Pooling expertise: Fraunhofer IPT and Harro Höfliger cooperate in the manufacturing of ATMP production systems

Niels König, Abteilungsleiter Produktionsmesstechnik am Fraunhofer IPT, und Christian Kollecker, Sales Director Aseptic Technologies Harro Höfliger. © Fraunhofer IPT / Niels König, Head of Production Metrology Department IPT and Christian Kollecker, Sales Director Aseptic Technologies Harro Höfliger. © Fraunhofer IPT

New mRNA vaccines and gene therapeutics have gained media attention as a result of the coronavirus pandemic. These pharmaceuticals, known as ATMP (Advanced Therapy Medicinal Products), contain living cells or the nucleic acids DNA or RNA. Producing such ATMPs in high quality requires customized production facilities and an associated range of services. The Fraunhofer Institute for Production Technology IPT and Harro Höfliger from Allmersbach im Tal are now entering into a cooperation to develop fully automated ATMP production systems: Together, the partners are developing an offer for consulting, analysis and product development through to the serial production of marketable ATMP systems.

The aim of the cooperation between Fraunhofer IPT and Harro Höfliger is to transfer the technical expertise from production research into the production and sale of high-performance individualized medical products. The result is a joint range of efficient systems and associated services that meet the increasing demands on quality, safety and efficiency of the new class of medicines. They are marketed by industry partner Harro Höfliger for the production of ATMPs. The cooperation was launched with the signing of the cooperation agreement on November 14, 2023 in Aachen.

From process analysis and plant development to the finished medicinal product

The tasks of the Fraunhofer IPT within the collaboration primarily include the techno-economic analysis of the processes in cell production: cultivation, differentiation, genome editing, quality control, material transport, filling and storage as well as the evaluation of the automation potential. Scientific studies, the risk assessment of biological production and the development of new software and hardware solutions for ATMP production facilities are all part of the collaboration. The construction of fully automated cell production facilities for the pharmaceutical industry up to pre-series production is also planned in individual cases.

As part of the offer, Harro Höfliger transfers the development work to the series construction of the systems. The aim of the cooperation partners is to set up GMP-compliant production systems for the high-throughput production of a wide range of pharmaceuticals and medicinal products. As an industrial partner, Harro Höfliger takes over worldwide sales and customer support as well as maintenance services for the individual machines at the end customer.

Many years of experience in the integration of production technologies in the life sciences

The Fraunhofer IPT has been conducting research in the field of automated cell cultivation for more than 12 years and has decades of experience in the design and development of special machines. The know-how from successful research projects, such as "StemCellFactory", in which industry-ready automated system prototypes for pharmaceutical drug development were built, flows directly into the cooperation. Other current research and development projects at the Fraunhofer IPT are investigating the automation of the production of new gene and cell therapeutics, such as those required for the treatment of blood cancer or osteoarthritis.

As an international company based in Baden-Württemberg, Harro Höfliger specializes in the development and construction of high-throughput production systems for pharmaceuticals and medical devices for the pharmaceutical industry. The company also contributes its extensive experience in Good Manufacturing Practice (GMP) and clean room production to the cooperation.

Cooperation between research and industry brings added value for pharmaceutical companies and patients

Niels König, Head of the Production Metrology department at Fraunhofer IPT, is looking forward to the collaboration: "With this joint offering, we are creating real added value for ATMP production: our technical expertise and excellent research performance at the cutting edge will flow directly into the implementation of marketable and serial products that will be available worldwide".

Christian Kollecker, Sales Director Aseptic Technologies at Harro Höfliger, focuses on the customers: "Customers from the pharmaceutical industry benefit from the cooperation throughout the entire development and production process. From individual consultation and analysis of their requirements for ATMP production machines through to support and sales after installation, we support them in every phase."

Christian Kollecker, Sales Director Aseptic Technologies at Harro Höfliger, and Bastian Nießing, Group Leader Automation in the Life Sciences at the Fraunhofer IPT, will be happy to answer any further questions you may have about the cooperation.