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Sartorius Stedim BioOutsource Contract Testing Facility in Glasgow Successfully Passes FDA Inspection

Sartorius Group

Certified quality of analytical services for developers of biologics and biosimilars

2 Mar 2016
Lois Manton-O'Byrne, PhD
Executive Editor

Industry news

Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, has announced 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, organization 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.

Gerry Mackay, CEO at BioOutsource stated: “We’re delighted with the positive outcome of our FDA inspection, because it shows that we are committed to offering quality analytical and safety testing. This provides biopharma firms with confidence that we are a partner they can trust with their biologic and biosimilar drug development programs.”

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RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.Laboratory ManagementLaboratory management involves overseeing the operations of a lab, ensuring compliance with safety regulations, optimizing workflows, and maintaining equipment. Efficient lab management is key to ensuring accurate results and minimizing downtime. Technologies like laboratory information management systems (LIMS) and automated lab equipment are helping labs streamline operations. Browse our peer-reviewed product directory to find the best laboratory management tools, compare products, read reviews, and get pricing directly from manufacturers.Laboratory SafetyLaboratory safety is essential to the effective operation of all laboratories and is required to minimize the risk of harm during experiments. Guidelines, regulations, and equipment should be available in all laboratories to ensure that the working environment is safe and secure.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.BiosimilarsBiosimilars are very similar versions of approved and authorized medicines. Clinically inactive components will have minor differences, but there are no significant differences between the biosimilar and the original product in terms of potency, purity and safety.BiologicsBiologics are medical products derived from living organisms, including vaccines, gene therapies, and monoclonal antibodies. These treatments are key to modern healthcare, especially in oncology and autoimmune diseases. Explore biologics research tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Vaccine DevelopmentVaccine development focuses on creating immunizations to protect against infectious diseases. The process involves identifying antigens, developing and testing vaccine efficacy, and ensuring safety through preclinical testing and multiple clinical trial phases. Scientists use various approaches, including weakened or inactivated viruses, protein subunits, or mRNA. Advanced platforms and rapid diagnostic tools aid in vaccine research and testing. Explore vaccine development solutions in our peer-reviewed product directory; compare products, read reviews, and get pricing directly from manufacturers. ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.

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