Newsletter_03-2024_EN

Pooling expertise: Cooperating in the
manufacturing of ATMP production systems
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 pharmaceuti-
Niels König, Head of Production Metrology Department IPT
and Christian Kollecker, Sales Director Aseptic Technologies
Harro Höfliger. © Fraunhofer IPT
cals 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 „Stem-
CellFactory“, 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.
Fraunhofer-Institut für Produktionstechnologie IPT
D 52074 Aachen
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