Get to know our Consortium
Associated Partners
Consortium
acib (Austrian Centre of Industrial Biotechnology)
acib is an international competence centre, developing new, environmentally friendly, economically and technically advanced processes for the biotechnological, pharmaceutical and chemical industry – all of them modelled on nature. acib is bridging the gap between academic research and producing industry. The big advantage for acib partner organisations is the possibility to translate scientific results into concrete processes and products by using scientific know-how, academic infrastructure or industrial networks. Our platform offers tailor-made solutions for our stakeholders from Academia, Industry and Investors. In CAARE acib has the role of coordinator.
Alois Jungbauer
Project Coordinator
Patrica Pereira Aguilar
Project Manager
Project Manager
Verena Beck
Project Manager
Project Manager
Karlsruher Institute of Technology (KIT)
KIT is the Research University in the Helmholtz Association. As one of the biggest science institutions in Europe, the only German University of Excellence with national large-scale research facilities combines a long university tradition with program-oriented top-level research. We seek to contribute to the success of big projects of our society by providing excellent academic education, conducting top-level research, and producing innovations. These big projects cover future energy supply, sustainable mobility, and smart and secure technology for the information era.
Within KIT, MAB (Biomolecular Separation Engineering) belongs to the Institute of Process Engineering in Life Sciences and focusses on all aspects of modern downstream processing. The area of research ranges from accessing structural parameters of proteins on a molecular level, transport and surface interaction phenomena of proteins, purification and characterization of bio-nanoparticles to industrial process development, including real-time process monitoring and control (Process Analytical Technology, PAT). Computational methods are intensively used for data analysis, process modelling and digitalization of processes.
In CAARE, KIT is work package leader of the scientific work package 2 “Process analytical technology, data analysis and modelling” as well as of the work package 4 “Training and Career Development” and will also be involved in training activities. KIT employs two DCs at Campus South in Karlsruhe.
iBET
iBET is a private non-profit Biotechnology Research Organization acting as an interface between academia and industry while also creating and organizing autonomous knowledge and expertise. Target areas are bioprocess development for biopharmaceuticals and advanced therapies, including viral-based gene therapies, cell therapies and vaccines; in-vitro models and methodologies for pre-clinical research and cell therapy applications; and protein stability and structural biology studies for drug design.
iBET’s infrastructure comprises more than 20 R&D laboratories, a GMP certified Analytical Services Unit, a Mass Spectrometry Unit and a Late-Stage R&D and Bioproduction Unit (2000m2). The inauguration of the new iBET Biofarma building in June 2023 added 29 laboratories to its research and analytical platform infrastructures, including one BLS3 Lab. This expertise and facilities, together with a close collaboration with the GMP manufacturer GenIbet (former iBET spin-off), allow iBET to develop integrated solutions from R&D to phase I/II clinical trials, benefiting from access to academic hospitals in Lisbon in oncology (including liver and pancreas), cardio metabolic and neuro sensorial areas.
As an R&D institution, iBET has coordinated over 30 international projects and participated as work-package leader in more than 100 projects supported by the European Commission. iBET has several well-established collaborations in Networks of Excellence and long-term partnerships with international pharmaceutical companies, such as Bayer, Novartis, Merck, Abbvie, Sanofi, Glaxo-Smith-Kline and Boehringer Ingelheim.
Cristina Peixoto
Akedemisch Ziekenhuis Leiden
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University of Hamburg
At Uni Hamburg, we will develop novel nanofluidic devices integrated with sensors to characterize the nanoparticles one by one.
Irene Fernandez-Cuesta
Franziska Esmek
Icosagen Cell Factory OU
Icosagen Cell Factory OU, founded in 2005, serves as the research and development division of the Icosagen Group. Over the years, we have evolved into a comprehensive mammalian Contract Research, Development, and Manufacturing Organization (CRDMO) for the biopharmaceutical, biotechnology, and diagnostic industry. We provide customized services that span the entire development pipeline, from discovery and hit-to-lead identification to pre-clinical candidate selection and early clinical candidate development. This entails antibody and protein discovery, including complicated proteins, their recombinant production, up to stable cell line development and large scale GMP manufacturing on site. In the CAARE project, we develop methods for the production of enveloped lipid bionanoparticles aimed at higher productivity and reduction of host cell impurities, as well as technologies for in vivo incorporation of specific RNAs into bionanoparticles.
Andres Männik
Friedrich Alexander University Erlangen-Nürnberg (FAU)
The Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) is a full-spectrum university with around 40,000 students and over 300 degree programs, which is organised in five faculties. A particular strength at FAU is the close interaction between the Faculty of Engineering and the Faculty of Sciences, which has been the basis for the excellent research infrastructure developed in the last two decades.
At the Institute of Particle Technology (LFG) at FAU we focus on the top-down and bottom-up production and handling of disperse systems and the associated measurement technology for their in-depth characterization. Objectives are the development of new processes and the optimization of already existing ones for functional particle systems and macromolecules. In order to realize products with tailored properties or processes for their production, a direct control of the desired macroscopic product properties via the microscopic structure of the material and its disperse properties is required. The LFG has comprehensive expertise in characterizing the chemical and physical properties of particles and macromolecules and is closely related to the Erlangen Center for Functional Particle Systems (FPS). The FPS targets the development of innovative methods and processes to generate, formulate and apply particles (building blocks) with tailored size, shape and structure as well as customized surface properties. Based on the cross-sectional topic of particles, FPS brings together chemical engineering, materials science, chemistry, physics and life sciences.
In CAARE we target the multidimensional characterization of bionanoparticles (e.g., AAV gene-therapy vectors and VLPs) using a toolset of different analytical ultracentrifugation techniques, which are complemented by other sizing techniques such as nanoparticle tracking analysis and dynamic light scattering. Experimental characterization will be combined with modelling tools such as Brownian dynamics or bead modelling to predict transport properties, validate experimental results and provide operation parameters for (semi-)continuous flow ultracentrifuges.
Wolfgang Peukert
Johannes Walter
ASSOCIATED PARTNERS
Roche
A healthier future. That’s what drives us. And as the world evolves, so do we. For over 125 years, we have taken on some of the most complex challenges in healthcare. Listening and responding to the ever-changing needs of people around the world. We focus on the long-term, leading investment in research and development, striving to improve lives today and for generations to come.
We’re advancing science to ensure everyone has access to the healthcare they need. Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. But we can’t do it alone. To succeed we collaborate – with each other, with our partners, with governments, with patients. Proud of what we do, we’re here because we care.
Our work creates a future where we all have more time with the people we love. That’s what makes us who we are. That’s what makes us Roche.
Christoph Gstöttner
AGES
The Austrian Medicines and Medical Devices Agency (MEA), a business division of the Austrian Agency for Health and Food Safety (AGES), together with the Federal Austrian Office for Safety in Health Care (BASG), represents the National Competent Austrian Authority for Medicines, Medical Devices, Blood and Tissue, responsible for drug approval, clinical trials of drugs and medical devices, pharmacovigilance and vigilance in the field of medical devices and inspection in Austria. AGES MEA/BASG is one of the leading regulatory agencies for medicinal products and medical devices within the European Network. This results in extensive knowledge and expertise for development (scientific advice & clinical studies) of medicinal products and approval of (national-, decentralized and centralized procedures) and life cycle (variations, quality control, official control authority batch release, pharmacovigilance, safety assessment) of medicinal products.
AGES will contribute the regulators’ view and will be partner in the dialog for the up-coming continuous manufacturing regulation. In particular, AGES will be involved in the network-wide training program by delivering a training on regulatory aspects of cell and gene therapy. Planned course shall give an overview on the regulatory framework, on the discovery, development and manufacturing of biopharmaceuticals. Open regulatory issues in the context of bionanoparticle-based therapies will be addressed.
Manfred Schuster
Phoenestra
Phoenestra is a start-up company focusing on the development of technology platforms for stem cell-derived products. Based on these platforms, cell- and vesicle-based products can be defined and manufactured consistently for research or therapeutic applications. Recently, the EVscaleTM platform has been launched for scalable manufacturing of clinical-grade extracellular vesicles (EV) from stable telomerized Mesenchymal Stem/Stromal cells (MSC/TERT).
Klaus Graumann
NOVA University Lisbon
NOVA University Lisbon is a public university created in 1973, hosting more than 20000 students, 1800 teaching and research staff, and 41 Research Units, distributed by 9 Academic Units in the metropolitan area of Lisbon. The Instituto de Tecnologia Química e Biológica António Xavier (ITQB NOVA) is an Academic Unit of NOVA whose mission is to carry out scientific research and postgraduate teaching in life sciences, chemistry, and associated technologies while serving the community and promoting science and technology. ITQB NOVA has strong expertise in Molecular Biosciences – including Cellular, Molecular, and Structural Biology, Biotechnology and Chemical Biology. This expertise drives research with an impact in strategic challenges: the well-being of human societies and the environment. ITQB NOVA coordinates two FCT-funded Research Units – MOSTMICRO-ITQB and GREEN-IT – and is involved in a third – iNOVA4HEALTH, all rated Excellent by the FCT. Researchers benefit from first-rate equipment, research facilities, and support services to carry out competitive research. Currently with approx. 54 independent labs, it hosts approximately 500 researchers. With a track record of scientific excellence and a focus on internationalization, ITQB NOVA is a leading center for advanced researcher training that is also part of the Associate Laboratory Life Sciences for a Healthy and Sustainable Future (LS4FUTURE) which is among the top-rated Associate Laboratories in Portugal.
Cristina Peixoto
BOKU University
BOKU has trained several thousands of scientists in the area of Biotechnology since the establishment of the respective curriculum in 1945. Currently approximately 800 students are enrolled in the BSc and MSc programs on this topic and approximately 100 students are working on their PhD. BOKU training consists of a balanced combination of theory and lab work and aims at complementary expertise in chemistry, biology and bioprocessing for its students.
Reingard Grabherr
Genibet – Biopharmaceuticals SA
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Viralgen Vecor Core, S.L.
Viralgen is a fully integrated Contract Development and Manufacturing Organization (CDMO) founded in 2017 and operating as an independent subsidiary of Asklepios Biopharmaceutical, Inc. (AskBio), part of the Bayer AG group. Viralgen was created to support every stage of AAV therapeutic development from proof-of-concept to commercial manufacturing. Through the AskBio licensed proprietary Pro10™ suspension manufacturing platform, Viralgen delivers industry-leading titer and quality for all AAV serotypes, optimizing speed to market and cost-of-goods to accelerate clinical development and commercialization.
Based in San Sebastian, Spain, Viralgen’s state-of-the-art facilities support development, manufacturing and release of gene therapies at scales up to 2,000L under multiple clinical and commercial licenses granted by the Spanish Agency for Medicines and Medical Devices (AEMPS) as part of the EMA for the manufacture of human medicinal products, investigational medicinal products and sterile or biological active substances. From a deep foundation in AAV manufacturing expertise, Viralgen continues to build a broad offering of support for gene therapy developers, recently inaugurating a new MSAT facility to support customers moving to commercial launch and a development lab to help improve manufacturability and expression of new gene therapy programs. These new offerings complement their established capabilities in research, development, manufacturing and quality control that have made them a leading gene therapy CDMO.
César Trigueros
María Iglesias González
Alfa Wassermann Separation Technologies BV
Alfa Wassermann Separation Technologies BV, a subsidiary of Alfa Wassermann Inc., for over 60 years the supplier whose singular purpose has been the support of bioprocess and pharmaceutical industries by providing expertise in continuous flow ultracentrifugation separation applications, fluid management solutions, and process monitoring.
Alfa Wassermann will provide our expertise in supporting post-doctoral candidates development of continuous flow ultracentrifugation applications for purification of nanoparticles and nanostructures.
Sandra Merino
SimVantage
SimVantage has succeeded in developing software that makes it possible to simulate and consequently optimize gassed and/or stirred bioreactors. Bioreactors are needed, for example, to produce modern drugs such as antibiotics, monoclonal antibodies for cancer therapy or vector vaccines. They can also be used to produce clean meat, food additives or for precision fermentation. With the knowledge gained from the software, the transition from laboratory to production and, thus, the time to market is significantly shortened. This helps to save time and money, from which the general public can also benefit.
Christian Witz
ArcticZymes
ArcticZymes Technologies is a biotechnology company with over 30 years of experience in enzyme development for biomanufacturing. The company offers a portfolio of specialized enzymes derived from cold-adapted extremozymes, designed to function under demanding process conditions.
ArcticZymes is the originator of salt-active nucleases, enabling efficient degradation of DNA and chromatin in high-salt and complex biological matrices. Addressing chromatin as a key impurity supports improved downstream processing and facilitates more consistent purification of bionanoparticles.
Within CAARE, ArcticZymes contributes to improved downstream processing through early chromatin degradation, reducing process complexity and supporting more efficient purification of therapeutic bionanoparticles.
Jørn Henriksen
BioChromatographix International (BCI)
BCI was founded in Singapore to address the increasing demand for Next-Generation Monolithic Chromatography Media. BCI is focusing on downstream processing with a new class of next-generation monolithic chromatography media for gene therapy, cell therapy, and advanced biologics manufacturing. With a focus on performance, scalability, and material innovation, BCI is enabling the next wave of cell and gene therapy manufacturing through advanced flow architecture and industry-leading purification. They would provide material with features specifically designed for viral vector and virial vaccine purification and analytics. BCI would provide chromatography material and their expertise in viral vector and plasmid purification. With access to the material CAARE doctoral candidates will get acquainted with the next generation of separation technologies.
Chervee Ho