Researchers at the NMI (Natural and Medical Sciences Institute) of the University of Tübingen in Germany are using the Viscotek TDAmax GPC/SEC triple detection system with Omnisec software, both from Malvern Instruments, in their analysis of biomaterials.
Mixtures of different polymers and biopolymers are used in the production of the degradable biomaterials that are the foundation of modern carrier matrices for regenerative medicine. With such applications in human medicine, comprehensive GMP- and GLP- compliant quality control of such polymer blends is becoming increasingly important.
The chromatographic separation of different polymer components using SEC and subsequent triple detection provides an excellent opportunity to obtain a comprehensive picture of the molecular weight and molecular size of different polymers in a single step.
Prof. Dr. Dieter Stoll, director of quality control at NMI Technology Transfer GmbH, is convinced: "The Viscotek TDAmax system with refractive index (RI) detector, UV diode array detector, viscosity- and light scattering detector allows us to characterize heterogeneous mixtures of materials, from polysaccharides to proteins and small molecules, quickly and efficiently. Viscotek's technology is complementary to the other methods used at the institute, such as MALDI-TOF-MS or HPLC-ESI-mass spectrometry. We already use other material characterization systems (Zetasizer Nano, Kinexus rheometer) from Malvern and have always had very good experience with the support of Malvern’s applications laboratories and the training that the company provides."
The NMI conducts applied research and development at the interface of biotechnology and materials science. Core competencies are in the pharmaceutical and biotechnology, biomedical engineering, surface and interface technology areas. With strong interdisciplinary working groups, the NMI works with national and international projects in close collaboration with basic research groups, hospitals and companies. The more than 150 employees of the NMI see themselves as intermediaries between academic research and industrial application. The implementation of new findings from science into commercially viable products or processes is the challenge that the NMI has managed successful for 25 years. NMI Technology Transfer GmbH is a subsidiary of NMI, where testing and manufacturing services are bundled in the NMI’s accredited and certified areas.
Thus, the NMI offers its customers an integrated service from joint research and development projects to internationally usable, pivotal trials for medical devices and medicines. A manufacturing license is planned by mid-2010 for GMP-compliant testing in the production of biomaterials as components of advanced therapy medicinal products. It is intended that the TDAmax system, the Kinexus rheometer and the Zetasizer Nano from Malvern will be set up as part of this area.
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