Malvern Kinexus Installed in New GMP Testing Facility at NMI Reutlingen
Used for biomaterials characterization in field of regenerative medicine
Malvern, UK: Researchers at the Natural and Medical Sciences Institute (NMI) at the University of Tübingen in Germany have installed a Kinexus rheometer from Malvern Instruments in the new GMP testing facility at its subsidiary, NMI Technologietransfer GmbH. The Kinexus is used primarily for the characterization of biomaterials, mainly hydrogels containing patient cells. Such hydrogels are used as a stabilizing 3D-matrix for innovative cell therapeutics in the exciting field of regenerative medicine, targeting for example the regeneration of articular cartilage, spinal discs and injured nerves.
Regenerative medicine is a core competence and a key focus for various research groups within the NMI. The advent of new and more stringent regulation of the materials used in regenerative medicine now subjects them to controls similar to those applied for pharmaceutical products. To meet the need for pharmaceutical-type testing, NMI has established a new GMP facility at its subsidiary, NMI Technologietransfer GmbH, to enable the fully regulated testing both of regenerative materials and the biomaterials necessary for their delivery.
Professor Dr. Dieter Stoll, head of quality control in the new GMP facility, is particularly pleased with the support provided by the Malvern team who recently ran a workshop specifically for the five people who will be regular users of the Kinexus. "Our users range from people who are very experienced to others who are not expert rheologists, so some were initially a little nervous about using the rheometer," he said. "However, the workshop was perfect. Everyone was able to go to the machine and use it, gain confidence and discuss different items with the Malvern team."
Kinexus is a unique rheometer from Malvern Instruments designed to meet rheology needs across a wide variety of research sectors, industries and application areas, for users at every level of experience. It enables precise analysis of the rheology of materials: from liquids to soft solids, processability to product performance, temperature to time dependence. www.malvern.com/kinexus
Malvern, Malvern Instruments and Kinexus are registered trademarks of Malvern Instruments Ltd
NOTE:*"Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
About Malvern Instruments
Malvern Instruments is a market leader in measuring performance controlling material properties. These include particle size, particle shape, zeta potential, molecular weight, size and conformation, rheological properties and chemical distribution. Malvern delivers the systems, support and expertise that ensure the analytical integrity and productivity needed to drive research, development and manufacturing.
Malvern's measurement solutions for scientists, technologists and engineers advance continually through customer collaboration. Complementary materials characterization systems deliver inter-related measurements that reflect the complexities of particulates and disperse systems, nanomaterials and macromolecules. Combining intelligently implemented technologies with in-depth industry applications knowledge and support, Malvern provides customers with the competitive advantage they demand.
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. www.malvern.com
About NMI and NMI Technologietransfer GmbH
The NMI Natural and Medical Sciences Institute at the University of Tuebingen, located in Reutlingen, Germany, conducts applied research and development at the interface of life sciences and materials science for 25 years now. More than 150 employees are working in a strongly interdisciplinary environment at the cutting edge between academic research and industrial applications. The NMI holds an accreditation according to DIN EN ISO 17025 for various physico chemical analyses. The NMI Technologietransfer GmbH is a subsidiary of NMI, where main testing and manufacturing services in the certified areas of GMP or GLP are bundled. Drug testing by safety pharmacology studies under GLP as well as quality controls of biomaterials and advanced cell based therapeutics under GMP were established within recent years. The NMI is an innovative and reliable partner for pharmaceutical and biotech companies worldwide, offering an integrated service from joint research and development projects to pivotal trials for medical devices and medicines and customer specific analytical services in the regulated environment of pharmaceutical and medical devices industries.
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