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Sartorius Stedim BioOutsource Contract Testing Facility in Glasgow Successfully Passes FDA Inspection
Certified quality of analytical services for developers of biologics and biosimilars
Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, is pleased to announce that the Glasgow facility of its subsidiary Sartorius Stedim BioOutsource Ltd. has successfully passed an inspection by the U.S. Food and Drug Administration (FDA).
In January 2016, the FDA Compliance Safety Officer spent two days at BioOutsource’s facility reviewing its quality systems and their application to the analytical services that support the testing of biologics, vaccines and biosimilars. The inspection confirmed that the Glasgow site is compliant with the principles and guidelines of Good Manufacturing Practices (GMP). Not a single Form 483 observation for non-conformance was issued.
At the closing meeting, the FDA inspector was very satisfied with the facility and complimented Sartorius Stedim BioOutsource on its GMP systems, organisation during inspection and the expertise of its team members. The success of this FDA inspection, combined with the positive feedback from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2015, as well as reports from numerous biopharma clients that have visited and audited the Glasgow facilities in recent years, demonstrates BioOutsource’s commitment to maintaining excellence in its quality systems.
Sartorius Stedim Biotech and GE Healthcare sign worldwide OEM supply agreement
Expands GE’s start-to-finish offering for cost efficient manufacture of biopharmaceuticals | Increases global access to SSB’s innovative purification technology
Sartorius Stedim Biotech, a leading international supplier for the biopharmaceutical industries and GE Healthcare’s Life Sciences business, a provider of start-to-finish enterprise solutions, technologies and services for biopharmaceutical manufacturing, today announced they have entered into a worldwide OEM supply agreement for Sartorius Stedim Biotech’s innovative membrane adsorber purification technology, Sartobind™. Under the terms of the agreement, SSB will manufacture membrane adsorber technologies for GE which will be marketed as part of GE’s ReadyToProcess™ product offerings. Membrane adsorber ion-exchange technology is widely used in the industry for the removal of contaminants such as endotoxins and viruses during the production of protein-based drugs, and can offer manufacturers advantages compared to other techniques. Financial terms were not disclosed.
Goldman Sachs European Medtech Conference in London, UK September 9, 2015
Morgan Stanley Global Healthcare Conference in New York, USA September 17, 2015
Publication of nine-month figures for 2015 October 20, 2015
Société Générale Healthcare Conference in Paris, France November 5, 2015
Publication of preliminary figures for fiscal 2015 January 2016
Annual Shareholders' Meeting in Aubagne, France April 5, 2016
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