GPC/SEC Triple Detection Allows Comprehensive Analysis of Biomaterials

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

13 May 2010; Malvern, UK: 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.

About Malvern Instruments
Malvern Instruments provides a range of complementary materials characterization tools that deliver inter-related measurements reflecting the complexities of particulates and disperse systems, nanomaterials and macromolecules. Analytical instruments from Malvern are used in the characterization of a wide variety of materials, from industrial bulk powders to nanomaterials and delicate macromolecules. A broad portfolio of innovative technologies is combined with intelligent, user-friendly software. These systems deliver industrially relevant data enabling our customers to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging).

Particle size, particle shape, zeta potential, molecular weight, chemical composition and rheological properties measurements are now joined by advanced chromatography solutions (GPC/SEC), extending Malvern's technologies for protein molecular weight, size and aggregation measurements, and synthetic polymer molecular weight and distribution. The company's laboratory, at-line, on-line and in-line solutions are proven in sectors as diverse as cement production and pharmaceutical drug discovery.

Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Korea and Japan, a joint venture in India, a global distributor network and applications laboratories around the world.

About NMI
Within the NMI TT GmbH, certified methods are applied for the registration of medical devices and pharmaceuticals for novel therapies, chemical treatment (eg, Ellman test) and physical examination (UV / VIS, FTIR, HPLC-ESI-MS, gel permeation chromatography, rheometry) of novel biomaterials such as drug carriers in cell-based medicines. In addition, investigations of the surface properties of medical devices using biological methods for the investigation of hemocompatibility (Chandler loop, in-vitro pyrogen test) and various electrochemical methods for measuring degradation products (polarography, voltammetry, and potentiometry) are performed.

In the area of pharmaceutical services, the NMI offers drug screening on ion channels and pre-clinical safety pharmacology according to FDA and EMEA guidelines, as well as ion channel assays at the single cell level (manual and automated patch clamping, oocyte screening), assessment of organ preparations (papillary muscle, Langendorff heart, isolated organs) and non-GLP and GLP analysis of the human hERG potassium channel.

Bioanalysis at the NMI deals with analysis of

o Natural materials such as proteins, peptides, oligonucleotides, lipids, oligosaccharides and low molecular weight metabolites
o Synthetic drugs
o Chemical additives and contaminants

For the various tasks innovative chromatographic or electrophoretic separation methods are used, which are combined with different detection methods (ELSD, fluorescence, UV, ESI-MS), to be able to provide rapidly meaningful results for customers and partners.

For press information, please contact:
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USA contact:
Marisa Fraser, Malvern Instruments Inc.
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Tel: +1 508 768 6400 Fax: +1 508 768 6403

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