Biosafety Testing

Biosafety Testing
Product Description

Life-saving medicines are heavily regulated during development, manufacture and distribution. To fulfill regulatory requirements, the biopharmaceutical industry is increasingly looking for independent service providers who can deliver comprehensive characterization solutions on one site. 
SGS’s global center of excellence for cell bank characterization & virus testing is located in the United Kingdom and provides services with ultimate reliability, highest GLP/cGMP quality & scientific expertise. 
As trailblazers in the development of the biosafety testing industry, our team in Glasgow have developed and validated novel nucleic acid technologies, such as real-time PCR, RAPD, Sequencing, Non radioactive Southern Blotting, Next Generation Sequencing (NGS). For any of your biologics, we help you comply with the global regulatory guidelines and testing requirements.

SGS Group Management SA

  • CH
  • 2020
    On CPhI since
Other
Specifications
  • Supplied from
    United Kingdom

SGS Group Management SA

  • CH
  • 2020
    On CPhI since
Other

More Products from SGS Group Management SA

  • Nitrosamine Impurities Testing

    Product Nitrosamine Impurities Testing

    SGS Life Sciences has considerable expertise in the method development of nitrosamine determination in pharmaceutical products. SGS has established a specific method for NDMA which can be applied to various different matrices. Alternatively, a platform method, based on trace-level detection by LC-MSMS, is also available and provides rapid and simultaneous determination of up to ten different, targeted nitrosamines. Although with more limited application, the SGS network is also able to support specialist methodologies such as GC-MSMS. Our experience in optimizing extraction procedures allows application of these methods to drug products, API’s, and raw materials. 
  • Extractables & Leachables

    Product Extractables & Leachables

    Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging. Regulatory bodies such as the US Food and Drug Administration (FDA) and The European Medicines Agency (EMA) are increasingly focussing on the interactions between various manufacturing components (such as single use systems), drug delivery devices and container-closure systems, and the finished pharmaceutical product. 

    SGS offers tailored study design and testing for extractables and leachables in finished pharmaceutical packaging, process equipment, and medical devices and leachables in final products.

  • Quality Control Testing

    Product Quality Control Testing

    Bringing a compound from the laboratory to the market is a long and winding road with a great number of scientific, safety and regulatory challenges. SGS has been offering high quality analytical testing and clinical research services to support drug research, registration and production. 
    SGS leverages its conveniently located network of laboratories and clinical trial facilities present in North America, Europe and Asia-Pacific, to deliver harmonized solutions to large pharmaceutical and biotechnology firms.


     Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services. We perform a variety of tests that are bespoke, client-specific and support the full clinical development, from Phase I First-in-Human trials in our Clinical Pharmacology Units to Phase II and Phase III studies in patients.
  • Viral Safety Testing

    Product Viral Safety Testing

    SGS’s global center of excellence for cell bank characterization & virus testing is located in the United Kingdom and provides services with ultimate reliability, highest GLP/cGMP quality & scientific expertise.

    For any of your biologics, we help you comply with the global regulatory guidelines and testing requirements. Our laboratory in Glasgow is a 2,400 m² cGMP/cGLP certified, MHRA and US FDA registered and inspected laboratory.

    As trailblazers in the development of the biosafety testing industry, our team in Glasgow have developed and validated novel nucleic acid technologies, such as real-time PCR, RAPD, Sequencing, Non-radioactive Southern Blotting, Next Generation Sequencing (NGS).

    We offer a comprehensive range of integrated solutions, including biosafety testing & characterization of raw materials, cell bank & virus seeds, unprocessed bulks/viral harvests and drug substance/product.

  • Biologics Charaterization

    Product Biologics Charaterization

    A full package of Biologics testing services to cGMP standards from early phase characterization including Biosafety to Quality Control release testing enabling you to outsource your biologics.
  • Impurities and contaminants analysis

    Product Impurities and contaminants analysis

    Impurities and contaminants analysis in biotechnology products from SGS – a range of services providing impurities and contaminants characterization in biotechnology derived products and microbial contamination control.To help you meet ICH Q6B guidelines, you need accurate impurities and contaminants analysis in biotechnology products during product characterization. We offer a number of services and techniques providing impurities and contaminants characterization in biotechnology derived products.

    As a world-leading provider of impurities and contaminants analysis in biotechnology products, we offer you the experience, technical and regulatory expertise, and unique global network you need. Our services help you to analyze and characterize process-related impurities, product-related impurities, and product-related substances.

    Our solutions include:

    Host cell proteins, host cell DNA, and other process related impurity testing Product related impurities and degradants analysis Detergents and surfactants characterization Fatty acid composition analysis To find out more about our impurities and contaminants analysis in biotechnology products, contact us today.


  • Microbiology Testing

    Product Microbiology Testing

    At SGS, we are leaders in microbiology testing services for quality control, providing a complete array of services for the bio/pharmaceutical industry.The microbiological attributes of pharmaceutical ingredients are often critical to final product quality. 
    FDA expects manufacturers to measure and characterize the microbial quality of their pharmaceutical substances as well as of their final drug products. Our microbiologists have a wealth of experience in applying USP, Ph. Eur. and other international methods to a wide variety of biologics and traditional pharmaceuticals. Recognized as the global benchmark for quality and integrity, we are committed to providing you with the best-in-class services. Our teams of microbiologists help determine your needs and expectations to satisfy regulatory requirements. Our scientific approach is supported by our technical knowledge and expertise in microbiological testing. With extensive method validation expertise, our team of microbiologists ensures the quality and integrity of all test results. Our facilities meet the demanding cleanliness and engineering requirements of microbiological testing programs. Class 100 hoods, clean rooms and isolators are available for microbial evaluation. 


    Biological and microbiological testing services Our biological and microbiological testing services include:
    • Microbial limits tests (microbiological examination of non-sterile products) 
    • Sterility testing 
    • Microbial contaminant identification 
    • Antimicrobial effectiveness testing (sterile and non-sterile multi-dose forms) and microbial challenges 
    • Mycoplasma testing Microbiological assessment of antibiotics 
    • Bacterial endotoxins testing 
    • Sampling and analysis of water for pharmaceutical microbiology 
    • Chemical disinfectant testing and cleaning studies 
    • Environmental monitoring 
    • Microbiological attribute studies (e.g. barrier testing for packaging, condoms and medical gloves, and hygienic and antibacterial testing for contact lenses, personal care products, and more.) 
    • Non-viable particulate testing 


    To discuss your biological and microbiological testing requirements, contact us today.


  • Analytical Chemistry Services

    Product Analytical Chemistry Services

    Delivering a product from discovery to the market is a long and often difficult process filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced methods and instrumentation. SGS leverages its conveniently located network of laboratories present in North America, Europe and Asia-Pacific, to deliver harmonized solutions to local markets as well as international pharmaceutical and biotechnology firms. Our recognized experts assist in providing effective and efficient solutions for R&D, analytical development, and quality control testing, helping to expedite the molecule to market.
  • Stability Testing

    Product Stability Testing

    From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
    When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 25 years of experience and currently more than 100,000 samples on storage, our life science laboratories have the skills and capacity to handle your pharmaceutical and biologic stability projects.

    We provide a complete range of storage conditions in numerous climatic walk-in chambers and climatic cabinets with a total storage capacity of more than 2,400 m3. Various refrigerators and freezers are available for storage at lower temperatures. 
    All storage chambers are fully controlled with 24/7 monitoring and alert systems (21 CFR part 11 compliant). For your reassurance, we operate back-up chambers for complete sample retrieval.

    Stability study testing services We provide you with:

    - Support in designing studies for real-time, stress tests and photostability studies 
    - Development and validation of stability indicating methods Examination of stability-relevant parameters 
    - Storage and management of stability samples 
    - Interim reports for every testing period 
    - Comprehensive final report

    To find out more about our stability testing services, contact us today.


  • Package and Container Testing

    Product Package and Container Testing

     SGS realizes that the package or container that carries your product is vital to its safety and efficacy: a weak container, or one that allows contamination of your product, could put the health of your customers and your reputation at risk. SGS package and container testing services offer a range of tests to ensure that your packaging is fit for purpose and does not compromise your product.

    Our package and container tests are shaped to meet the needs of a wide range of clients across the pharmaceutical, biopharmaceutical, medical devices and related industries. Each has particular needs, so our services are flexible enough to be tailored into programs that can provide full-time support or a helping pair of hands during busy periods. All tests are conducted to meet the requirements of regulatory bodies and relevant pharmacopeia.

    Tests are conducted by our highly skilled specialists at one of our cutting-edge laboratories across the globe. They include tests on the raw materials used to make containers, tests on the final container and tests to examine the interaction between packaging and content, including extractables and leachables testing.



  • Cell bank and virus seed characterization

    Product Cell bank and virus seed characterization

    As a world leader in biopharmaceutical testing services, we offer you a comprehensive range of biologics safety testing , including virology, cell and molecular biology, as well as microbiology and electron microscopy. As a result, we can help you to ensure product safety and meet your regulatory requirements.

    We carry out cell bank and virus seed characterization in line with major compendia and regulatory guidelines. We also offer you final product testing for residual DNA and other process related impurities. Plus, we provide formulation and stability studies, regulatory and safety consultancy and the custom development of assays.

  • Bioanalysis Testing

    Product Bioanalysis Testing

    SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). 

SGS Group Management SA resources

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    SGS leverages its conveniently located network of laboratories and clinical trial facilities present in North America, Europe and Asia-Pacific, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. 
    Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services. We perform a variety of tests that are bespoke, client-specific and support the full clinical development, from Phase I First-in-Human trials in our Clinical Pharmacology Units to Phase II and Phase III studies in patients.
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  • Brochure Nitrosamine Impurities Testing Solutions

    SGS Life Sciences has considerable expertise in the method development of nitrosamine determination in pharmaceutical products. SGS has established a specific method for NDMA which can be applied to various different matrices. Alternatively, a platform method, based on trace-level detection by LC-MSMS, is also available and provides rapid and simultaneous determination of up to ten different, targeted nitrosamines. Although with more limited application, the SGS network is also able to support specialist methodologies such as GC-MSMS. Our experience in optimizing extraction procedures allows application of these methods to drug products, API’s, and raw materials. 

  • News Managing Your Life Sciences Quality Management System Remotely

    Telecommuting and online commerce has been with us for some time and works seamlessly in many industries, but the current state of events has forced companies to apply remote management to other areas that have historically been considered "hands-on" job functions.
  • Brochure Biologics Testing Services

    A full package of Biologics testing services to cGMP standards from early phase characterisation including Biosafety to Quality Control release testing enabling you to outsource your biologics.
  • News Vaccine Testing to Ensure Successful and Faster Vaccine Research and Development

    Following its emergence earlier this year, the novel coronavirus (SARS-CoV-2) has spread rapidly and snowballed into a pandemic. Everyone – citizens, businesses, and governments – yearns for life to go back to normal soon.
  • Brochure Analytical Chemistry Services

    Delivering a product from discovery to the market is a long and often difficult process filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced methods and instrumentation.


    SGS leverages its conveniently located network of laboratories present in North America, Europe and Asia-Pacific, to deliver harmonized solutions to local markets as well as international pharmaceutical and biotechnology firms.

    Our recognized experts assist in providing effective and efficient solutions for R&D, analytical development, and quality control testing, helping to expedite the molecule to market.
  • Brochure Bioanalysis Testing Solutions

    SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). CONTINUOUS
  • Brochure Biosafety Testing Solutions

    Life-saving medicines are heavily regulated during development, manufacture and distribution. To fulfill regulatory requirements, the biopharmaceutical industry is increasingly looking for independent service providers who can deliver comprehensive characterization solutions on one site. 
    SGS’s global center of excellence for cell bank characterization & virus testing is located in the United Kingdom and provides services with ultimate reliability, highest GLP/cGMP quality & scientific expertise. 
    As trailblazers in the development of the biosafety testing industry, our team in Glasgow have developed and validated novel nucleic acid technologies, such as real-time PCR, RAPD, Sequencing, Non
    radioactive Southern Blotting, Next Generation Sequencing (NGS). For any of your biologics, we help you comply with the global regulatory guidelines and testing requirements.
  • Video VIDEO: SGS vs COVID-19: Biologics Characterization Services

    SGS' integrated network of laboratories provides a wide range of essential services to support the fight against COVID-19. We provide established expertise and resources for all aspects of biopharmaceuticals characterization, from physico-chemical properties, to primary, secondary, and tertiary structures, as well as aggregation.
    For more information, contact [email protected] or visit: https://www.sgs.com/lifescience.
  • Video VIDEO: Extractables & Leachables Studies

    Watch to find out more about how our Extractables & Leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging, to ensure patient safety and drug product efficacy. 
    Visit https://www.sgs.com/en/life-sciences/ to find out more.
  • Video VIDEO: Nitrosamine Impurities Testing Services

    The presence of the #nitrosamine N-nitrosodimethylamine (#NDMA), in certain sartan APIs has resulted in several regulatory warnings and recalls of contaminated products. We have considerable expertise in the method development for detecting the presence of NDMA and other nitrosamines to help you to ensure product safety and comply with USFDA and EMA requirements.

    For more information, contact [email protected] or visit: https://www.sgs.com/lifescience.

    #Nitrosamine #DrugSafety #DrugDevelopment

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