a teal overlay shows the Fraunhofer logo, the hashtag “#WeKnowGMP,” and the words “Qualified Person” alongside the employee’s name Kati Kebbel.
© Fraunhofer IZI
A person with shoulder‑length reddish hair stands with folded arms between tall shelves in a bright, modern workspace; a teal overlay at the bottom displays the hashtag “#WeKnowGMP” and the text “Head of Quality Assurance,” while the Fraunhofer logo appears in the upper right corner.
© Fraunhofer IZI

Head of Quality Assurance

 

As Head of Quality Assurance, Anja plays a central and dynamic role at Fraunhofer IZI. Through her proactive approach to quality management, she ensures the consistent quality of all investigational medicinal products produced at Fraunhofer IZI. She is responsible for maintaining and continuously improving our comprehensive quality system in accordance with good manufacturing practice (GMP), as well as for identifying, evaluating and minimizing potential risks to product integrity and patient safety. Anja's mission is clear: To ensure that every pharmaceutical product manufactured at Fraunhofer IZI is safe, effective and of the highest quality, while complying fully with all regulatory requirements.

Quality Control Operators

 

Quality control is the central tool for monitoring the success of every pharmaceutical manufacturing process and for the final release of products. At Fraunhofer IZI, Tom and his colleagues ensure that all cellular raw materials, intermediate products and final investigational medicinal products meet the highest quality standards. They perform sophisticated molecular biological, immunological, cell-based and microbiological tests using advanced analytical methods. Their work also involves developing, implementing and validating analytical procedures, as well as ensuring accurate and transparent documentation at every stage. The data generated by quality control forms the basis for product release by the Head of Quality Control and the Qualified Person – it provides the scientific certainty behind every release decision and every dose.

Quality control operator Tom stands with folded arms in a white lab coat in a bright, modern laboratory filled with scientific equipment, while the Fraunhofer logo appears in the top right corner and the slogan “#WeKnowGMP” is displayed across the lower part of the image.
© Fraunhofer IZI
A person in a teal lab hoodie stands in a well‑lit storage room between metal shelves filled with labeled plastic containers, while a teal graphic overlay at the bottom shows the Fraunhofer logo, the hashtag “#WeKnowGMP,” and the role “Material Management.”
© Fraunhofer IZI

Material management

 

Astrid plays a key role in ensuring that all GMP manufacturing processes at Fraunhofer IZI run smoothly. She is responsible for managing material supply and advance planning, including material budget control for all production activities. She ensures that all raw materials and consumables are available as and when needed for the GMP-compliant manufacture of cell and gene therapies. Astrid coordinates and documents every step of the supply chain with great attention to detail, and proactively monitors inventory levels in close cooperation with our customers.

Clinical Operations

 

Andreas and his team ensure that cellular starting materials, such as apheresis products, and finished products, such as CAR-T cells, arrive in the right place at the right time, under strict, validated transport conditions. They work closely with customers, clinical sites and specialized logistics partners around the world at Fraunhofer IZI. This task is of critical importance, as cell and gene therapy products are highly sensitive and time-critical. Any deviation from these conditions could compromise product quality and patient safety. Thanks to precise planning, careful monitoring and seamless communication, Andreas and his team ensure that every shipment reaches its destination safely and on time.

A laboratory professional in a white Fraunhofer‑branded lab coat stands in a bright clinical workspace with stainless‑steel equipment in the background; a teal graphic overlay shows the hashtag “#WeKnowGMP” and the text “Andreas – Clinical Operations,” with the Fraunhofer logo in the upper left corner.
© Fraunhofer IZI
Three professionals stand together in a bright laboratory setting, partially covered by a teal banner that reads “#WeKnowGMP” and “Sina, Caroline & Sandra – Head of Manufacturing Devices and Clean Room Monitoring / Head for Software and Devices Quality Control,” with the Fraunhofer logo in the top right corner.
© Fraunhofer IZI

Head of Manufacturing devices/clean room monitoring + Head for Software and Devices Quality Control

 

Behind the scenes at Fraunhofer IZI, Sina, Caroline and Sandra and their teams ensure that everything runs flawlessly. As facilities and technical operations specialists in manufacturing and quality control, they ensure that all equipment, devices and software are available, functional and fully compliant. They coordinate the maintenance, calibration and qualification of all technical systems, ensuring reliability and precision at every stage. By keeping complex systems operating seamlessly, they play a vital part in ensuring that all production processes and quality control activities meet the highest standards of consistency and safety.

Head of Manufacturing

 

Robert plays a crucial role in ensuring that GMP compliance is maintained during ongoing production campaigns at Fraunhofer IZI. He ensures that every product meets the strict quality standards required for patient use. He reviews the manufacturing section of the batch record and releases it for review and certification by the Qualified Person. Robert also evaluates deviations and defines corrective and preventive actions (CAPA) to ensure continuous compliance and improvement. Beyond ensuring regulatory compliance, he drives progress by identifying opportunities to make production more efficient, robust and cost-effective. He combines precision, quality and innovation in his work, ensuring that every step in the manufacturing process contributes to the production of safe and reliable therapies for patients.

A person in a dark blue sweater stands with folded arms in front of large windows looking into a bright clean room facility with scientific equipment, while a teal overlay at the bottom shows the Fraunhofer logo, the hashtag “#WeKnowGMP,” and the text “Robert – Head of Manufacturing.”
© Fraunhofer IZI
A person in a white lab coat with blonde hair sits in a laboratory. The background shows high-tech laboratory equipment. A teal graphic overlay shows the hashtag “#WeKnowGMP” and the text “Juliane – Head of Quality Control – Methods,” with the Fraunhofer logo in the upper left corner.
© Fraunhofer IZI

Head of Quality Control – Methods

 

Juliane is responsible for driving innovation and precision in quality control of cell-based products at Fraunhofer IZI. She is responsible for optimizing and implementing precise and accurate analytical methods that meet European Pharmacopoeia requirements. By issuing the Certificate of Analysis she confirms GMP compliant testing and product quality of each cell-based product. Juliane's in-depth scientific and technical expertise enables her to support the seamless transfer of laboratory methods into the regulated GMP environment, as well as designing intelligent strategies for validation of these methods. She bridges the gap between research and the regulated GMP environment, ensuring that every analysis result contributes to the development and manufacturing of safe, effective and high-quality therapies for patients.

Project Manager

 

As one of our project managers, Susann ensures that GMP projects at Fraunhofer IZI run smoothly from start to finish. She plans, manages and coordinates our customers' defined processes with precision and dedication. Acting as the central point of contact between production, quality control, quality assurance, and all technical and regulatory functions, she ensures that all aspects are coordinated and run according to plan. She oversees project-related risk management, reporting and customer communication to ensure transparency, quality and GMP efficiency at every stage. Thanks to her structured approach and strong coordination skills, complex requirements are translated into successful outcomes, ensuring projects run smoothly and deliver exceptional results.

A friendly, confident woman with short blonde hair stands with arms crossed in a modern office environment. She wears a teal-green top and is positioned near large windows with natural light. In the background, colleagues are chatting. A teal overlay shows the Fraunhofer logo, the hashtag “#WeKnowGMP,” and the words “Project Manager” alongside the employee’s name Susann.
© Fraunhofer IZI